Authorised Version C2019C00066 registered 22/01/2019
Therapeutic Goods Act 1989
No. 21, 1990
Compilation No. 72
Compilation date: 1 January 2019
Includes amendments up to: Act No. 104, 2018
Registered: 22 January 2019
Prepared by the Office of Parliamentary Counsel, Canberra
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Act 1989 that shows the text of
the law as amended and in force on 1 January 2019 (the compilation date).
The notes at the end of this compilation (the endnotes) include information
about amending laws and the amendment history of provisions of the compiled
law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the
compiled law. Any uncommenced amendments affecting the law are accessible
on the Legislation Register (www.legislation.gov.au). The details of
amendments made up to, but not commenced at, the compilation date are
underlined in the endnotes. For more information on any uncommenced
amendments, see the series page on the Legislation Register for the compiled
law.
Application, saving and transitional provisions for provisions and
amendments
If the operation of a provision or amendment of the compiled law is affected by
an application, saving or transitional provision that is not included in this
compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see
the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as
modified but the modification does not amend the text of the law. Accordingly,
this compilation does not show the text of the compiled law as modified. For
more information on any modifications, see the series page on the Legislation
Register for the compiled law.
Self-repealing provisions
If a provision of the compiled law has been repealed in accordance with a
provision of the law, details are included in the endnotes.
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Contents
Chapter 1—Preliminary 1 Short title...........................................................................1
2 Commencement.................................................................1
3 Interpretation .....................................................................1
3AA Homoeopathic preparations and homoeopathic
standards..........................................................................22
3AB Anthroposophic preparations and anthroposophic
standards..........................................................................23
3A Declaration—member of European Community .............24
3B Declaration—country covered by non-EC/EFTA
MRA................................................................................25
3C Exempting monographs in pharmacopoeias ....................25
4 Objects of Act..................................................................26
5 Act to bind Crown ...........................................................26
5A Application of the Criminal Code—extended
geographical jurisdiction .................................................26
6 Operation of Act..............................................................27
6AAA Commonwealth consent to conferral of functions
etc. on its officers and authorities by
corresponding State laws.................................................27
6AAB When duty imposed.........................................................28
6AAC Imposing duty under State law ........................................29
6AAD Conferral of jurisdiction on federal courts.......................30
6AAE Consequences of State law conferring duty,
function or power on Commonwealth officer or
Commonwealth authority ................................................31
6B Review of certain decisions under State laws..................32
6C Fees payable to Commonwealth under State laws...........32
7 Declaration that goods are/are not therapeutic
goods ...............................................................................33
7AA Excluded goods ...............................................................34
7A Authorised persons..........................................................34
7B Kits ..................................................................................35
7C Secretary may arrange for use of computer
programs to make decisions ............................................36
7D Form for product information for medicine.....................36
8 Power to obtain information with respect to
therapeutic goods.............................................................36
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9 Arrangements with States etc. .........................................37
Chapter 2—Australian Register of Therapeutic Goods 39 9A Australian Register of Therapeutic Goods.......................39
9B When registrations or listings of medical devices
are taken to be cancelled..................................................40
9C Inspection of entries in Register ......................................42
9D Variation of entries in Register........................................43
9E Publication of list of goods on Register...........................48
9F Removal of entries from Register....................................49
9G Criminal offences for false statements in requests
for variation of entries in Register ...................................50
9H Civil penalty for false statements in requests for
variation of entries in Register.........................................51
Chapter 3—Medicines and other therapeutic goods
that are not medical devices 52
Part 3-1—Standards 52 10 Determination of standards..............................................52
10A Application of standards to medical devices ...................53
13 Special provisions relating to Ministerial standards
and default standards .......................................................54
13A Special provisions relating to homoeopathic
standards and anthroposophic standards..........................55
14 Criminal offences for importing, supplying or
exporting goods that do not comply with standards ........56
14A Civil penalties for importing, supplying or
exporting goods that do not comply with standards ........61
14B Application of Customs Act 1901 ....................................63
15 Criminal offences relating to breaching a condition
of a consent .....................................................................63
15AA Civil penalty relating to breaching a condition of a
consent ............................................................................64
15AB Conditions relating to exceptional release of
biologicals .......................................................................65
Part 3-2—Registration and listing of therapeutic goods 66
Division 1—Preliminary 66
15A Application of this Part to medical devices .....................66
15B Application of this Part to a biological ............................68
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16 Therapeutic goods and gazetted groups...........................69
18 Exempt goods..................................................................71
18A Exemption because of emergency ...................................71
19 Exemptions for certain uses.............................................75
19A Exemptions where unavailability etc. of
therapeutic goods.............................................................80
19B Criminal offences relating to registration or listing
etc. of imported, exported, manufactured and
supplied therapeutic goods ..............................................83
19C Notice required to adduce evidence in support of
exception under subsection 19B(6) .................................86
19D Civil penalties relating to registration or listing etc.
of imported, exported, manufactured and supplied
therapeutic goods.............................................................88
20 Criminal offences relating to notifying the
Secretary and to importing goods exempt under
section 18A......................................................................90
20A Civil penalty relating to the importation,
exportation, manufacture or supply of sponsored
goods without proper notification....................................92
21 Offence relating to wholesale supply ..............................94
21A General criminal offences relating to this Part ................94
21B General civil penalties relating to this Part....................102
22 General offences relating to this Part.............................103
22AA Civil penalty for breaching a condition of an
exemption......................................................................106
22A Criminal offences for false statements in
applications for registration...........................................107
22B Civil penalty for false statements in applications
for registration ...............................................................108
Division 1A—Provisional determinations for medicine 109
22C Applications for provisional determination ...................109
22D Provisional determinations ............................................109
22E Period during which provisional determination is
in force ..........................................................................110
22F Revocation of provisional determination.......................112
Division 2—Registration and listing 114
23 Applications generally...................................................114
23AA Applications for provisional registration of
medicine ........................................................................114
23A Classes of therapeutic goods .........................................114
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23B Requirements relating to applications for
registration of therapeutic goods and listing of
medicines under section 26AE ......................................114
23C Requirements relating to applications for listing of
therapeutic goods under section 26 or 26A ...................117
24 Applications for registration..........................................117
24A When evaluation fee due for payment ...........................118
24B Payment of evaluation fee by instalments .....................119
24C Recovery of evaluation fee ............................................119
24D Refund of evaluation fee where evaluation not
completed within prescribed period...............................119
24E Deemed refusal of application.......................................120
25 Evaluation of therapeutic goods ....................................120
25AAA Therapeutic goods (priority applicant)
determinations ...............................................................124
25AA Approved product information for medicine .................126
25AB Registration of therapeutic goods etc. ...........................129
25AC Notice of decision not to register therapeutic goods......130
25A When the Secretary must not use protected
information....................................................................131
25B Registration of therapeutic device to which
EC/EFTA attestation of conformity applies ..................132
26 Listing of therapeutic goods ..........................................132
26AA Listing of therapeutic device to which EC/EFTA
attestation of conformity applies ...................................137
26A Listing of certain medicines ..........................................137
26AB Application for listing of certain medicines
following efficacy evaluation ........................................142
26AC Evaluation fees for listing of medicine under
section 26AE .................................................................146
26AD Lapsing and deemed refusal of applications for
listing of medicine under section 26AE.........................147
26AE Evaluation and listing of certain medicines ...................148
26B Certificates required in relation to patents .....................150
26BA Approved form for notices ............................................151
26BB Permissible ingredients..................................................151
26BC Variation of determination under section 26BB—
Minister’s initiative .......................................................152
26BE Variation of section 26BB determination—
application by person.....................................................153
26BF Permissible indications..................................................156
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26BG Limitations on determination under section 26BF.........157
26BH Variation of determination under section 26BF—
Minister’s initiative .......................................................157
26BJ Variation of determination under section 26BF—
application by person.....................................................157
26C Certificates required in relation to patent
infringement proceedings ..............................................160
26D Requirements for interlocutory injunction.....................163
27 Registration or listing number .......................................165
28 Conditions of registration or listing...............................165
28A Certification of manufacturing steps outside
Australia following application for listing.....................170
29 Duration of registration or listing ..................................170
29A Criminal offence for failing to notify adverse
effects etc. of goods.......................................................173
29AA Civil penalty for failing to notify adverse effects
etc. of goods ..................................................................174
29B Notification of adverse effects etc. where
application withdrawn or lapses ....................................175
29C Civil penalties for failing to notify adverse effects
etc. where application withdrawn or lapses ...................176
29D Suspension of registration or listing ..............................176
29E When suspension takes effect etc. .................................177
29F Revocation of suspension ..............................................178
29G Effect of suspension ......................................................179
30 Cancellation of registration or listing ............................180
30A Revocation of cancellation of registration or listing
upon request ..................................................................184
30AA Revocation of cancellation of registration or
listing—payment of annual registration or listing
charge ............................................................................185
30B Publication of cancellation of registration or listing......185
30C Consultation with Gene Technology Regulator.............186
30D Secretary may seek advice about classes of GM
products or genetically modified organisms ..................186
30E Secretary to take advice into account ............................187
Division 2A—Public notification, and recall, of therapeutic
goods 188
30EA Public notification, and recall, of therapeutic
goods .............................................................................188
30EB Publication of requirements...........................................191
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30EC Criminal offences for non-compliance with
requirements ..................................................................191
30ECA Civil penalty for non-compliance with
requirements ..................................................................192
30ED Powers of suspension and cancellation unaffected ........192
30EE Saving of other laws ......................................................192
Division 2B—Reporting medicine shortages and discontinuation
of supply of medicine 193
30EF Reporting medicine shortages .......................................193
30EG Reporting discontinuation of supply of medicine ..........195
30EH What is a reportable medicine? .....................................197
30EI When is there a medicine shortage? ..............................197
30EJ Medicines Watch List....................................................198
Division 3—General 199
30F Criminal offences for goods exempt under
section 18A not conforming to standards etc.................199
30FA Civil penalty for goods exempt under section 18A
not conforming to standards etc.....................................201
30G Disposal of unused goods exempt under
section 18A....................................................................201
30H Record for goods exempt under section 18A.................202
31 Secretary may require information or documents..........203
31AAA Civil penalty for providing false or misleading
information or documents in relation to therapeutic
goods .............................................................................209
31A Secretary may require information etc. about
goods exempt under section 18 .....................................210
31AA Secretary may require information etc. about
goods exempt under section 18A...................................211
31B Secretary may require information relating to
approvals and authorities under section 19....................212
31BA Secretary may require information about
therapeutic goods approved under section 19A.............214
31C Criminal offences for failing to give information
or documents sought under section 31A, 31AA,
31B or 31BA .................................................................215
31D False or misleading information ....................................215
31E False or misleading documents......................................216
31F Self-incrimination..........................................................217
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Part 3-2A—Biologicals 219
Division 1—Preliminary 219
32 What this Part is about...................................................219
32A Meaning of biological ...................................................219
32AA Biological classes ..........................................................220
32AB When biologicals are separate and distinct from
other biologicals ............................................................221
Division 2—Main criminal offences and civil penalties 222
32B What this Division is about ...........................................222
32BA Criminal offences for importing a biological ................222
32BB Criminal offences for exporting a biological .................225
32BBA Treating biologicals as prohibited imports or
exports ...........................................................................227
32BC Criminal offences for manufacturing a biological .........227
32BD Criminal offences for supplying a biological ................230
32BE Notice required to adduce evidence in support of
exception to offences.....................................................233
32BF Civil penalties for importing, exporting,
manufacturing or supplying a biological .......................235
32BG Criminal offences and civil penalty relating to a
failure to notify the Secretary about manufacturing ......238
32BH Criminal offence relating to wholesale supply ..............241
32BI Criminal offence for using a biological not
included in the Register .................................................242
32BJ General criminal offences relating to this Part ..............244
32BK Civil penalty for making misrepresentations about
biologicals .....................................................................246
32BL Civil penalty for advertising biological for an
indication.......................................................................247
Division 3—Exemptions 248
Subdivision A—Preliminary 248
32C What this Division is about ...........................................248
Subdivision B—Exempting biologicals under the regulations 248
32CA Exempt biologicals ........................................................248
Subdivision C—Exempting biologicals to deal with emergencies 249
32CB Minister may make exemptions.....................................249
32CC Conditions of exemptions..............................................250
32CD Variation or revocation of exemption............................251
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32CE Informing persons of exemption etc. .............................252
32CF Notification and tabling.................................................252
32CG Disposal of unused biologicals ......................................253
32CH Criminal offences for breaching a condition of an
exemption......................................................................253
32CI Civil penalty for breaching a condition of an
exemption......................................................................255
32CJ Criminal offences and civil penalty for biologicals
not conforming to standards etc.....................................255
Subdivision D—Exempting biologicals for certain uses 258
32CK Approvals for importing, exporting or supplying a
biological for special and experimental uses .................258
32CL Conditions of use of biological for experimental
purposes in humans .......................................................260
32CM Exemptions for health practitioners...............................260
32CN Criminal offences relating to the giving of an
authority to a health practitioner....................................263
Subdivision E—Exempting biologicals where substitutes are
unavailable etc. 267
32CO Approvals where substitutes for biologicals are
unavailable etc...............................................................267
Division 4—Including biologicals in the Register 271
Subdivision A—Preliminary 271
32D What this Division is about ...........................................271
Subdivision B—Class 1 biologicals 271
32DA Application for inclusion in the Register .......................271
32DB Inclusion of Class 1 biological in the Register ..............272
32DC Refusal to include Class 1 biological in the
Register .........................................................................273
Subdivision C—Biologicals other than Class 1 biologicals 273
32DD Application for inclusion in the Register .......................273
32DDA Preliminary assessment of applications .........................273
32DE Evaluation of biologicals...............................................275
32DEA Biologicals (priority applicant) determinations .............276
32DF Inclusion of biological in the Register...........................278
32DG Refusal to include biological in the Register .................279
32DH Lapsing of application ...................................................280
32DI Evaluation fee................................................................280
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32DJ When evaluation fee due for payment ...........................281
32DK Payment of evaluation fee by instalments .....................281
32DL Recovery of evaluation fee ............................................281
32DM Reduction of evaluation fee where evaluation not
completed within prescribed period...............................282
Subdivision D—Transitional provisions for existing biologicals 283
32DN Transitional provisions for existing biologicals.............283
Subdivision E—Criminal offences and civil penalties 285
32DO Criminal offences for false statements in
applications for including biologicals in the
Register .........................................................................285
32DP Civil penalty for false statements in applications
for including biologicals in the Register........................286
32DQ Criminal offence and civil penalty for failing to
notify adverse effects etc. of biological while it is
included in the Register .................................................287
32DR Criminal offences and civil penalties for failing to
notify adverse effects etc. of biological where
application withdrawn or lapses ....................................288
Subdivision F—Advice from Gene Technology Regulator 290
32DS Consultation with Gene Technology Regulator.............290
32DT Secretary may seek advice about classes of GM
products or genetically modified organisms ..................291
32DU Secretary to take advice into account ............................291
Division 5—Conditions 293
32E What this Division is about ...........................................293
32EA Conditions applying automatically ................................293
32EB Certification of manufacturing steps outside
Australia ........................................................................296
32EC Imposition of conditions by legislative instrument........296
32ED Imposition of conditions at time biological
included in the Register .................................................297
32EE Imposition or variation or removal of conditions
after biological included in the Register ........................297
32EF Criminal offences for breach of condition.....................298
32EG Civil penalty for breach of condition.............................299
Division 6—Suspension from the Register 300
32F What this Division is about ...........................................300
32FA Suspension of biological from the Register ...................300
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32FB When suspension takes effect etc. .................................301
32FC Revocation of suspension ..............................................302
32FD Effect of suspension ......................................................303
Division 7—Cancellation from the Register 304
32G What this Division is about ...........................................304
32GA Immediate cancellation of biological from the
Register in various circumstances .................................304
32GB Immediate cancellation of biological from the
Register after failure to comply with information
gathering notice .............................................................305
32GC Cancellation of biological from the Register after
notice of proposed cancellation .....................................306
32GD Revocation of cancellation of biological upon
request ...........................................................................308
32GDA Revocation of cancellation of biological upon
request—payment of annual charge ..............................308
32GE Publication of cancellation of entry from Register ........309
32GF Date of effect of cancellation of entries from
Register .........................................................................309
Division 8—Public notification, and recall, of biologicals 310
32H What this Division is about ...........................................310
32HA Public notification, and recall, of biologicals ................310
32HB Publication of requirements...........................................313
32HC Criminal offences for non-compliance with
requirements ..................................................................314
32HD Civil penalty for non-compliance with
requirements ..................................................................314
32HE Powers of suspension and cancellation unaffected ........315
32HF Saving of other laws ......................................................315
Division 9—Obtaining information or documents 316
Subdivision A—Preliminary 316
32J What this Division is about ...........................................316
Subdivision B—Obtaining information or documents for
biologicals included or proposed to be included in
the Register 316
32JA Secretary may require information or documents..........316
32JB Criminal offences for failing to comply with a
notice etc. ......................................................................318
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32JC Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................320
32JD Self-incrimination..........................................................320
Subdivision C—Obtaining information or documents for
biologicals covered by exemptions 321
32JE Secretary may require information etc. about
biologicals exempt under the regulations ......................321
32JF Secretary may require information etc. about
biologicals exempt to deal with emergencies ................322
32JG Secretary may require information etc. about
biologicals exempt for special and experimental
uses................................................................................323
32JH Secretary may require information etc. about
biologicals exempt where substitutes are
unavailable etc...............................................................325
32JI Criminal offences for failing to comply with a
notice etc. ......................................................................326
32JJ Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................327
32JK Self-incrimination..........................................................328
Subdivision D—Inspecting, copying and retaining documents 328
32JL Secretary may inspect and copy documents ..................328
32JM Secretary may retain documents....................................329
Part 3-3—Manufacturing of therapeutic goods 330 33A Application of this Part to medical devices ...................330
33B Application of this Part to biologicals ...........................330
34 Exempt goods and exempt persons ...............................330
35 Criminal offences relating to manufacturing
therapeutic goods...........................................................330
35A Civil penalties relating to manufacturing
therapeutic goods...........................................................333
35B Criminal offences relating to breaching a condition
of a licence ....................................................................334
35C Civil penalty relating to breaching a condition of a
licence ...........................................................................335
36 Manufacturing principles...............................................335
37 Application for licence ..................................................336
38 Grant of licence .............................................................338
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38A Guidelines for multi-site licences ..................................341
38B Splitting multi-site licences ...........................................341
39 Term of licence..............................................................343
40 Conditions of licences ...................................................344
40A Variation of manufacturing site authorisations—
Secretary’s own initiative ..............................................347
40B Variation of licences—application by licence
holder ............................................................................347
41 Revocation and suspension of licences..........................350
41AAAA Withdrawal of revocation of licence upon request ........353
41AA Spent convictions scheme..............................................353
41AB Secretary may require information or documents..........353
41AC Criminal offence for contravening a requirement
in a notice under section 41AB......................................355
41AD False or misleading information—offence ....................355
41AE False or misleading documents—offence......................356
41AF False or misleading information or documents—
civil penalty...................................................................357
41AG Self-incrimination..........................................................358
41AAA Transfer of licences .......................................................358
41A Publication of list of manufacturers etc. ........................359
Chapter 4—Medical devices 360
Part 4-1—Introduction 360
Division 1—Overview of this Chapter 360
41B General ..........................................................................360
41BA Requirements for medical devices (Parts 4-2 and
4-3)................................................................................360
41BB Administrative processes (Parts 4-4 to 4-10).................360
41BC Enforcement (Part 4-11)................................................361
Division 2—Interpretation 362
41BD What is a medical device ...............................................362
41BE Kinds of medical devices...............................................363
41BEA Excluded purposes.........................................................364
41BF System or procedure packs ............................................364
41BG Manufacturers of medical devices .................................365
41BH Meaning of compliance with essential principles ..........366
41BI Meaning of non-application of conformity
assessment procedures...................................................366
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41BIA Meaning of non-application of overseas
requirements comparable to conformity
assessment procedures...................................................367
41BIB Overseas regulators .......................................................367
Division 3—Application provisions 369
41BJ Application of this Chapter to medical devices
covered by Part 3-2........................................................369
41BJA Application of this Chapter to a biological ....................369
41BK Application of the Criminal Code .................................371
Part 4-2—Essential principles and medical device standards 372 41C What this Part is about...................................................372
Division 1—Essential principles 373
41CA Essential principles........................................................373
Division 2—Medical device standards 374
41CB Medical device standards ..............................................374
41CC Content of medical device standards .............................374
41CD Inconsistencies between medical device standards........375
Part 4-3—Conformity assessment procedures 376 41D What this Part is about...................................................376
Division 1—Conformity assessment procedures 377
41DA Conformity assessment procedures ...............................377
41DB Medical device classifications .......................................378
Division 2—Conformity assessment standards 379
41DC Conformity assessment standards..................................379
41DD Content of conformity assessment standards.................379
41DE Inconsistencies between conformity assessment
standards........................................................................380
Part 4-4—Conformity assessment certificates 381 41E What this Part is about...................................................381
Division 1—Issuing conformity assessment certificates 382
41EA When conformity assessment certificates are
required .........................................................................382
41EB Applications ..................................................................382
41EC Considering applications ...............................................383
41ECA Conformity assessment (priority applicant)
determinations ...............................................................385
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41ED Time for making decisions on applications ...................387
41EE Procedure following making a decision whether to
issue certificate ..............................................................387
41EF Duration of certificate ...................................................388
41EG Lapsing of applications .................................................388
41EH Treating applications as having been refused ................389
41EI Criminal offences for making a false statement ............390
41EIA Civil penalty for making a false statement ....................391
Division 2—Conditions 392
41EJ Automatic conditions on conformity assessment
certificates .....................................................................392
41EK Conditions imposed when conformity assessment
certificates are issued.....................................................394
41EL Conditions imposed after issuing a conformity
assessment certificate ....................................................394
Division 3—Suspension of conformity assessment certificates 396
41EM Suspension of conformity assessment certificates .........396
41EN Notice of proposed suspension ......................................396
41EO Duration of suspension..................................................397
41EP Revocation of suspension ..............................................397
41EQ Powers of revocation of conformity assessment
certificates unaffected....................................................398
Division 4—Revocation of conformity assessment certificates 399
41ER Automatic revocation of conformity assessment
certificates .....................................................................399
41ES Immediate revocation of conformity assessment
certificates .....................................................................399
41ET Revocation of conformity assessment certificates
after notice of proposed revocation ...............................400
41EU Limiting revocation of conformity assessment
certificates to some medical devices of a particular
kind................................................................................402
41EV Publication of revocation etc. of conformity
assessment certificates...................................................402
41EW Date of effect of revocation etc. of conformity
assessment certificates...................................................403
Part 4-4A—Australian conformity assessment bodies 404 41EWA Conformity assessment body determinations ................404
41EWB Content of Australian conformity assessment body
certificates .....................................................................407
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41EWC Duration of Australian conformity assessment
body certificates ............................................................407
41EWD Record-keeping .............................................................408
Part 4-5—Including medical devices in the Register 410 41F What this Part is about...................................................410
Division 1—Including medical devices in the Register 411
41FA What this Division is about ...........................................411
Subdivision A—Applications 411
41FC Making an application ...................................................411
41FD Matters to be certified....................................................411
41FDA Basis of certification of conformity assessment
procedures .....................................................................413
41FDB Preliminary assessment of applications .........................413
41FE Criminal offences for making a false statement ............415
41FEA Civil penalty for making a false statement ....................417
Subdivision B—Including kinds of medical devices in the Register 417
41FF Obligation to include kinds of medical devices in
the Register....................................................................417
41FG Notification of unsuccessful applications ......................418
Subdivision C—Auditing of applications 418
41FH Selecting applications for auditing ................................418
41FI Auditing of applications ................................................419
41FIA Certificates issued by Australian conformity
assessment bodies..........................................................420
41FJ Procedure following audits............................................420
41FK Lapsing of applications .................................................421
Subdivision D—Miscellaneous 422
41FKA Medical devices (priority applicant)
determinations ...............................................................422
41FL Device number ..............................................................423
41FM Duration of inclusion in the Register.............................424
Division 2—Conditions 425
41FN Conditions applying automatically ................................425
41FO Conditions imposed when kinds of medical
devices are included in the Register ..............................428
41FP Conditions imposed after kinds of medical devices
are included in the Register ...........................................428
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Part 4-6—Suspension and cancellation from the Register 430
Division 1—Suspension from the Register 430
Subdivision A—General power of suspension 430
41G What this Part is about...................................................430
41GA Suspension of kinds of medical devices from the
Register .........................................................................430
41GB Notice of proposed suspension must be given in
certain cases ..................................................................431
41GC Duration of suspension..................................................431
41GD Revocation of suspension ..............................................432
41GE Treating applications for revocation as having
been refused ..................................................................433
Subdivision B—Suspension as a result of suspension of conformity
assessment document 434
41GF Suspension where conformity assessment
certificate suspended .....................................................434
41GFA Suspension where other certificates or documents
are suspended ................................................................434
41GG Duration of suspension..................................................435
41GH Revocation of suspension ..............................................435
Subdivision C—Effect of suspension 436
41GI Effect of suspension ......................................................436
41GJ Powers of cancellation from Register unaffected ..........436
Division 2—Cancellation of entries from the Register 437
41GK Automatic cancellation of entries of kinds of
medical devices from the Register.................................437
41GL Immediate cancellation of entries of kinds of
medical devices from the Register.................................437
41GLA Revocation of cancellation of entries upon request .......438
41GLB Revocation of cancellation of entries—payment of
annual charge ................................................................439
41GM Cancellation of entries of kinds of medical devices
from the Register after section 41JA notice...................440
41GN Cancellation of entries of kinds of medical devices
from the Register after notice of proposed
cancellation ...................................................................441
41GO Limiting cancellation of entries from Register to
some medical devices of a particular kind.....................442
41GP Publication of cancellation of entry from Register ........443
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41GQ Date of effect of cancellation of entries from
Register .........................................................................443
Part 4-6A—Exempting medical devices to deal with
emergencies 444 41GR What this Part is about...................................................444
41GS Minister may make exemptions.....................................444
41GT Conditions of exemptions..............................................445
41GU Variation or revocation of exemption............................446
41GV Informing persons of exemption etc. .............................447
41GW Notification and tabling.................................................447
41GY Disposal of unused medical devices ..............................448
Part 4-7—Other exemptions from including medical devices in
the Register 449 41H What this Part is about...................................................449
41HA Devices exempted from inclusion in the Register .........449
41HB Exemptions for special and experimental uses ..............450
41HC Exemptions for health practitioners...............................452
41HD Approvals if substitutes for medical devices are
unavailable or in short supply........................................454
Part 4-8—Obtaining information 459 41J What this Part is about...................................................459
Division 1—Information relating to compliance with
requirements and other matters 460
41JA Secretary may require information or documents..........460
41JB Complying with the Secretary’s requirements...............462
41JBA Civil penalty for giving false or misleading
information in purported compliance with a notice .......465
41JC Self-incrimination..........................................................465
Division 2—Information relating to medical devices covered by
exemptions 466
41JCA Secretary may require information etc. about
medical devices exempt under Part 4-6A ......................466
41JD Secretary may require information etc. about
devices exempted under section 41HA from
inclusion in the Register ................................................466
41JE Secretary may require information relating to
approvals under section 41HB.......................................468
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41JF Secretary may require information relating to
health practitioner authorisations...................................469
41JFA Secretary may require information relating to
approvals under section 41HD ......................................470
41JG Criminal offences for failing to give information
or documents sought under this Division ......................471
41JH False or misleading information ....................................471
41JI False or misleading documents......................................472
41JJ Self-incrimination..........................................................473
Part 4-9—Public notification, and recall, of medical devices 475 41K What this Part is about...................................................475
41KA Public notification, and recall, of medical devices ........475
41KB Publication of requirements...........................................478
41KC Criminal offences for failing to comply with
requirements relating to a kind of medical device .........479
41KCA Civil penalty for failing to comply with
requirements relating to a kind of medical device .........480
41KD Powers of suspension and cancellation unaffected ........480
41KE Saving of other laws ......................................................480
Part 4-10—Assessment fees 481 41L What this Part is about...................................................481
41LA Assessment fees.............................................................481
41LB When assessment fee due for payment ..........................482
41LC Payment of assessment fee by instalments ....................482
41LD Recovery of assessment fee...........................................482
41LE Reduction of conformity assessment fee where
decision not made within prescribed period ..................483
Part 4-11—Offences and civil penalty provisions relating to
medical devices 484 41M What this Part is about...................................................484
Division 1—Non-compliance with essential principles 485
41MA Criminal offences for importing, supplying or
exporting a medical device that does not comply
with essential principles ................................................485
41MAA Civil penalties for importing, supplying or
exporting a medical device that does not comply
with essential principles ................................................489
41MB Exceptions .....................................................................490
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41MC Criminal offences relating to breaching a condition
of a consent ...................................................................491
41MCA Civil penalty relating to breaching a condition of a
consent ..........................................................................492
41MD Treating medical devices as prohibited imports or
exports ...........................................................................492
Division 2—Failure to apply conformity assessment procedures 493
41ME Criminal offences for failing to apply conformity
assessment procedures—manufacturers ........................493
41MEA Civil penalties for failing to apply conformity
assessment procedures—manufacturers ........................496
41MF Criminal offences for failing to apply conformity
assessment procedures—sponsors.................................496
41MG Exceptions .....................................................................499
41MH Criminal offence for making false statements in
declarations ...................................................................499
41MHA Civil penalty for making false statements in
declarations ...................................................................500
Division 3—Medical devices not included in the Register and
related matters 501
41MI Criminal offences for importing, exporting,
supplying or manufacturing a medical device not
included in the Register .................................................501
41MIA Notice required to adduce evidence in support of
exception under subsection 41MI(7) .............................504
41MIB Civil penalty for importing, exporting, supplying
or manufacturing a medical device not included in
the Register....................................................................506
41MJ Treating medical devices as prohibited imports or
exports ...........................................................................506
41MK Wholesale supply of medical devices not included
in the Register................................................................507
41ML False advertising about medical devices........................508
41MLA Civil penalty for making misrepresentations about
medical devices .............................................................509
41MLB Civil penalty for false advertising about medical
devices...........................................................................509
41MM Claims about arranging supplies of medical
devices...........................................................................510
41MN Criminal offences relating to breaches of
conditions ......................................................................510
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41MNA Civil penalties for breaching conditions ........................513
Division 3A—Offences and civil penalties related to exemptions
under Part 4-6A
41MNB Criminal offences for breaching a condition of an
exemption......................................................................515
41MNC Civil penalty for breaching a condition of an
exemption......................................................................516
41MND Civil penalty for making misrepresentations about
medical devices .............................................................516
Division 4—Other offences and civil penalty provisions 518
41MO Criminal offences for misusing medical devices
exempted for special or experimental uses ....................518
41MP Criminal offence for failing to notify adverse
events etc. ......................................................................522
41MPA Civil penalty for failing to notify adverse events
etc. .................................................................................523
41MPB Relief from liability for contraventions for failing
to notify adverse events etc. ..........................................525
41MQ Notification of adverse events etc. where
application withdrawn or lapses ....................................526
41MR Civil penalties for failing to notify adverse effects
etc. where application withdrawn or lapses ...................527
Chapter 5—Advertising, counterfeit therapeutic
goods and product tampering 528
Part 5-1—Advertising and generic information 528
Division 1—Preliminary 528
42AA This Part not to apply to advertisements directed at
health professionals etc. ................................................528
42AB This Part not to apply to advertisements for goods
not for human use..........................................................529
42AC This Part not to apply to advertisements for
exported goods ..............................................................529
42B Definitions.....................................................................529
42BAA Therapeutic Goods Advertising Code ...........................531
Division 2—Therapeutic goods advertisements for which an
approval is required 532
42BA Application of Division .................................................532
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42C Offences relating to publication of advertisements .......532
Division 3—General provisions about advertising therapeutic
goods 535
42DA Simplified outline..........................................................535
42DB Definitions.....................................................................535
42DD Restricted representations..............................................535
42DE Applications for approval of use of restricted
representation ................................................................536
42DF Approval of use of restricted representation..................536
42DG Notice of approval or refusal .........................................537
42DH Variation of conditions of approval ...............................537
42DI Withdrawal of approval .................................................537
42DJ Prohibited and required representations ........................538
42DK Permitted use of restricted or prohibited
representations...............................................................539
Division 3A—Therapeutic goods advertisements for which an
approval is not required 540
42DKA Application of Division .................................................540
42DKB Certain representations not to be advertised ..................540
42DL Advertising offences—general ......................................540
42DLA Advertising offences—contravening
section 42DKB notice ...................................................544
42DLB Civil penalty relating to advertisements—general.........545
42DLC Civil penalty relating to advertisements—
contravening section 42DKB notice..............................547
42DM Offences—non-compliance with the Therapeutic
Goods Advertising Code ...............................................548
42DMA Civil penalty—non-compliance with the
Therapeutic Goods Advertising Code ...........................549
Division 4—Generic information about ingredients or
components of therapeutic goods 551
42DN Application of Division .................................................551
42DO Compliance with the Code ............................................551
42DP Offences—dissemination of generic information ..........551
42DQ Civil penalty for dissemination of generic
information....................................................................552
Division 5—Secretary may require information or documents 553
42DR Secretary may require information or documents..........553
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42DS Criminal offences for failing to comply with a
notice etc. ......................................................................554
42DT Civil penalty for giving false or misleading
information or document in compliance with a
notice.............................................................................555
42DU Self-incrimination..........................................................555
Division 6—Directions about advertisements or generic
information 556
42DV Directions about advertisements or generic
information....................................................................556
42DW Offences—contravening direction under
section 42DV.................................................................557
42DX Civil penalty for contravening direction under
section 42DV.................................................................558
Division 7—Public warning notices 560
42DY Secretary may issue a public warning notice.................560
Part 5-2—Counterfeit therapeutic goods 561 42E Offence of dealing with counterfeit therapeutic
goods .............................................................................561
42EA Civil penalty relating to dealing with counterfeit
therapeutic goods...........................................................562
42EB Relief from liability for certain contraventions
relating to dealing with counterfeit therapeutic
goods .............................................................................562
42F Customs treatment of counterfeit therapeutic
goods .............................................................................563
Part 5-3—Product tampering 565 42T Notifying of actual or potential tampering ....................565
42U Meaning of actual or potential tampering etc. ..............566
42V Recall of therapeutic goods because of actual or
potential tampering........................................................567
42VA Civil penalty relating to the recall of therapeutic
goods because of actual or potential tampering.............569
42VB Relief from liability for contraventions relating to
the recall of therapeutic goods because of actual or
potential tampering........................................................569
42W Supply etc. of therapeutic goods that are subject to
recall requirements ........................................................570
42X Saving of other laws ......................................................571
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Chapter 5A—Enforcement 572
Part 5A-1—Civil penalties 572
Division 1—Obtaining an order for a civil penalty 572
42Y Federal Court may order person to pay pecuniary
penalty for contravening civil penalty provision ...........572
42YA What is a civil penalty provision?..................................573
42YC Persons involved in contravening civil penalty
provision........................................................................573
42YCA Continuing contraventions of civil penalty
provisions ......................................................................574
42YD Recovery of a pecuniary penalty ...................................574
42YE Gathering information for application for
pecuniary penalty ..........................................................574
Division 2—Civil penalty proceedings and criminal proceedings 576
42YF Civil proceedings after criminal proceedings ................576
42YG Criminal proceedings during civil proceedings .............576
42YH Criminal proceedings after civil proceedings ................576
42YI Evidence given in proceedings for civil penalty not
admissible in criminal proceedings ...............................576
Part 5A-2—Infringement notices 578 42YJ Simplified outline of this Part........................................578
42YK When an infringement notice may be given ..................578
42YKA Matters to be included in an infringement notice ..........579
42YKB Extension of time to pay amount ...................................581
42YKC Withdrawal of an infringement notice ...........................582
42YKD Effect of payment of amount .........................................583
42YKE Effect of this Part...........................................................584
Part 5A-3—Enforceable undertakings 585 42YL Enforcement of undertakings ........................................585
Part 5A-4—Injunctions 586 42YM Simplified outline of this Part........................................586
42YN Grant of injunctions.......................................................586
42YO Interim injunctions ........................................................587
42YP Discharging or varying injunctions ...............................587
42YQ Certain limits on granting injunctions not to apply .......587
42YR Other powers of court unaffected ..................................588
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Chapter 6—Administration 589
Part 6-1—Payment of charges 589 43 By whom charges payable.............................................589
44 Time for payment of charges.........................................589
44A Exemptions from liability to pay charges ......................590
44B Recovery of unpaid charges ..........................................592
45 Therapeutic Goods Administration Account .................593
Part 6-2—Entry, searches and warrants 595 45A Definitions.....................................................................595
46 Searches to monitor compliance with Act or
regulations .....................................................................596
46A Searches of certain premises to monitor
compliance with Act......................................................596
46B Searches and seizures on public health grounds ............598
47 Searches and seizures related to offences and civil
penalty provisions .........................................................599
48 General powers of authorised persons in relation to
premises ........................................................................600
48A Details of warrant to be given to occupier etc. ..............601
48AA Completing execution of warrant under section 50
after temporary cessation...............................................602
48B Announcement before entry ..........................................603
48BA Use of electronic equipment at premises for
monitoring compliance with Act or regulations ............603
48C Use of electronic equipment at premises relating to
offences and civil penalty provisions ............................605
48D Compensation for damage to electronic equipment.......607
48E Copies of seized things to be provided ..........................607
48F Occupier entitled to be present during search................608
48FA Responsibility to provide facilities and assistance.........608
48G Receipts for things seized under warrant .......................609
48H Retention of seized things .............................................609
48J Magistrate may permit a thing to be retained ................610
49 Monitoring warrants ......................................................610
50 Offence and civil penalty provision related
warrants .........................................................................611
51 Offence and civil penalty provision related
warrants by telephone....................................................612
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51A Inspections for purposes of Mutual Recognition
Convention ....................................................................614
51B Offences relating to warrants.........................................614
52 Identity cards .................................................................615
Part 6-3—Scheduling of substances 616 52AA Overview.......................................................................616
52A Definitions.....................................................................616
52B Advisory Committee on Medicines Scheduling ............617
52C Advisory Committee on Chemicals Scheduling ............618
52CA Joint meetings................................................................619
52D Poisons Standard ...........................................................619
52E Secretary to take certain matters into account in
exercising powers ..........................................................620
52EAA Application for amendment of the Poisons
Standard ........................................................................621
52EB Compensation for acquisition of property .....................622
52EC Review of scheduling regime ........................................622
Chapter 7—Miscellaneous 624 53 Retention of material on withdrawal of application ......624
53A Alternative verdicts for various offences.......................624
54 Offences and forfeiture..................................................627
54AA Offences for contravening conditions or
requirements imposed under the regulations .................627
54AB Criminal offence for damaging etc. documents .............628
54AC Civil penalty for damaging etc. documents ...................628
54A Time for bringing prosecutions .....................................629
54B Personal liability of an executive officer of a body
corporate—general ........................................................629
54BA Personal liability of an executive officer of a body
corporate—offences covered.........................................630
54C Establishing whether an executive officer took
reasonable steps to prevent the commission of an
offence or the contravention of a civil penalty
provision........................................................................633
55 Conduct by directors, employees and agents.................633
56 Judicial notice................................................................635
56A Certificates to provide evidence of certain matters........635
57 Delegation .....................................................................638
58 Export certifications ......................................................640
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59 Fees ...............................................................................641
60 Review of decisions.......................................................641
60A New information on review—discretion to remit ..........646
61 Release of information ..................................................650
61A Immunity from civil actions ..........................................656
63 Regulations....................................................................657
Chapter 8—Repeal and transitional provisions 661 66 Transitional arrangements for goods required to be
registered or listed .........................................................661
67 Transitional provision for therapeutic goods for
export only ....................................................................663
68 Transitional arrangements for Part 3-3 ..........................663
69 Continuation of standards and requirements .................664
Endnotes 665
Endnote 1—About the endnotes 665
Endnote 2—Abbreviation key 667
Endnote 3—Legislation history 668
Endnote 4—Amendment history 679
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Preliminary Chapter 1
Section 1
An Act relating to therapeutic goods
Chapter 1—Preliminary
1 Short title
This Act may be cited as the Therapeutic Goods Act 1989.
2 Commencement
This Act commences on the day after the day on which a House of
the Parliament approves regulations made under this Act in the
same form as approved by the other House, provided that:
(a) not more than 90 days have elapsed; and
(b) the places of Senators have not become vacant under section 13
of the Constitution; and
(c) a dissolution or expiration of the House of Representatives
has not occurred;
between the approval of one House and the approval of the other
House.
3 Interpretation
(1) In this Act, unless the contrary intention appears:
accessory, in relation to a medical device covered by
paragraph 41BD(1)(a), (aa) or (ab), means a thing that the
manufacturer of the thing specifically intended to be used together
with the device to enable the device to be used as the manufacturer
of the device intended.
actual or potential tampering has the meaning given by
section 42U.
advertise, in relation to therapeutic goods, includes make any
statement, pictorial representation or design that is intended,
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whether directly or indirectly, to promote the use or supply of the
goods, including where the statement, pictorial representation or
design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the
goods are contained.
anthroposophic pharmacopoeia means:
(a) a publication specified under paragraph 3AB(3)(a), as that
publication is in force from time to time; or
(b) a part of a publication specified under paragraph 3AB(3)(b),
as that part is in force from time to time.
anthroposophic preparation has the meaning given by
subsection 3AB(1).
anthroposophic standard has the meaning given by
subsection 3AB(2).
application audit assessment fee means a fee payable under
subsection 41LA(3).
assessment fee means:
(a) a conformity assessment fee; or
(b) an application audit assessment fee;
payable under Part 4-10.
Australian conformity assessment body means an Australian
corporation that is the subject of a conformity assessment body
determination made under the regulations.
Australian conformity assessment body certificate means a
certificate that is issued by an Australian conformity assessment
body and that is of a kind mentioned in section 41FIA.
Australian corporation means a corporation that is registered
under Part 2A.2 of the Corporations Act 2001.
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authorised person means:
(a) in relation to any provision of this Act or the regulations, a
person authorised by the Secretary to exercise powers under
that provision; or
(b) in relation to a provision of Part 6-2, a member of the
Australian Federal Police, or a Customs officer exercising
powers in a Customs place (within the meaning of
section 183UA of the Customs Act 1901).
batch means a quantity of a product that is:
(a) uniform in composition, method of manufacture and
probability of chemical or microbial contamination; and
(b) made in one cycle of manufacture and, in the case of a
product that is sterilised or freeze dried, sterilised or freeze
dried in one cycle.
bioburden, in relation to therapeutic goods, means the quantity and
characteristics of microorganisms present in the goods or to which
the goods may be exposed in a manufacturing environment.
biological has the meaning given by section 32A.
biological number of a biological means:
(a) the number assigned to the biological under
subsection 32DB(2), 32DF(2) or 32DN(5); or
(b) if, in accordance with regulations made for the purposes of
paragraph 9A(4)(ca), a different number is assigned to the
biological—that different number.
British Pharmacopoeia means the edition of the publication of that
name, including any additions or amendments, that was in effect
for the purposes of this Act immediately before the commencement
of Schedule 4 to the Therapeutic Goods Amendment (Medical
Devices and Other Measures) Act 2009 and, if additions or
amendments of that publication are made after that
commencement, or new editions of that publication are published
after that commencement, includes those additions or amendments,
or those new editions, from the effective date published by the
British Pharmacopoeia Commission or any replacement body.
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certification-related activities, when used in relation to an
Australian conformity assessment body, means activities that
consist of, or relate to, the issue of certificates as mentioned in
section 41FIA.
civil penalty provision has the meaning given by section 42YA.
Class 1 biological means a biological included in a class of
biologicals that is:
(a) a class prescribed by the regulations for the purposes of
section 32AA; and
(b) a class referred to in those regulations as Class 1 biologicals.
Commonwealth authority includes:
(a) a body corporate, or an unincorporated body, established for
a public purpose by or under an Act; and
(b) a tribunal or authority established by or in accordance with
an Act.
Commonwealth officer includes:
(a) a Minister; and
(b) a person holding:
(i) an office established by or under an Act; or
(ii) an appointment made under an Act; or
(iii) an appointment made by the Governor-General or a
Minister but not under an Act; and
(c) a person who is a member or officer of a Commonwealth
authority; and
(d) a person who is in the service or employment of the
Commonwealth, or of a Commonwealth authority, or is
employed or engaged under an Act or regulations made
under an Act.
composite pack has the meaning given by subsection 7B(2).
Comptroller-General of Customs means the person who is the
Comptroller-General of Customs in accordance with
subsection 11(3) or 14(2) of the Australian Border Force Act 2015.
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conformity assessment body determination has the meaning given
by section 41EWA.
conformity assessment certificate means a certificate issued under
section 41EE.
conformity assessment document means:
(a) a conformity assessment certificate; or
(b) an Australian conformity assessment body certificate; or
(c) an overseas regulator conformity assessment document.
conformity assessment fee means a fee payable under
subsection 41LA(1).
conformity assessment procedures has the meaning given by
section 41DA.
conformity assessment standard means a conformity assessment
standard specified in an order under section 41DC.
container, in relation to therapeutic goods, means the vessel,
bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack,
wrapper, cover or other similar article that immediately covers the
goods, but does not include an article intended for ingestion.
corporation means a body corporate that is:
(a) a foreign corporation; or
(b) a trading corporation formed within the limits of the
Commonwealth or a financial corporation so formed.
corresponding State law means a State law declared by the
regulations to correspond to this Act or the regulations, including
such a law as amended from time to time.
counterfeit has the meaning given by section 42E.
current Poisons Standard has the meaning given by section 52A.
Customs officer means an officer of Customs within the meaning
of the Customs Act 1901.
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data processing device means any article or material (for example,
a disc) from which information is capable of being reproduced with
or without the aid of any other article or device.
default standard means any of the following:
(a) a standard referred to in paragraph (b) of the definition of
standard in this subsection;
(b) a standard referred to in paragraph (c) of that definition;
(c) a standard referred to in paragraph (d) of that definition.
device number, in relation to a medical device, means any
combination of numbers, symbols and letters assigned to the device
under section 41FL.
directions for use, in relation to therapeutic goods, includes
information on:
(a) appropriate doses of the goods; and
(b) the method of administration or use of the goods; and
(c) the frequency and duration of treatment for each indication of
the goods; and
(d) the use of the goods by persons of particular ages or by
persons having particular medical conditions.
EC/EFTA attestation of conformity means an attestation of
conformity (within the meaning of the EC Mutual Recognition
Agreement or the EFTA Mutual Recognition Agreement) issued by
an EC/EFTA conformity assessment body that is approved by the
Secretary in writing.
EC/EFTA conformity assessment body means a Conformity
Assessment Body designated in one of the following Sectoral
Annexes to the EC Mutual Recognition Agreement or the EFTA
Mutual Recognition Agreement:
(a) Sectoral Annex (Medical Devices);
(b) Sectoral Annex (Medicinal Products GMP Inspection and
Batch Certification).
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EC Mutual Recognition Agreement means the Agreement on
Mutual Recognition in relation to Conformity Assessment,
Certificates and Markings between Australia and the European
Community, as in force from time to time.
EFTA Mutual Recognition Agreement means the Agreement on
Mutual Recognition in relation to Conformity Assessment,
Certificates and Markings between Australia and the European
Free Trade Association, as in force from time to time.
essential principles has the meaning given by section 41CA.
ethics committee means a committee:
(a) constituted and operating as an ethics committee in
accordance with guidelines issued by the CEO of the
National Health and Medical Research Council as in force
from time to time; and
(b) which has notified its existence to the Australian Health
Ethics Committee established under the National Health and
Medical Research Council Act 1992.
European Pharmacopoeia means the English edition of the
publication of that name, including any additions or amendments,
that was in effect immediately before the commencement of this
definition and, if additions or amendments of that publication are
made after that commencement, or new editions of that publication
are published after that commencement, includes those additions or
amendments, or those new editions, from the effective date
published by the Council of Europe or any replacement body.
exempt device means a medical device that is of a kind that is
exempted from Division 3 of Part 4-11 by the regulations.
exempt goods, in relation to a provision of Part 3-2, means
therapeutic goods that are exempted from the operation of that Part
(except section 31A and sections 31C to 31F) by the regulations.
exempt goods, in relation to a provision of Part 3-3, means
therapeutic goods that are exempted from the operation of that Part
by the regulations.
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exempt person, in relation to therapeutic goods, means a person
exempted from the operation of Part 3-3 in relation to those goods
by the regulations.
export only medicine means a medicine that:
(a) is manufactured in Australia for export only, or imported into
Australia for export only; and
(b) is listable goods only because it is so manufactured or
imported (and not for any other reason).
Federal Circuit Court means the Federal Circuit Court of
Australia.
Federal Court means the Federal Court of Australia.
financial corporation means a financial corporation within the
meaning of paragraph 51(xx) of the Constitution.
first Poisons Standard has the meaning given by section 52A.
foreign corporation means a foreign corporation within the
meaning of paragraph 51(xx) of the Constitution.
gazetted kits group means a group of kits identified in an order in
force under subsection 16(3A).
gazetted therapeutic devices group has the meaning given by
subsection 16(3).
gazetted therapeutic goods group has the meaning given by
subsection 16(2).
Gene Technology Regulator has the same meaning as in the Gene
Technology Act 2000.
genetically modified organism has the same meaning as in the
Gene Technology Act 2000.
GM product has the same meaning as in the Gene Technology Act
2000.
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grouped therapeutic goods means therapeutic goods included in:
(a) a gazetted therapeutic goods group; or
(b) a gazetted therapeutic devices group; or
(c) a gazetted kits group.
health practitioner means a person who, under a law of a State or
internal Territory, is registered or licensed to practice in any of the
following health professions:
(a) Aboriginal and Torres Strait Islander health practice;
(b) dental (not including the professions of dental therapist,
dental hygienist, dental prosthetist or oral health therapist);
(c) medical;
(d) medical radiation practice;
(e) nursing;
(f) midwifery;
(g) occupational therapy;
(h) optometry;
(i) pharmacy;
(j) physiotherapy;
(k) podiatry;
(l) psychology.
homoeopathic pharmacopoeia means:
(a) a publication specified under paragraph 3AA(3)(a), as that
publication is in force from time to time; or
(b) a part of a publication specified under paragraph 3AA(3)(b),
as that part is in force from time to time.
homoeopathic preparation has the meaning given by
subsection 3AA(1).
homoeopathic standard has the meaning given by
subsection 3AA(2).
included in the Register:
(a) in relation to a biological—means included in the Register
under Part 3-2A; and
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(b) in relation to a medical device to which Chapter 4 applies—
means included in the Register under Chapter 4.
Note: Section 41BJ deals with the application of Chapter 4 to medical
devices.
indications, in relation to therapeutic goods, means the specific
therapeutic uses of the goods.
international instrument means:
(a) any treaty, convention, protocol, agreement or other
instrument that is binding in international law; and
(b) a part of such a treaty, convention, protocol, agreement or
other instrument.
kind, in relation to a medical device, has the meaning given by
section 41BE.
label, in relation to therapeutic goods, means a display of printed
information:
(a) on or attached to the goods; or
(b) on or attached to a container or primary pack in which the
goods are supplied; or
(c) supplied with such a container or pack.
licence means a licence under Part 3-3.
listable devices means therapeutic devices that are required to be
included in the part of the Register for listed goods.
listable goods means therapeutic goods that are required:
(a) under the regulations; or
(b) by a notice published in the Gazette or on the Department’s
website under subsection 9A(5);
to be included in the part of the Register relating to listed goods.
listed goods means therapeutic goods that are included in the Part
of the Register for goods known as listed goods.
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listing number, in relation to listed goods, means any combination
of numbers, symbols and letters assigned to the goods under
section 27.
major interest holder of a body corporate means a person who:
(a) is in a position to cast, or control the casting of, more than
one-fifth of the maximum number of votes that might be cast
at a general meeting of the body corporate; or
(b) holds more than one-fifth of the issued share capital of the
body corporate (excluding any part of that issued share
capital that carries no right to participate beyond a specified
amount in a distribution of either profits or capital).
manufacture, in relation to therapeutic goods that are not medical
devices, means:
(a) to produce the goods; or
(b) to engage in any part of the process of producing the goods
or of bringing the goods to their final state, including
engaging in the processing, assembling, packaging, labelling,
storage, sterilising, testing or releasing for supply of the
goods or of any component or ingredient of the goods as part
of that process.
manufacturer, of a medical device, has the meaning given by
section 41BG.
manufacturing principles means the principles for the time being
having effect under section 36.
manufacturing site means premises:
(a) that are for use in the manufacture of a particular kind of
therapeutic goods; and
(b) at which the same persons have control of the management of
the production of the goods and the procedures for quality
control.
manufacturing site authorisation means an authorisation referred
to in subsection 38(2B) or 40B(4).
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medical device has the meaning given by section 41BD.
medical device classification means a classification specified in
the regulations made for the purposes of section 41DB.
medical device standard, in relation to a kind of medical device,
means a medical device standard, specified in an order under
section 41CB, that is applicable to that kind of medical device.
medicine means:
(a) therapeutic goods (other than biologicals) that are represented
to achieve, or are likely to achieve, their principal intended
action by pharmacological, chemical, immunological or
metabolic means in or on the body of a human; and
(b) any other therapeutic goods declared by the Secretary, for the
purpose of the definition of therapeutic device, not to be
therapeutic devices.
member of EFTA means a country declared by the Minister under
section 3A to be a member of the European Free Trade
Association.
member of the European Community means a country declared
by the Minister under section 3A to be a member of the European
Community.
mother substance means any of the following:
(a) an animal;
(b) a plant;
(c) an alga;
(d) a fungus;
(e) a micro-organism;
(f) a mineral;
(g) a mineral compound;
(h) a chemical;
(i) a product obtained from any of the things mentioned in
paragraphs (a) to (h).
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Mutual Recognition Convention means the Convention for the
Mutual Recognition of Inspections in respect of the Manufacture of
Pharmaceutical Products done at Geneva on 8 October 1970.
non-EC/EFTA attestation of conformity, for a non-EC/EFTA
MRA, means an attestation of conformity issued, after the
non-EC/EFTA MRA has come into force, by a conformity
assessment body that is designated in the non-EC/EFTA MRA and
approved by the Secretary in writing for the non-EC/EFTA MRA.
non-EC/EFTA MRA means an international instrument that
Australia is bound by, or is a party to, if:
(a) a purpose of the instrument is the recognition of attestations
of conformity; and
(b) the instrument satisfies the requirements (if any) set out in
regulations made for the purposes of this paragraph;
but does not include:
(c) the EC Mutual Recognition Agreement; or
(d) the EFTA Mutual Recognition Agreement.
oath includes affirmation.
overseas regulator has the meaning given by section 41BIB.
overseas regulator conformity assessment document means a
certificate or other document that is issued by an overseas regulator
after that regulator is satisfied that requirements, comparable to the
conformity assessment procedures, have been applied to a medical
device by the manufacturer of the device.
passed preliminary assessment:
(a) when used in relation to a section 23 application for
registration—has the meaning given by subsection 23B(3);
and
(b) when used in relation to a section 23 application for listing
under section 26AE—has the meaning given by
subsection 23B(3); and
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(c) when used in relation to a section 32DD application—has the
meaning given by subsection 32DDA(3); and
(d) when used in relation to a section 41FC application—has the
meaning given by subsection 41FDB(3).
poison means an ingredient, compound, material or preparation
which, or the use of which, may cause death, illness or injury and
includes any ingredient, compound, material or preparation
referred to in a schedule to the current Poisons Standard.
premises includes:
(a) a structure, building, aircraft, vehicle or vessel; and
(b) a place (whether enclosed or built upon or not); and
(c) a part of a thing referred to in paragraph (a) or (b).
presentation, in relation to therapeutic goods, means the way in
which the goods are presented for supply, and includes matters
relating to the name of the goods, the labelling and packaging of
the goods and any advertising or other informational material
associated with the goods.
primary pack, in relation to therapeutic goods, means the complete
pack in which the goods, or the goods and their container, are to be
supplied to consumers.
product information, in relation to therapeutic goods, means
information relating to the safe and effective use of the goods,
including information regarding the usefulness and limitations of
the goods.
protected information, in relation to therapeutic goods, has the
meaning given by section 25A.
quality, in relation to therapeutic goods, includes the composition,
strength, potency, stability, sterility, purity, bioburden, design,
construction and performance characteristics of the goods.
refurbishment has the meaning given by the regulations.
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Register means the Australian Register of Therapeutic Goods
maintained under section 9A.
registered goods means:
(a) therapeutic goods included in the part of the Register for
goods known as registered goods; or
(b) therapeutic goods included in the part of the Register for
goods known as provisionally registered goods.
Note: Subsection (8) provides that a reference in this Act to therapeutic
goods that are registered, or to the registration of therapeutic goods,
includes a reference to a medicine that is provisionally registered
under section 29.
registration number, in relation to registered goods, means any
combination of numbers, symbols and letters assigned to the goods
under section 27.
related body corporate has the same meaning as in the
Corporations Act 2001.
reportable medicine has the meaning given by section 30EH.
restricted medicine means:
(a) a medicine specified in an instrument under subsection (2A);
or
(b) a medicine included in a class of medicine specified in an
instrument under subsection (2B).
scheduling has the meaning given by section 52A.
Secretary means the Secretary of the Department.
shortage of a medicine in Australia has the meaning given by
section 30EI.
sponsor, in relation to therapeutic goods, means:
(a) a person who exports, or arranges the exportation of, the
goods from Australia; or
(b) a person who imports, or arranges the importation of, the
goods into Australia; or
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(c) a person who, in Australia, manufactures the goods, or
arranges for another person to manufacture the goods, for
supply (whether in Australia or elsewhere);
but does not include a person who:
(d) exports, imports or manufactures the goods; or
(e) arranges the exportation, importation or manufacture of the
goods;
on behalf of another person who, at the time of the exportation,
importation, manufacture or arrangements, is a resident of, or is
carrying on business in, Australia.
standard, in relation to therapeutic goods, means any of the
following:
(a) a standard that is constituted by the matters specified in an
order under section 10 that is applicable to the goods;
(b) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the British Pharmacopoeia—a standard that is constituted by
the statements (other than statements exempt under
subsection 3C(2)) in those monographs, as interpreted in
accordance with the General Notices section of the British
Pharmacopoeia;
(c) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the European Pharmacopoeia—a standard that is constituted
by the statements (other than statements exempt under
subsection 3C(2)) in those monographs, as interpreted in
accordance with the General Notices section of the European
Pharmacopoeia;
(d) if the goods are the subject of one or more monographs
(other than a monograph exempt under subsection 3C(1)) in
the United States Pharmacopeia-National Formulary—a
standard that is constituted by the statements (other than
statements exempt under subsection 3C(2)) in those
monographs, as interpreted in accordance with the General
Notices section of the United States Pharmacopeia-National
Formulary;
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(e) a homoeopathic standard;
(f) an anthroposophic standard.
Note: See also section 13.
State includes the Australian Capital Territory and the Northern
Territory.
State law means a law of a State, of the Australian Capital
Territory or of the Northern Territory.
supply includes:
(a) supply by way of sale, exchange, gift, lease, loan, hire or
hire-purchase; and
(b) supply, whether free of charge or otherwise, by way of
sample or advertisement; and
(c) supply, whether free of charge or otherwise, in the course of
testing the safety or efficacy of therapeutic goods in persons;
and
(d) supply by way of administration to, or application in the
treatment of, a person.
system or procedure pack has the meaning given by section 41BF.
tamper: therapeutic goods are tampered with if:
(a) they are interfered with in a way that affects, or could affect,
the quality, safety or efficacy of the goods; and
(b) the interference has the potential to cause, or is done for the
purpose of causing, injury or harm to any person.
therapeutic device means therapeutic goods (other than
biologicals) consisting of an instrument, apparatus, appliance,
material or other article (whether for use alone or in combination),
together with any accessories or software required for its proper
functioning, which does not achieve its principal intended action
by pharmacological, chemical, immunological or metabolic means
though it may be assisted in its function by such means, but the
expression does not include therapeutic goods declared by the
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Secretary, by order published in the Gazette or on the
Department’s website, not to be therapeutic devices.
therapeutic goods means goods:
(a) that are represented in any way to be, or that are, whether
because of the way in which the goods are presented or for
any other reason, likely to be taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the
manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for goods of
the kind referred to in subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use of which
is, or ordinarily is, a therapeutic use or a use of a kind
referred to in subparagraph (a)(ii) or (iii);
and includes biologicals, medical devices and goods declared to be
therapeutic goods under an order in force under section 7, but does
not include:
(c) goods declared not to be therapeutic goods under an order in
force under section 7; or
(d) goods in respect of which such an order is in force, being an
order that declares the goods not to be therapeutic goods
when used, advertised, or presented for supply in the way
specified in the order where the goods are used, advertised,
or presented for supply in that way; or
(e) goods (other than goods declared to be therapeutic goods
under an order in force under section 7) for which there is a
standard (within the meaning of subsection 4(1) of the Food
Standards Australia New Zealand Act 1991); or
(f) goods (other than goods declared to be therapeutic goods
under an order in force under section 7) which, in Australia
or New Zealand, have a tradition of use as foods for humans
in the form in which they are presented; or
(g) goods covered by a determination under subsection 7AA(1)
(excluded goods); or
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(h) goods covered by a determination under subsection 7AA(2)
(excluded goods), if the goods are used, advertised, or
presented for supply in the way specified in the
determination.
Therapeutic Goods Advertising Code means the code in force
under section 42BAA.
therapeutic use means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease,
ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process
in persons; or
(c) testing the susceptibility of persons to a disease or ailment; or
(d) influencing, controlling or preventing conception in persons;
or
(e) testing for pregnancy in persons; or
(f) the replacement or modification of parts of the anatomy in
persons.
trading corporation means a trading corporation within the
meaning of paragraph 51(xx) of the Constitution.
United States Pharmacopeia-National Formulary means the
English edition of the publication of that name, including any
additions or amendments, that was in effect immediately before the
commencement of this definition and, if additions or amendments
of that publication are made after that commencement, or new
editions of that publication are published after that commencement,
includes those additions or amendments, or those new editions,
from the effective date published by the United States
Pharmacopeial Convention or any replacement body.
working day, for a person, means any day except:
(a) Saturday or Sunday; or
(b) a day that is a public holiday in the State or Territory in
which the person is located.
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(2) For the purposes of this Act, therapeutic goods are taken to be for
use in humans if they are not solely for use in animals.
(2A) The Minister may, by legislative instrument, specify medicines for
the purposes of paragraph (a) of the definition of restricted
medicine in subsection (1).
(2B) The Minister may, by legislative instrument, specify classes of
medicine for the purposes of paragraph (b) of the definition of
restricted medicine in subsection (1).
(3) The Secretary must, at least once in each year, cause to be
published in the Gazette or on the Department’s website a list of
the names of all persons, other than members of the Australian
Federal Police, who are, at the time of publication, authorised
persons.
(4) The provisions of this Act are in addition to, and not in substitution
for, the provisions of any other Act that relate to therapeutic goods.
(5) For the purposes of this Act, the presentation of therapeutic goods
is unacceptable if it is capable of being misleading or confusing as
to the content or proper use or identification of the goods and,
without limiting the previous words in this subsection, the
presentation of therapeutic goods is unacceptable:
(a) if it states or suggests that the goods have ingredients,
components or characteristics that they do not have; or
(b) if a name applied to the goods is the same as the name
applied to other therapeutic goods that are supplied in
Australia where those other goods contain additional or
different therapeutically active ingredients; or
(c) if the label of the goods does not declare the presence of a
therapeutically active ingredient; or
(ca) if the therapeutic goods are medicine included in a class of
medicine prescribed by the regulations for the purposes of
this paragraph—if the medicine’s label does not contain the
advisory statements specified under subsection (5A) in
relation to the medicine; or
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(d) if a form of presentation of the goods may lead to unsafe use
of the goods or suggests a purpose that is not in accordance
with conditions applicable to the supply of the goods in
Australia; or
(e) in prescribed cases.
(5A) The Minister may, by legislative instrument, specify advisory
statements in relation to medicine for the purposes of
paragraph (5)(ca).
(5B) For the purposes of subsection (5A), the Minister may specify
different advisory statements for different medicines or different
classes of medicine.
(6) A reference in this Act to an annual registration charge, an annual
listing charge, an annual charge for inclusion in the Register, an
annual licensing charge or an annual conformity assessment body
determination charge is a reference to such a charge imposed under
the Therapeutic Goods (Charges) Act 1989.
(7) A reference to an offence against this Act includes a reference to:
(a) an offence against the regulations; and
(b) an offence against section 6 of the Crimes Act 1914, or
section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to
an offence against this Act or the regulations; and
(c) an offence against section 136.1, 137.1 or 137.2 of the
Criminal Code in relation to this Act or the regulations.
(7A) For the purposes of this Act, a corresponding State law imposes a
duty on a Commonwealth officer or Commonwealth authority if:
(a) the corresponding State law confers a function or power on
the officer or authority; and
(b) the circumstances in which the function or power is
conferred give rise to an obligation on the officer or authority
to perform the function or to exercise the power.
(8) To avoid doubt:
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(a) a reference in this Act to therapeutic goods that are registered
includes a reference to a medicine that is provisionally
registered; and
(b) a reference in this Act to the registration of therapeutic goods
includes a reference to the provisional registration of a
medicine.
Note: Subsection 29(2) deals with the provisional registration of a medicine.
3AA Homoeopathic preparations and homoeopathic standards
Homoeopathic preparation
(1) For the purposes of this Act, a homoeopathic preparation is a
preparation:
(a) manufactured from a mother substance; and
(b) manufactured in accordance with a manufacturing procedure
described in a homoeopathic pharmacopoeia.
Homoeopathic standard
(2) For the purposes of this Act, if:
(a) there are therapeutic goods that are a homoeopathic
preparation; and
(b) the goods are the subject of one or more monographs (other
than a monograph exempt under subsection (4)) in the
homoeopathic pharmacopoeia describing the manufacturing
procedure that the preparation was manufactured in
accordance with;
then there is a homoeopathic standard, in relation to the goods,
that is constituted by the statements (other than statements exempt
under subsection (5)) in those monographs, as interpreted in
accordance with any interpretation sections of that homoeopathic
pharmacopoeia.
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Specifying publications
(3) The Minister may, by legislative instrument, specify either or both
of the following for the purposes of the definition of homoeopathic
pharmacopoeia in subsection 3(1):
(a) publications;
(b) parts of publications.
Exempting entire monographs
(4) The Minister may, by legislative instrument, determine that
specified monographs in a specified homoeopathic pharmacopoeia
are exempt for the purposes of paragraph (2)(b).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(5) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in a specified
homoeopathic pharmacopoeia are exempt for the purposes of
subsection (2).
3AB Anthroposophic preparations and anthroposophic standards
Anthroposophic preparation
(1) For the purposes of this Act, an anthroposophic preparation is a
preparation:
(a) manufactured from a mother substance; and
(b) manufactured in accordance with a manufacturing procedure
described in an anthroposophic pharmacopoeia.
Anthroposophic standard
(2) For the purposes of this Act, if:
(a) there are therapeutic goods that are an anthroposophic
preparation; and
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(b) the goods are the subject of one or more monographs (other
than a monograph exempt under subsection (4)) in the
anthroposophic pharmacopoeia describing the manufacturing
procedure that the preparation was manufactured in
accordance with;
then there is an anthroposophic standard, in relation to the goods,
that is constituted by the statements (other than statements exempt
under subsection (5)) in those monographs, as interpreted in
accordance with any interpretation sections of that anthroposophic
pharmacopoeia.
Specifying publications
(3) The Minister may, by legislative instrument, specify either or both
of the following for the purposes of the definition of
anthroposophic pharmacopoeia in subsection 3(1):
(a) publications;
(b) parts of publications.
Exempting entire monographs
(4) The Minister may, by legislative instrument, determine that
specified monographs in a specified anthroposophic
pharmacopoeia are exempt for the purposes of paragraph (2)(b).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(5) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in a specified
anthroposophic pharmacopoeia are exempt for the purposes of
subsection (2).
3A Declaration—member of European Community
(1) The Minister may declare, in writing, that a country specified in
the declaration is a member of:
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(a) the European Community; or
(b) the European Free Trade Association.
(2) A declaration under subsection (1) must be published in the
Gazette or on the Department’s website.
3B Declaration—country covered by non-EC/EFTA MRA
(1) The Minister may declare, in writing, that a country specified in
the declaration is covered by the non-EC/EFTA MRA specified in
the declaration.
(2) A declaration under subsection (1) must be published in the
Gazette or on the Department’s website.
3C Exempting monographs in pharmacopoeias
Exempting entire monographs
(1) The Minister may, by legislative instrument, determine that
specified monographs in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary are exempt for the purposes of paragraph (b), (c) or (d)
of the definition of standard in subsection 3(1).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
Exempting parts of monographs
(2) The Minister may, by legislative instrument, determine that
specified statements in specified monographs in the British
Pharmacopoeia, the European Pharmacopoeia or the United States
Pharmacopeia-National Formulary are exempt for the purposes of
paragraph (b), (c) or (d) of the definition of standard in
subsection 3(1).
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4 Objects of Act
(1) The objects of this Act are to do the following, so far as the
Constitution permits:
(a) provide for the establishment and maintenance of a national
system of controls relating to the quality, safety, efficacy and
timely availability of therapeutic goods that are:
(i) used in Australia, whether produced in Australia or
elsewhere; or
(ii) exported from Australia;
(b) to provide a framework for the States and Territories to adopt
a uniform approach to control the availability and
accessibility, and ensure the safe handling, of poisons in
Australia.
(1A) The reference in paragraph (1)(a) to the efficacy of therapeutic
goods is a reference, if the goods are medical devices, to the
performance of the devices as the manufacturer intended.
(2) This Act is therefore not intended to apply to the exclusion of a law
of a State, of the Australian Capital Territory or of the Northern
Territory to the extent that the law is capable of operating
concurrently with this Act.
5 Act to bind Crown
This Act binds the Crown in right of the Commonwealth, of each
of the States, of the Australian Capital Territory and of the
Northern Territory, but nothing in this Act renders the Crown
liable to be prosecuted for an offence or to be subject to civil
proceedings for a contravention of a civil penalty provision.
5A Application of the Criminal Code—extended geographical
jurisdiction
Section 15.2 of the Criminal Code (extended geographical
jurisdiction—category B) applies to offences against
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subsections 21A(1), (4) and (4A) and sections 22A, 32DO, 41FE,
42E and 42T.
6 Operation of Act
(1) This Act applies to:
(a) things done by corporations; and
(b) things done by natural persons or corporations in so far as
those things are done:
(i) in the course of, or in preparation for, trade or
commerce between Australia and a place outside
Australia, among the States, between a State and a
Territory or between 2 Territories; or
(ii) under a law of the Commonwealth relating to the
provision of pharmaceutical or repatriation benefits; or
(iii) in relation to the Commonwealth or in relation to an
authority of the Commonwealth.
(2) Without limiting the effect of this Act apart from this subsection,
this Act also has the effect it would have if the reference in
paragraph (1)(a) to things done by corporations were confined to
things done by trading corporations for the purposes of their
trading activities.
6AAA Commonwealth consent to conferral of functions etc. on its
officers and authorities by corresponding State laws
(1) A corresponding State law may confer functions or powers, or
impose duties, on:
(a) a Commonwealth officer; or
(b) a Commonwealth authority.
(2) Subsection (1) does not authorise the conferral of a function or
power, or the imposition of a duty, by a corresponding State law to
the extent to which:
(a) the conferral or imposition, or the authorisation, would
contravene any constitutional doctrines restricting the duties
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that may be imposed on Commonwealth officers or
Commonwealth authorities; or
(b) the authorisation would otherwise exceed the legislative
power of the Commonwealth.
(3) Subsection (1) does not extend to a function, power or duty of a
kind specified in regulations made for the purposes of this
subsection.
(4) This Act is not intended to exclude or limit the operation of a
corresponding State law that confers any functions or powers, or
imposes any duties, on a Commonwealth officer or
Commonwealth authority to the extent to which that law:
(a) is consistent with subsections (1) to (3); and
(b) is capable of operating concurrently with this Act.
6AAB When duty imposed
Application
(1) This section applies if a corresponding State law purports to
impose a duty on a Commonwealth officer or Commonwealth
authority.
State legislative power sufficient to support duty
(2) The duty is taken not to be imposed by this Act (or any other law
of the Commonwealth) to the extent to which:
(a) imposing the duty is within the legislative powers of the State
concerned; and
(b) imposing the duty by the corresponding State law is
consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
Note: If this subsection applies, the duty will be taken to be imposed by
force of the corresponding State law (the Commonwealth having
consented under section 6AAA to the imposition of the duty by the
corresponding State law).
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Commonwealth legislative power sufficient to support duty but
State legislative powers are not
(3) If, to ensure the validity of the purported imposition of the duty, it
is necessary that the duty be imposed by a law of the
Commonwealth (rather than by force of the corresponding State
law), the duty is taken to be imposed by this Act to the extent
necessary to ensure that validity.
(4) If, because of subsection (3), this Act is taken to impose the duty, it
is the intention of the Parliament to rely on all powers available to
it under the Constitution to support the imposition of the duty by
this Act.
(5) The duty is taken to be imposed by this Act in accordance with
subsection (3) only to the extent to which imposing the duty:
(a) is within the legislative powers of the Commonwealth; and
(b) is consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
(6) To avoid doubt, neither this Act (nor any other law of the
Commonwealth) imposes a duty on the Commonwealth officer or
Commonwealth authority to the extent to which imposing such a
duty would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative power of the
Commonwealth.
(7) Subsections (1) to (6) do not limit section 6AAA.
6AAC Imposing duty under State law
(1) This section:
(a) applies only for the purposes of the application of the
provisions of this Act or another law of the Commonwealth
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(with or without modification) as a law of a State by a
provision of a corresponding State law; and
(b) does not apply for those purposes if the corresponding State
law otherwise provides.
(2) If the corresponding State law purports to impose a duty on a
Commonwealth officer or Commonwealth authority to do a
particular thing, the duty is taken to be imposed by the
corresponding State law to the extent to which imposing the duty:
(a) is within the legislative powers of the State; and
(b) is consistent with the constitutional doctrines restricting the
duties that may be imposed on a Commonwealth officer or
Commonwealth authority.
(3) To avoid doubt, the corresponding State law does not impose the
duty on the Commonwealth officer or Commonwealth authority to
the extent to which imposing the duty would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative powers of the State.
(4) If imposing on the Commonwealth officer or Commonwealth
authority the duty to do that thing would:
(a) contravene any constitutional doctrine restricting the duties
that may be imposed on a Commonwealth officer or
Commonwealth authority; or
(b) otherwise exceed the legislative powers of both the State and
the Commonwealth;
the corresponding State law is taken instead to confer on the officer
or authority a power to do that thing at the discretion of the officer
or authority.
6AAD Conferral of jurisdiction on federal courts
If:
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(a) a provision of a corresponding State law purports to apply a
provision of a law of the Commonwealth (the applied
provision) as a law of the State; and
(b) the applied provision purports to confer jurisdiction in
relation to a matter on a federal court;
the jurisdiction in relation to that matter is taken to be conferred on
the court by this section.
6AAE Consequences of State law conferring duty, function or power
on Commonwealth officer or Commonwealth authority
(1) If a corresponding State law confers on a Commonwealth officer or
Commonwealth authority:
(a) the function of including goods in the Register; or
(b) the power to include goods in the Register;
the officer or authority may include the goods in the Register in
accordance with the corresponding State law.
(2) If a corresponding State law authorises or requires a
Commonwealth officer or Commonwealth authority to cancel the
inclusion of goods in the Register, the officer or authority may
cancel the inclusion of the goods in the Register in accordance with
the corresponding State law.
(3) The inclusion of goods in the Register under subsection (1) does
not subject any person to any liability whatever under this Act,
except a liability under Part 6-1.
(4) A Commonwealth officer or Commonwealth authority may make
any notations in the Register that the officer or authority considers
necessary to identify entries that relate to goods included in the
Register under subsection (1).
(5) Goods may be included in the Register under subsection (1) even
though the same goods have already been included in the Register
under another provision of this Act.
(6) A reference in this section to the inclusion of goods in the Register
is a reference to the inclusion of the goods:
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(a) in the part of the Register for goods known as registered
goods; or
(aa) in the part of the Register for goods known as provisionally
registered goods; or
(b) in the part of the Register for goods known as listed goods; or
(ba) in the part of the Register for biologicals included under
Part 3-2A; or
(c) in the part of the Register for medical devices included under
Chapter 4.
6B Review of certain decisions under State laws
(1) Application may be made to the Administrative Appeals Tribunal
for review of a reviewable State decision.
(2) A decision made by the Secretary in the performance of a function,
or the exercise of a power, conferred by a corresponding State law
is a reviewable State decision for the purpose of this section if:
(a) the law under which the decision was made provides for
review by the Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable
decision for the purposes of this section.
(3) For the purposes of subsection (1), the Administrative Appeals
Tribunal Act 1975 has effect as if a corresponding State law were
an enactment.
6C Fees payable to Commonwealth under State laws
(1) This section applies to fees payable to the Commonwealth under a
State law in respect of the performance or exercise of functions or
powers conferred by that law on the Secretary.
(2) The Secretary may make arrangements with the appropriate
authority of a State, of the Australian Capital Territory or of the
Northern Territory in relation to the payment to the
Commonwealth of fees to which this section applies.
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7 Declaration that goods are/are not therapeutic goods
(1) Where the Secretary is satisfied that particular goods or classes of
goods:
(a) are or are not therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular
way, are or are not therapeutic goods;
the Secretary may, by order published in the Gazette or on the
Department’s website, declare that the goods, or the goods when
used, advertised, or presented for supply in that way, are or are not,
for the purposes of this Act, therapeutic goods.
(1A) In deciding whether particular goods or classes of goods:
(a) are therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular
way, are therapeutic goods;
the Secretary must disregard paragraphs (e) and (f) of the definition
of therapeutic goods in subsection 3(1).
(2) The Secretary may exercise his or her powers under this section of
his or her own motion or following an application made in writing
to the Secretary.
(3) A declaration under this section takes effect on the day on which
the declaration is published in the Gazette or on the Department’s
website or on such later day as is specified in the order.
(4) If a declaration under this section:
(a) is a declaration that particular goods or classes of goods are
not therapeutic goods; and
(b) applies wholly or partly to goods that, apart from this section,
would be medical devices;
the goods are not medical devices, or are not medical devices when
used, advertised, or presented for supply in the way specified in the
declaration.
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7AA Excluded goods
(1) The Minister may, by legislative instrument, determine that
specified goods (other than goods declared to be therapeutic goods
under an order in force under section 7) are excluded goods for the
purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(2) The Minister may, by legislative instrument, determine that
specified goods (other than goods declared to be therapeutic goods
under an order in force under section 7), when used, advertised, or
presented for supply in a way specified in the determination, are
excluded goods for the purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) Before making a determination under this section, the Minister
must have regard to the following matters:
(a) whether it is likely that the specified goods, if not regulated
under this Act, might harm the health of members of the
public;
(b) whether it is appropriate in all the circumstances to apply the
national system of controls relating to the quality, safety,
efficacy and performance of therapeutic goods established by
this Act to regulate the specified goods;
(c) whether the kinds of risks from the specified goods to which
members of the public might be exposed could be more
appropriately dealt with under another regulatory scheme.
(4) The Minister may have regard to any other matter he or she
considers relevant.
7A Authorised persons
The Secretary may, in writing, authorise any of the following
persons to exercise powers under a specified provision of this Act:
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(a) an officer of the Department, of another Department or of an
authority of the Commonwealth;
(b) an officer of:
(i) a Department of State of a State; or
(ii) a Department or administrative unit of the Public
Service of a Territory; or
(iii) an authority of a State or of a Territory;
being a Department, unit or authority that has functions
relating to health matters or law enforcement matters.
7B Kits
(1) If a package contains one or more goods, the package and each of
the goods in the package together constitute a kit for the purposes
of this Act if:
(a) the package and each of the goods are for use as a unit; and
(b) the package and the goods do not constitute a composite pack
or a system or procedure pack; and
(c) at least one of the goods is therapeutic goods; and
(d) each item of the therapeutic goods consists of goods that are:
(i) registered or listed; or
(ii) exempt goods in relation to Part 3-2; or
(iii) included in the Register under Part 3-2A; or
(iv) exempt under subsection 32CA(2) or section 32CB.
(2) A package and therapeutic goods in the package together constitute
a composite pack if:
(a) the therapeutic goods are of 2 or more kinds; and
(b) the package does not contain any medical devices or
therapeutic devices; and
(c) the therapeutic goods are for administration as a single
treatment or as a single course of treatment; and
(d) it is necessary that the therapeutic goods be combined before
administration or that they be administered in a particular
sequence.
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(3) To avoid doubt, it is declared that a kit constitutes therapeutic
goods.
7C Secretary may arrange for use of computer programs to make
decisions
(1) The Secretary may arrange for the use, under the Secretary’s
control, of computer programs for any purposes for which the
Secretary may make decisions under this Act or the regulations.
(2) A decision made by the operation of a computer program under
such an arrangement is taken to be a decision made by the
Secretary.
(3) The Secretary may substitute a decision (the substituted decision)
for a decision (the initial decision) made by the operation of a
computer program under such an arrangement if the Secretary is
satisfied that the initial decision is incorrect.
(4) However, the substituted decision may only be made before the
end of the period of 60 days beginning on the day the initial
decision is made.
7D Form for product information for medicine
(1) The Secretary may, by writing, approve a form for product
information in relation to medicine.
(2) The Secretary may approve different forms for different medicines
or different classes of medicine.
8 Power to obtain information with respect to therapeutic goods
(1) The Secretary may, by notice in writing given to a person who has
imported into Australia or has supplied in Australia:
(a) therapeutic goods; or
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(b) goods in relation to which the Secretary is considering
making a declaration under section 7; or
(c) goods in relation to which the Minister is considering making
a determination under section 7AA (excluded goods);
request the person to give to an officer of the Department identified
in the notice, within such reasonable period as is specified in the
notice, information required by the notice concerning the
composition, indications, directions for use or labelling of the
goods or concerning advertising material relating to the goods.
(1A) A notice under subsection (1) may require the information to be
given:
(a) in writing; or
(b) in accordance with specified software requirements:
(i) on a specified kind of data processing device; or
(ii) by way of a specified kind of electronic transmission.
(2) A person must not fail to comply with a notice given to the person
under this section.
Penalty: 60 penalty units.
(3) Subsection (2) does not apply if the person has a reasonable
excuse.
Note: The defendant bears an evidential burden in relation to the matter in
subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) An offence under subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
9 Arrangements with States etc.
(1) The Minister may make arrangements with the appropriate
Minister of a State, of the Australian Capital Territory or of the
Northern Territory for the carrying out by that State or Territory,
on behalf of the Commonwealth, of:
(a) the evaluation of therapeutic goods for registration; or
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(aa) the evaluation of a biological, other than a Class 1 biological,
for inclusion in the Register under Part 3-2A; or
(b) the inspection of manufacturers of therapeutic goods; or
(c) other functions under this Act or the regulations.
(2) An arrangement under this section may provide for the payment to
a State or Territory of amounts in respect of the performance of
functions under the arrangement.
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Chapter 2—Australian Register of
Therapeutic Goods
9A Australian Register of Therapeutic Goods
(1) The Secretary is to cause to be maintained a register, to be known
as the Australian Register of Therapeutic Goods, for the purpose of
compiling information in relation to, and providing for evaluation
of, therapeutic goods for use in humans.
(2) Subject to subsection (3), the Register is to be kept in such form as
the Secretary determines.
(3) The Register is to contain these 5 parts:
(a) a part for goods to be known as registered goods; and
(aa) a part for goods to be known as provisionally registered
goods; and
(b) a part for goods to be known as listed goods; and
(ba) a part for biologicals included in the Register under
Part 3-2A; and
(c) a part for medical devices included in the Register under
Chapter 4.
(4) The regulations may prescribe:
(a) the therapeutic goods, or the classes of therapeutic goods,
that are required to be included in each part of the Register;
and
(b) the ways in which goods that are included in one part of the
Register may be transferred, or may be required to be
transferred, to another part of the Register; and
(c) the ways in which goods that have been assigned a
registration or listing number may be assigned a different
registration or listing number; and
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(ca) the ways in which a biological that has been assigned a
number under subsection 32DB(2), 32DF(2) or 32DN(5) may
be assigned a different number (which may be any
combination of numbers and either or both of letters and
symbols); and
(d) the ways in which medical devices that have been assigned a
device number may be assigned a different device number.
(5) The Minister may, by notice published in the Gazette or on the
Department’s website:
(a) require that specified therapeutic goods be included in the
part of the Register for listed goods; and
(b) specify the conditions subject to which such goods may be
included in that part of the Register.
(6) If the regulations are amended to require any of those goods to be
included in the part of the Register for listed or registered goods,
then the notice ceases to have effect in respect of the goods
included in the regulations.
9B When registrations or listings of medical devices are taken to be
cancelled
(1) The registration or listing of a medical device to which
subsection 15A(5) applied is taken to be cancelled:
(a) on the second anniversary of the day on which Chapter 4
commences; or
(b) if the medical device is of a kind included in the Register
under Chapter 4 before that second anniversary—when that
inclusion takes effect.
(2) The registration or listing of any other medical device is taken to
be cancelled at the time shown in the table:
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Time of cancellation of registration or listing
Circumstances Time
1 That kind of medical device is When that kind of medical device is included
included in the Register under in the Register under Chapter 4
Chapter 4 before 4 October 2007
because of an application finally
determined before that day
2 An effective application for a The end of 30 days after the application is
conformity assessment finally determined or, if the application
certificate relating to that kind of lapses, the later of the following times (or
medical device is made, but not either of them if they are the same):
finally determined, before
4 October 2007 (a) the time the application lapses;
(b) the start of 4 October 2007
3 An effective application to Whichever one of the following times
include that kind of medical applies, or the earlier of them:
device in the Register under
Chapter 4 is made, but not
finally determined, before
4 October 2007, and item 2 does
(a) the time that kind of medical device is
included in the Register under Chapter 4
(even if that time is before 4 October
2007); not apply (b) the time the application is finally
determined, if the application is
unsuccessful when it is finally
determined;
or, if the application lapses, the later of the
following times (or either of them if they are
the same):
(c) the time the application lapses;
(d) the start of 4 October 2007
None of items 1, 2 and 3 applies The start of 4 October 2007
Note: 4 October 2007 is the fifth anniversary of the day Chapter 4
commenced.
(2A) For the purposes of subsection (2), an application is finally
determined at the first time both the following conditions are met:
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(a) a decision has been made under Part 4-4 or 4-5 whether or
not to grant the conformity assessment certificate or include
the kind of medical device in the Register (as appropriate);
(b) there is no longer any possibility of a change in the outcome
of the decision in terms of the grant (or not) of the
conformity assessment certificate or the inclusion (or not) of
the kind of medical device in the Register.
For the purposes of paragraph (b), ignore any possibility of a
discretion being exercised, after the period has ended, to extend a
period for seeking review by a tribunal or court of the decision or
for starting other proceedings (including appeals) arising out of the
application, the decision or the review.
Note: In certain circumstances a decision may be taken to have been made
under Part 4-4 or Part 4-5. For example, see section 41EH.
(3) This section does not prevent the Secretary from taking action
under section 30.
9C Inspection of entries in Register
(1) A person in relation to whom therapeutic goods are entered on the
Register may make a written request to the Secretary for a copy of
the entry in the Register in relation to the goods.
(2) If the person makes such a request, the Secretary must send to the
person a copy of so much (if any) of that entry as is contained in
any computer database maintained by the Department for purposes
connected with the administration of this Act (other than any part
of that entry that was supplied in confidence by another person).
(3) If the person makes such a request, then, instead of providing a
copy of an entry to the person, the Secretary may, if the request is
for the provision of an electronic copy, provide the information
contained in the entry:
(a) on a data processing device; or
(b) by way of electronic transmission.
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9D Variation of entries in Register
(1) The Secretary may:
(a) following a request by a person in relation to whom
therapeutic goods are entered on the Register; or
(b) on the Secretary’s own initiative;
vary the entry in the Register in relation to the goods if the entry
contains information that is incomplete or incorrect.
(1A) If:
(a) a medicine is included in the part of the Register for goods
known as provisionally registered goods; and
(b) it appears to the Secretary that the quality, safety or efficacy
of the medicine is unacceptable in relation to a class of
persons;
the Secretary may, on the Secretary’s own initiative, vary the entry
in the Register in relation to the medicine:
(c) to reduce the class of persons for whom the medicine is
suitable or to change the directions for use; or
(d) to add a warning, or precaution, that does not include any
comparison of the medicine with any other medicine by
reference to quality, safety or efficacy.
Note: The Secretary may also vary the product information relating to the
medicine: see subsection 25AA(4).
(1B) If:
(a) a medicine is included in the part of the Register for goods
known as provisionally registered goods; and
(b) the Secretary makes a decision under subsection 29(9) to
extend the provisional registration period for the medicine;
the Secretary may, on the Secretary’s own initiative, vary the entry
in the Register in relation to the medicine to reduce the class of
persons for whom the medicine is suitable or to change the
directions for use.
Note: The Secretary may also vary the product information relating to the
medicine: see subsection 25AA(4).
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(1C) If the Secretary proposes to make a variation under subsection (1A)
or (1B), the Secretary must:
(a) give the person in relation to whom the medicine is registered
written notice of the proposed variation and of the reasons for
the proposed variation; and
(b) give the person a reasonable opportunity to make a
submission to the Secretary in relation to the proposed
variation; and
(c) if the person makes a submission in accordance with
paragraph (b)—take the submission into account before
making a decision whether or not to make the variation.
(1D) Subsections (1A) and (1B) apply despite subsection 16(1).
(2) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary
information included in the entry in the Register that relates
to the goods; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the goods are
suitable; or
(ii) to add a warning, or precaution, that does not include
any comparison of the goods with any other therapeutic
goods by reference to quality, safety or efficacy;
the Secretary must vary the entry in accordance with the request.
(2A) Subsection (2), to the extent to which it relates to
subparagraph (2)(b)(i), applies despite subsection 16(1).
(2C) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary the
entry in the Register that relates to the goods; and
(b) the variation is of a kind specified in the regulations; and
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(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(2D) Subsection (2C), to the extent that it relates to therapeutic goods
that are registered, applies despite subsection 16(1).
(3) If:
(a) the person in relation to whom therapeutic goods are
registered or listed has requested the Secretary to vary
information included in the entry in the Register that relates
to the goods; and
(b) subsection (2) does not apply to the request; and
(ba) subsection (2C) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the
goods for the purposes for which they are to be used;
the Secretary may vary the entry in accordance with the request.
(3AA) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary information
included in the entry in the Register that relates to the
biological; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the biological is
suitable; or
(ii) to add a warning, or precaution, that does not include
any comparison of the biological with any other
therapeutic goods by reference to quality, safety or
efficacy;
the Secretary must vary the entry in accordance with the request.
(3AC) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary the entry in the
Register that relates to the biological; and
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(b) the variation is of a kind specified in the regulations; and
(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(3A) If:
(a) the person in relation to whom a biological is included in the
Register has requested the Secretary to vary information
included in the entry in the Register that relates to the
biological; and
(aa) subsection (3AA) does not apply to the request; and
(ab) subsection (3AC) does not apply to the request; and
(b) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the
biological for the purposes for which it is to be used;
the Secretary may vary the entry in accordance with the request.
(3B) If:
(a) a particular biological ceases to be a biological because of a
determination under subsection 32A(3); and
(b) the biological is included in the Register under Part 3-2A;
the Secretary must move the entry relating to the biological from
the part of the Register for biologicals to whichever other part of
the Register is applicable.
(3C) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
information included in the entry in the Register that relates
to the kind of medical device; and
(b) the only effect of the variation would be:
(i) to reduce the class of persons for whom the kind of
medical device is suitable; or
(ii) to add a warning, restriction or precaution, that does not
include any comparison of the kind of medical device
with any other therapeutic goods by reference to quality,
safety or performance;
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the Secretary must vary the entry in accordance with the request.
(3CB) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
the entry in the Register that relates to the kind of medical
device; and
(b) the variation is of a kind specified in the regulations; and
(c) the conditions (if any) specified in the regulations are
satisfied;
the Secretary must vary the entry in accordance with the request.
(3D) If:
(a) the person in relation to whom a kind of medical device is
included in the Register has requested the Secretary to vary
information included in the entry in the Register that relates
to the kind of medical device; and
(b) subsection (3C) does not apply to the request; and
(ba) subsection (3CB) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or performance
of the kind of medical device for the purposes for which it is
to be used;
the Secretary may vary the entry in accordance with the request.
(4) If:
(a) particular therapeutic goods cease to be medical devices
because of a declaration under subsection 41BD(3); and
(b) those goods are included in the Register under Chapter 4 as a
kind of medical device;
the Secretary must move the entry relating to the goods from the
part of the Register for medical devices to whichever other part of
the Register is applicable.
Note: Variations to the Register also occur to give effect to limited
cancellations of entries of kinds of medical devices from the Register:
see subsection 41GO(2).
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Section 9E
Form and manner of requests
(6) The Secretary may, by writing:
(a) approve a form for particular kinds of requests under this
section; and
(b) approve the manner of making particular kinds of requests
under this section.
(7) If:
(a) the Secretary has approved a form for, and the manner of
making, a kind of request under this section; and
(b) either:
(i) the kind of request is one under subsection (3) and
which, under the regulations, must be decided within
175 or 255 working days; or
(ii) the kind of request is one prescribed by the regulations
for the purposes of this subparagraph;
then a request of that kind is not effective unless:
(c) the request is in accordance with that form; and
(d) the request contains the information required by that form;
and
(e) the request is made in that manner; and
(f) any prescribed application fee has been paid; and
(g) the request is accompanied by information that is:
(i) of a kind determined under subsection (8); and
(ii) in a form approved, in writing, by the Secretary.
(8) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of subparagraph (7)(g)(i).
Note: See also subsection 33(3A) of the Acts Interpretation Act 1901.
9E Publication of list of goods on Register
The Secretary must, at least once every 12 months, publish a list of
the therapeutic goods included in the Register.
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9F Removal of entries from Register
(1) This section applies if:
(a) there is an entry on the Register in relation to goods; and
(b) the Secretary is satisfied that the goods are not therapeutic
goods.
(2) The Secretary may, by written notice given to the person in relation
to whom the goods are entered on the Register, remove the entry of
the goods from the Register.
(3) Before removing the entry, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
removal and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed removal within the
period specified in the notice (being not less than 20 working
days after the day the notice is given).
(4) The Secretary must not give the person a notice under
subsection (2) until the Secretary has had regard to any
submissions the person makes under paragraph (3)(b).
(5) A notice under subsection (2) is not a legislative instrument.
(6) If the Secretary removes an entry of goods from the Register under
this section, the removal has effect on the day specified in the
notice under subsection (2) in relation to the goods, being a day not
earlier than 20 working days after the day on which the notice is
given to the person.
(7) If the Secretary removes an entry of goods from the Register under
this section, the Secretary must, as soon as practicable after the
removal, cause to be published in the Gazette, or on the
Department’s website, a notice setting out particulars of the
removal.
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Section 9G
9G Criminal offences for false statements in requests for variation of
entries in Register
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a request
under section 9D for the variation of an entry in the Register
in relation to therapeutic goods; and
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(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
9H Civil penalty for false statements in requests for variation of
entries in Register
A person contravenes this section if the person in or in connection
with a request under section 9D for the variation of an entry in the
Register in relation to therapeutic goods, makes a statement that is
false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 10
Chapter 3—Medicines and other therapeutic
goods that are not medical devices Note: This Chapter still applies to medical devices while they are registered or listed goods.
Section 9B automatically cancels the registration or listing of those goods over time.
Part 3-1—Standards
10 Determination of standards
(1) The Minister may, by legislative instrument, make an order
determining that matters specified in the order constitute a standard
for therapeutic goods or a class of therapeutic goods identified in
the order (whether or not those goods are the subject of a
monograph in the British Pharmacopoeia, the European
Pharmacopoeia, the United States Pharmacopeia-National
Formulary, a homoeopathic pharmacopoeia or an anthroposophic
pharmacopoeia).
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) Without limiting the generality of subsection (1), an order
establishing a standard for therapeutic goods may:
(a) be specified by reference to:
(i) the quality of the goods; or
(ii) the quantity of the goods when contained in specified
containers; or
(iii) procedures to be carried out in the manufacture of the
goods; or
(iv) a monograph in the British Pharmacopoeia, the
European Pharmacopoeia, the United States
Pharmacopeia-National Formulary, a homoeopathic
pharmacopoeia or an anthroposophic pharmacopoeia; or
(v) a monograph in another publication approved by the
Minister for the purposes of this subsection; or
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(vi) such a monograph as modified in a manner specified in
the order establishing the standard; or
(vii) a standard published by Standards Australia; or
(viii) such other matters as the Minister thinks fit; or
(b) require that a matter relating to the standard be determined in
accordance with a particular test; or
(c) require that therapeutic goods or a class of therapeutic goods
identified in the order be labelled or packaged in a manner, or
kept in containers that comply with requirements, specified
in the order.
(3) Without limiting the generality of paragraph (2)(c), the Minister
may, in an order establishing a standard, direct that there be set out,
in a manner specified in the order, on:
(a) therapeutic goods or a class of therapeutic goods identified in
the order; or
(b) a container or package containing therapeutic goods or a
class of therapeutic goods identified in the order; or
(c) a label of therapeutic goods or a class of therapeutic goods
identified in the order;
such particulars as are required by the order.
(3A) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(4) Despite subsection 14(2) of the Legislation Act 2003, an order
under subsection (1) of this section, or a variation of such an order,
may make provision in relation to a matter by applying, adopting
or incorporating, with or without modification, any matter
contained in an instrument or other writing as in force or existing
from time to time.
10A Application of standards to medical devices
A standard under section 10 does not apply to a medical device
unless Part 3-2 applies to the device.
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Section 13
Note: Section 15A sets out when Part 3-2 applies to a medical device.
13 Special provisions relating to Ministerial standards and default
standards
(1) For the purposes of this Act, if a statement (the main statement) in
a monograph in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary refers to a statement in a monograph in another
publication, the main statement is taken to include the other
statement.
(2) If:
(a) a standard under section 10 (the Ministerial standard)
applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in a
default standard; and
(c) those requirements are inconsistent with the requirements
specified in the Ministerial standard;
the requirements referred to in paragraph (b) are, so far as they are
inconsistent, to be disregarded for the purposes of this Act.
(3) If:
(a) a default standard applies to a class of therapeutic goods; and
(b) another default standard applies to only some of the
therapeutic goods within that class; and
(c) those standards are inconsistent;
the standard referred to in paragraph (a) does not apply in relation
to the goods referred to in paragraph (b).
(4) If:
(a) therapeutic goods consist, or are represented to consist, of a
mixture of ingredients or of a combination of component
parts; and
(b) a default standard is applicable to one or more of the
ingredients or one or more of the component parts; and
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(c) a default standard is applicable to the mixture or
combination;
the standard referred to in paragraph (b) does not apply in relation
to the goods.
(5) If:
(a) therapeutic goods consist, or are represented to consist, of a
mixture of ingredients or of a combination of component
parts; and
(b) there is no standard applicable to the mixture or combination
but a standard is applicable to one or more of the ingredients
or one or more of the component parts;
the Minister may, by order published in the Gazette or on the
Department’s website, determine that the standard does not apply
to the goods. The order has effect accordingly.
(6) An order under subsection (5) is not a legislative instrument.
(7) For the purposes of this Act, in working out at a particular time if
therapeutic goods conform with a default standard applicable to the
goods, if:
(a) after applying subsections (2) to (5), 2 or more default
standards are applicable to the goods at that time; and
(b) at that time, the goods conform with at least one of those
standards but do not conform with at least one of those
standards;
then the default standards that the goods do not conform with are
taken not to apply to the goods at that time.
13A Special provisions relating to homoeopathic standards and
anthroposophic standards
(1) For the purposes of this Act, if a statement (the main statement) in
a monograph in a homoeopathic pharmacopoeia or an
anthroposophic pharmacopoeia refers to a statement in a
monograph in another publication, the main statement is taken to
include the other statement.
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(2) If:
(a) a standard under section 10 (the Ministerial standard)
applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in a
homoeopathic standard or an anthroposophic standard; and
(c) those requirements are inconsistent with the requirements
specified in the Ministerial standard;
the requirements referred to in paragraph (b) are, so far as they are
inconsistent, to be disregarded for the purposes of this Act.
14 Criminal offences for importing, supplying or exporting goods
that do not comply with standards
Offences relating to importing goods into Australia
(1) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging); and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are imported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Exception
(5A) Subsection (1), (4) or (4A) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person imports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (5A): see subsection 13.3(3) of the Criminal Code.
Offences relating to supplying goods for use in Australia
(6) A person commits an offence if:
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(a) the person supplies therapeutic goods for use in Australia;
and
(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (9) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(9) A person commits an offence if:
(a) the person supplies therapeutic goods for use in Australia;
and
(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(9AA) A person commits an offence if:
(a) the person supplies therapeutic goods for use in Australia;
and
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(b) the goods are supplied without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Penalty: 100 penalty units.
(9AB) An offence against subsection (9AA) is an offence of strict
liability.
Exception
(9A) Subsection (6), (9) or (9AA) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person supplies the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (9A): see subsection 13.3(3) of the Criminal Code.
Offences relating to exporting goods from Australia
(10) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia); and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the goods
do not conform with the standard.
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Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (13) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(13) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(13AA) A person commits an offence if:
(a) the person exports therapeutic goods from Australia; and
(b) the goods are exported without the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Penalty: 100 penalty units.
(13AB) An offence against subsection (13AA) is an offence of strict
liability.
Exception
(13A) Subsection (10), (13) or (13AA) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person exports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
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Note: A defendant bears an evidential burden in relation to the matter in
subsection (13A): see subsection 13.3(3) of the Criminal Code.
Decisions on whether to give consent
(14) The Secretary must, as soon as practicable after making a decision
to give a consent, cause particulars of the decision to be published
in the Gazette or on the Department’s website.
(15) The Secretary must, within 28 days after making a decision to
refuse to give a consent, notify the applicant in writing of the
decision and of the reasons for the decision.
14A Civil penalties for importing, supplying or exporting goods that
do not comply with standards
Civil penalty relating to importing goods into Australia
(1) A person contravenes this subsection if:
(a) the person imports therapeutic goods into Australia; and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than by reason of a matter relating to labelling
or packaging).
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(1A) Subsection (1) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person imports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
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Civil penalty relating to supplying goods for use in Australia
(2) A person contravenes this subsection if:
(a) the person supplies therapeutic goods for use in Australia;
and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception
(2A) Subsection (2) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person supplies the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Civil penalty relating to exporting goods from Australia
(3) A person contravenes this subsection if:
(a) the person exports therapeutic goods from Australia; and
(b) the person does not have the consent in writing of the
Secretary; and
(c) the goods do not conform with a standard applicable to the
goods (other than a standard relating to the labelling of the
goods for supply in Australia).
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Exception
(3A) Subsection (3) does not apply if:
(a) the therapeutic goods are a biological; and
(b) the person exports the biological after the circumstances
prescribed by the regulations for the purposes of this
paragraph have occurred.
Decisions on whether to give consent
(4) The Secretary must, as soon as practicable after making a decision
to give a consent, cause particulars of the decision to be published
in the Gazette or on the Department’s website.
(5) The Secretary must, within 28 days after making a decision to
refuse to give a consent, notify the applicant in writing of the
decision and of the reasons for the decision.
14B Application of Customs Act 1901
Where:
(a) the importation or exportation of goods is an offence under
subsection 14(1), (4), (4A), (10), (13) or (13AA) or a
contravention of subsection 14A(1) or (3); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
15 Criminal offences relating to breaching a condition of a consent
(1) The consent of the Secretary under section 14 or 14A may be
given:
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(a) unconditionally or subject to conditions; or
(b) in respect of particular goods or classes of goods.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: 2,000 penalty units.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 500 penalty units.
(6) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent.
Penalty: 100 penalty units.
(7) An offence against subsection (6) is an offence of strict liability.
15AA Civil penalty relating to breaching a condition of a consent
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a condition of a consent
imposed under section 15.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
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(b) for a body corporate—30,000 penalty units.
15AB Conditions relating to exceptional release of biologicals
(1) Regulations made for the purposes of paragraphs 14(9A)(b) and
14A(2A)(b) may also prescribe conditions that apply in relation to
the supply of a biological that occurs after the circumstances
prescribed for the purposes of those paragraphs have occurred.
(2) The conditions prescribed by those regulations must apply only to
the person supplying the biological.
(3) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of any of the
conditions referred to in subsection (1).
Penalty for contravention of this subsection:60 penalty units.
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Part 3-2—Registration and listing of therapeutic
goods
Division 1—Preliminary
15A Application of this Part to medical devices
The general rule
(1) This Part does not apply to a medical device unless this section
provides otherwise.
Previously registered or listed devices
(2) If a medical device is registered goods or listed goods before the
commencement of this section, this Part continues to apply to the
device unless the registration or listing is cancelled.
Note: A registration or listing can be cancelled under section 30, or can be
taken to be cancelled under section 9B.
Pending applications
(3) This Part continues to apply to a medical device if:
(a) before the commencement of this section, an application was
made under Part 3 for registration or listing of therapeutic
goods that include that medical device; and
(b) immediately before that commencement, the application was
not yet finally determined; and
(c) the application has not been, and is not, withdrawn either
before or after that commencement.
However, this Part ceases to apply to the device if, having been
registered goods or listed goods, the registration or listing is
cancelled.
(4) For the purposes of paragraph (3)(b), an application is finally
determined when the application, and any applications for review
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or appeals arising out of it, have been finally determined or
otherwise disposed of.
Applications made within 2 years relating to certain medical
devices
(5) This Part applies to a medical device if:
(a) regulations made for the purposes of this section specified
either:
(i) the medical device classification applying to the kind of
medical device that includes that device; or
(ii) medical devices of that kind; and
(b) during the period of 2 years after the commencement of this
section, an application was made under Part 3-2 for
registration or listing of therapeutic goods that include that
medical device.
However, this Part ceases to apply to the device if, having been
registered goods or listed goods, the registration or listing is
cancelled.
Note: Medical devices that are registered or listed because of this subsection
are taken to be cancelled 2 years after Chapter 4 commences, or
before then if medical devices of that kind are included in the Register
under Chapter 4: see subsection 9B(1).
Medical devices that are exempt goods
(6) This Part applies to a medical device, during the period of 2 years
after the commencement of this section, if the device is exempt
goods.
Existing approvals under section 19
(7) This Part continues to apply to a medical device if:
(a) an approval or authorisation in force under section 19 applies
to the device; and
(b) that approval or authorisation was in force immediately
before the commencement of this section.
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New approvals under section 19
(8) This Part applies to a medical device if:
(a) subsection (7) does not apply to the device; and
(b) during the period of 2 years after the commencement of this
section, an approval is granted or an authorisation is given
under section 19 that applies to the device.
However, this subsection does not apply after the end of that
period.
15B Application of this Part to a biological
(1) Subject to this section, this Part does not apply to a biological on
and after the commencement of this section.
Biologicals currently included in the Register
(2) If, immediately before the commencement of this section,
therapeutic goods that are a biological were registered goods or
listed goods, this Part continues to apply to the biological on and
after that commencement until the time the biological is included
in the Register under Part 3-2A.
Note: Section 32DN deals with including the biological under Part 3-2A.
Pending applications
(3) If:
(a) before the commencement of this section, an application was
made under this Part for the registration or listing of
therapeutic goods that are a biological; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application had not been withdrawn before that
commencement;
this Part continues to apply to the biological on and after that
commencement until the earliest of the following:
(d) the time the biological is included in the Register under
Part 3-2A;
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(e) if the application is unsuccessful when it is finally
determined—the time the application is finally determined;
(f) the time the application is withdrawn;
(g) the time the application lapses.
Note: Section 32DN deals with including the biological under Part 3-2A.
(4) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Transitional
(5) This Part applies to a biological on and after the commencement of
this section in relation to things done, or omitted to be done, in
relation to the biological before the commencement of this section.
(6) If this Part continues to apply to a biological during a period
described in subsection (2) or (3), then this Part also applies to the
biological after the end of that period in relation to things done, or
omitted to be done, in relation to the biological during that period.
16 Therapeutic goods and gazetted groups
(1) For the purposes of this Part, therapeutic goods (other than
medicine of the kind to which subsection (1A) applies) are to be
taken to be separate and distinct from other therapeutic goods if
they have:
(a) a different formulation, composition or design specification;
or
(b) a different strength or size (disregarding pack size); or
(c) a different dosage form or model; or
(d) a different name; or
(e) different indications; or
(f) different directions for use; or
(g) a different type of container (disregarding container size).
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(1A) Medicines that are listable goods (other than export only
medicines) are taken to be separate and distinct from other
therapeutic goods if the medicines have:
(a) different active ingredients; or
(b) different quantities of active ingredients; or
(c) a different dosage form; or
(d) such other different characteristics as the regulations
prescribe;
from the therapeutic goods.
(2) The Secretary may, by order published in the Gazette, determine
that a group of therapeutic goods (not being medical devices or
therapeutic devices) identified in the order is a gazetted therapeutic
goods group because the goods within the group have common
characteristics.
(3) The Secretary may, by order published in the Gazette, determine
that a group of therapeutic goods (being therapeutic devices)
identified in the order is a gazetted therapeutic devices group
because the goods within the group:
(a) have common characteristics; and
(b) have been produced by the same manufacturer.
(3A) The Secretary may, by order published in the Gazette, determine
that a group of kits identified in the order is a gazetted kits group.
(4) An order under subsection (2), (3) or (3A) may make provision for
or in relation to a matter by applying, adopting or incorporating,
with or without modification, a document as in force from time to
time, if the document is:
(a) published by the Department (whether in electronic form or
otherwise); and
(b) available for sale to the public; and
(c) available for inspection (whether by using a visual display
unit or otherwise) by the public at offices of the Department
specified by the Secretary.
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18 Exempt goods
(1) The regulations may, subject to such conditions (if any) as are
specified in the regulations, exempt:
(a) all therapeutic goods, except those included in a class of
goods prescribed for the purposes of this paragraph; or
(b) specified therapeutic goods; or
(c) a specified class of therapeutic goods;
from the operation of this Part (except section 31A and
sections 31C to 31F).
(2) An exemption in terms of paragraph (1)(a) has effect only in
relation to such classes of persons as are prescribed for the
purposes of this subsection.
(3) Where the regulations revoke an exemption, the revocation takes
effect on the day, not being earlier than 28 days after the day on
which the regulations are made, specified in the regulations.
18A Exemption because of emergency
Minister’s power
(1) The Minister may exempt from the operation of Division 2 of this
Part:
(a) specified therapeutic goods; or
(b) therapeutic goods in a specified class.
The exemption must be made in writing.
(2) The Minister may exempt goods under subsection (1) only if the
Minister is satisfied that, in the national interest:
(a) the exemption should be made so that the goods may be
stockpiled as quickly as possible in order to create a
preparedness to deal with a potential threat to public health
that may be caused by a possible future emergency; or
(b) the exemption should be made so that the goods can be made
available urgently in Australia in order to deal with an actual
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threat to public health caused by an emergency that has
occurred.
When the exemption has effect
(3) The exemption takes effect:
(a) on the day on which the exemption is made; or
(b) on a later day that is specified in the exemption.
(4) The exemption ceases to have effect:
(a) at the end of the period specified by the Minister in the
exemption as the period for which the exemption is to have
effect; or
(b) when the exemption is revoked;
whichever first occurs.
(5) The exemption ceases to have effect in relation to particular
therapeutic goods:
(a) when those goods become registered or listed goods; or
(b) when the Minister varies the exemption by removing those
goods from the exemption;
whichever first occurs.
(6) If the Minister revokes the exemption as mentioned in
paragraph (4)(b), or varies the exemption as mentioned in
paragraph (5)(b), the revocation or variation takes effect:
(a) if the Minister states in the revocation or variation that the
revocation or variation is necessary to prevent imminent risk
of death, serious illness or serious injury—on the day on
which the revocation or variation is made; or
(b) in any other case—on the day specified by the Minister in the
revocation or variation.
The day specified under paragraph (b) of this subsection must not
be earlier than 28 days after the day on which the revocation or
variation is made.
Note: The revocation or variation must be made in writing, see
subsection 33(3) of the Acts Interpretation Act 1901.
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Conditions for the exemption
(7) The exemption is subject to conditions specified in the exemption
about any of the following:
(a) the period for which the exemption is to have effect;
(b) the quantity of goods that are exempt;
(c) the source of those goods;
(d) the persons or class of persons who may import,
manufacture, supply or export those goods;
(e) the supply of those goods (including the persons or class of
persons to whom goods may be supplied for use and the
circumstances under which a stockpile of goods may be
supplied for use);
(f) the storage and security of those goods;
(g) the keeping and disclosure of, and access to, records about
those goods;
(h) the disposal of those goods;
(i) the manner in which any of those goods are to be dealt with
if a condition of the exemption is breached;
(j) any other matters that the Minister thinks appropriate.
Whether or not goods are exempt under this section is not affected
by whether or not there is a breach of a condition of an exemption
under this section in relation to those goods.
Note 1: A person may commit an offence by breaching a condition of an
exemption under this section, see subsections 20(2A) and (2C),
22(7AB) and (7AD), and 30H(1) and (3).
Note 2: A person may also contravene a civil penalty provision, see
section 22AA.
(8) The Minister may revoke or vary the conditions (including by
imposing new conditions) after the exemption is made. The
revocation or variation must be made in writing.
(9) A revocation or variation under subsection (8) takes effect:
(a) if the Minister states in the revocation or variation that the
revocation or variation is necessary to prevent imminent risk
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of death, serious illness or serious injury—on the day on
which the revocation or variation is made; or
(b) in any other case—on the day specified by the Minister in the
revocation or variation.
The day specified under paragraph (b) must not be earlier than 28
days after the day on which the revocation or variation is made.
Exemption not a legislative instrument
(9A) An exemption under subsection (1) is not a legislative instrument.
Informing persons of exemption etc.
(9B) If the Minister makes an exemption under subsection (1), the
Minister must take reasonable steps to give a copy of the following
to each person covered by paragraph (7)(d):
(a) the exemption;
(b) any revocation or variation of the exemption under this
section.
Notification
(10) The Secretary must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b); and
(b) a revocation or variation under this section of an exemption
covered by paragraph (2)(b);
to be published in the Gazette within 5 working days after the day
on which the Minister makes the exemption, revocation or
variation. However, an exemption, or a revocation or variation, is
not invalid merely because of a failure to comply with this
subsection.
Tabling
(11) The Minister must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b); and
(b) a revocation or variation under this section of an exemption
covered by paragraph (2)(b);
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to be tabled before each House of the Parliament within 5 sitting
days of that House after the day on which the Minister makes the
exemption, revocation or variation. However, an exemption, or a
revocation or variation, is not invalid merely because of a failure to
comply with this subsection.
Note: There are other requirements in other parts of this Act about goods
exempt under this section:
(a) sections 20, 22 and 22AA (breach of a condition of the exemption);
(b) sections 30F and 30FA (goods not conforming to standards etc.);
(c) section 30G (disposal of unused goods);
(d) section 30H (record keeping);
(e) section 31AA (providing information to the Secretary);
(f) sections 35, 35A, 39 and 41 (manufacturing goods that are exempt under this section);
(g) section 46A (search of premises).
19 Exemptions for certain uses
(1) The Secretary may, by notice in writing, grant an approval to a
person for the importation into, or the exportation from, Australia
or the supply in Australia of specified therapeutic goods that are
not registered goods, listed goods or exempt goods:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
and such an approval may be given subject to such conditions as
are specified in the notice of approval.
(1AA) An approval for use of the kind referred to in paragraph (1)(a) must
not be granted to a person unless the person is a health practitioner.
(1A) An approval mentioned in paragraph (1)(a) or (b) is subject to the
conditions (if any) specified in the regulations for the purposes of
that paragraph. Those conditions (if any) are in addition to any
conditions imposed on the approval under subsection (1).
(2) An application for an approval must be made to the Secretary and
must:
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(a) in the case of an application for use of the kind referred to in
paragraph (1)(a)—be in a form (if any) approved, in writing,
by the Secretary and be accompanied by such information
relating to the goods the subject of the application as is
required by the Secretary; and
(b) in the case of an application for use of the kind referred to in
paragraph (1)(b):
(i) be made in writing; and
(ii) be accompanied by such information relating to the
goods the subject of the application as is required by the
Secretary; and
(iii) be accompanied by the prescribed evaluation fee.
(3) Without limiting the conditions to which an approval under
subsection (1) may be made subject, those conditions may include
a condition relating to the charges that may be made for the
therapeutic goods to which the approval relates.
(4) Where an application for an approval is made, the Secretary must,
after having considered the application and, in the case of an
application for the use of therapeutic goods for experimental
purposes in humans, after having evaluated the information
submitted with the application, notify the applicant of the decision
on the application within 28 days of making the decision and, in
the case of a decision not to grant the approval, of the reasons for
the decision.
(4A) The use by a person for experimental purposes in humans of
specified therapeutic goods that are the subject of an approval
granted to someone else under paragraph (1)(b) is subject to the
conditions (if any) specified in the regulations relating to one or
more of the following:
(a) the preconditions on the use of the goods for those purposes;
(b) the principles to be followed in the use of the goods for those
purposes;
(c) the monitoring of the use, and the results of the use, of the
goods for those purposes;
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(d) the circumstances in which the person must cease the use of
the goods for those purposes.
(5) The Secretary may, in writing, authorise a specified medical
practitioner to supply:
(a) specified therapeutic goods for use in the treatment of
humans; or
(b) a specified class of such goods;
to the class or classes of recipients specified in the authority.
(5AA) An application for an authority under subsection (5) must be in a
form (if any) approved, in writing, by the Secretary.
(5A) An authority may be given subject to the conditions (if any)
specified in the authority.
(5B) The Secretary may impose conditions (or further conditions) on an
authority given to a person under subsection (5) by giving to the
person written notice of the conditions (or further conditions).
(6) An authority under subsection (5) may only be given:
(a) to a medical practitioner included in a class of medical
practitioners prescribed by the regulations for the purposes of
this paragraph; and
(aa) to a medical practitioner who has the approval of an ethics
committee to supply the specified therapeutic goods or the
specified class of such goods; and
(b) in relation to a class or classes of recipients prescribed by the
regulations for the purposes of this paragraph.
Paragraph (aa) does not apply in the exceptional circumstances (if
any) prescribed by the regulations for the purposes of this
subsection.
(7) The regulations may prescribe the circumstances in which
therapeutic goods may be supplied under an authority under
subsection (5).
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(7A) The Minister may, by legislative instrument, make rules
authorising any health practitioner who is included in a specified
class of health practitioners to supply:
(a) specified therapeutic goods for use in the treatment of
humans; or
(b) a specified class of such goods;
to the class or classes of recipients specified in those rules, so long
as:
(c) the goods are supplied in the circumstances specified in those
rules; and
(d) the conditions (if any) specified in those rules are satisfied.
(7B) In making rules under subsection (7A), the Minister must comply
with:
(a) such requirements (if any) as are prescribed by the
regulations; and
(b) such restrictions (if any) as are prescribed by the regulations;
and
(c) such limitations (if any) as are prescribed by the regulations.
(7C) If:
(a) a person is authorised, by subsection (7A) rules, to supply
therapeutic goods; and
(b) the person supplies those goods in accordance with those
rules;
the person must:
(c) notify the supply to the Secretary; and
(d) do so within 28 days after the supply.
(7D) A notification under subsection (7C) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain such information as is prescribed by the regulations.
(7E) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
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(b) by way of a specified kind of electronic transmission.
(7F) A person commits an offence if:
(a) the person is subject to a requirement under subsection (7C);
and
(b) the person omits to do an act; and
(c) the omission breaches the requirement.
Penalty: 10 penalty units.
(7G) An offence against subsection (7F) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(7GA) Subsection (7F) does not apply in relation to a person and a
requirement to notify a supply of therapeutic goods if a health
practitioner, on behalf of the person, does the following:
(a) notifies the supply to the Secretary within 28 days after the
supply;
(b) makes the notification in accordance with the requirements
referred to in subsection (7D).
Note: A defendant bears an evidential burden in relation to the matter in
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
(7H) In recommending to the Governor-General that regulations should
be made for the purposes of paragraph (7D)(b), the Minister must
have regard to the principle that information should only be
prescribed for the purposes of that paragraph if the information is
reasonably required for the responsible scrutiny by the Secretary of
the operation of the scheme embodied in subsection (7A).
(8) The regulations may prescribe the circumstances in which an
approval under paragraph (1)(a) must not be given, including but
not limited to, circumstances relating to the following:
(a) therapeutic goods included in a specified class;
(b) therapeutic goods when used in the treatment of a specified
class of persons;
(c) therapeutic goods when used for a particular indication.
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Section 19A
(9) In this section, medical practitioner means a person who is
registered, in a State or internal Territory, as a medical practitioner.
19A Exemptions where unavailability etc. of therapeutic goods
(1) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
are unavailable or are in short supply; and
(b) either:
(i) the goods that are the subject of the application are
registered or approved for general marketing in at least
one foreign country specified by the Secretary in a
determination under subsection (3); or
(ii) an application under section 23 has been made for
registration of the goods and the application has passed
preliminary assessment; and
(c) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(d) the approval is necessary in the interests of public health.
(1A) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
are unavailable or are in short supply; and
(b) either:
(i) the goods that are the subject of the application are not
registered or approved for general marketing in any of
the foreign countries specified by the Secretary in a
determination under subsection (3); or
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(ii) the goods that are the subject of the application are
registered or approved for general marketing in at least
one foreign country specified by the Secretary in a
determination under subsection (3), but are not readily
available for importation into, and supply in, Australia;
and
(c) the goods are registered or approved for general marketing in
a foreign country; and
(d) the manufacturing and quality control procedures used in the
manufacture of the goods are acceptable; and
(e) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(f) the approval is necessary in the interests of public health.
(2) The Secretary may, by notice in writing, grant an approval to a
person for the importation into Australia, or the supply in
Australia, of specified therapeutic goods if the Secretary is satisfied
that:
(a) registered goods that could act as a substitute for the goods
do not exist; and
(b) an application under section 23 has been made for
registration of the goods; and
(ba) the application has passed preliminary assessment; and
(c) the goods are of a kind:
(i) included in Schedule 10 of the Therapeutic Goods
Regulations; or
(ii) specified by the Secretary in a determination under
subsection (4); and
(d) the approval is necessary in the interests of public health.
(3) The Secretary may, for the purposes of subparagraph (1)(b)(i),
make written determinations specifying the foreign countries in
which registration or approval for general marketing of the goods
is a prerequisite for approval by the Secretary under subsection (1).
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(4) The Secretary may make written determinations specifying the
kinds of goods that can be the subject of an approval under this
section.
(5) Determinations under subsections (3) and (4) are legislative
instruments.
(6) The Secretary may grant the approval subject to any conditions that
are specified in the notice of approval.
(7) The Secretary may grant the approval for such period as is
specified in the notice of approval.
(8) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made under subsection 25(3) in relation
to the goods.
(9) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d),
paragraph (1A)(a), (b), (c), (d), (e) or (f), or paragraph (2)(a),
(b), (ba), (c) or (d), as the case requires, no longer applies in
relation to the goods, or that a condition of the approval has
been contravened; and
(b) the Secretary has given to the person to whom the approval
was granted a notice stating that the Secretary is so satisfied.
(10) The lapsing of the approval on the expiry of the period specified in
the notice of approval does not prevent another approval being
granted under this section in relation to the goods before the
lapsing of the first-mentioned approval. The other approval may be
expressed to take effect on the expiry of that period.
(11) An approval under subsection (1), (1A) or (2) is not a legislative
instrument.
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19B Criminal offences relating to registration or listing etc. of
imported, exported, manufactured and supplied
therapeutic goods
Offences relating to importing, exporting, manufacturing or
supplying goods for use in humans
(1) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A; and
(c) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: A person may commit an offence against subsection 20(2A) or (2C),
or may contravene section 22AA (a civil penalty provision), by
importing into Australia therapeutic goods that are exempt under
section 18A.
Note 3: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person:
(i) imports into Australia therapeutic goods for use in
humans; or
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(ii) exports from Australia therapeutic goods for use in
humans; or
(iii) manufactures in Australia therapeutic goods for use in
humans; or
(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defence if person was not the sponsor of the goods
(5) It is a defence to a prosecution under subsection (1), (4) or (4A) if
the defendant proves that the defendant was not the sponsor of the
goods at the time of the importation, exportation, manufacture or
supply, as the case may be.
Note: The defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
Exception
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the goods; or
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Section 19C
(ii) a matter relating to the labelling or packaging of the
goods; or
(iii) the improper use of the goods; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the goods; or
(ii) a matter relating to the labelling or packaging of the
goods; or
(iii) the improper use of the goods.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
Application of Customs Act 1901
(7) Where:
(a) the importation or exportation of goods is an offence under
subsection (1), (4) or (4A); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
19C Notice required to adduce evidence in support of exception
under subsection 19B(6)
(1) If:
(a) a defendant is committed for trial for an offence against
subsection 19B(1); or
(b) an offence against subsection 19B(1) is to be heard and
determined by a court of summary jurisdiction;
the committing magistrate or the court must:
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(c) inform the defendant of the requirements of this section; and
(d) cause a copy of this section to be given to the defendant.
(2) A defendant must not, without leave of the court, adduce evidence
in support of the exception under subsection 19B(6) unless:
(a) if paragraph (1)(a) applies—more than 21 days before the
trial begins; or
(b) if paragraph (1)(b) applies—more than 21 days before the
hearing of the offence begins;
he or she gives notice of particulars of the exception.
(3) A defendant must not, without leave of the court, call any other
person to give evidence in support of the exception unless:
(a) the notice under subsection (2) includes the name and
address of the person or, if the name and address is not
known to the defendant at the time he or she gives the notice,
any information in his or her possession that might be of
material assistance in finding the person; and
(b) if the name or the address is not included in the notice—the
court is satisfied that the defendant before giving the notice
took, and after giving the notice continued to take, all
reasonable steps to ascertain the name or address; and
(c) if the name or address is not included in the notice, but the
defendant subsequently ascertains the name or address or
receives information that might be of material assistance in
finding the person—the defendant immediately gives notice
of the name, address or other information, as the case may
be; and
(d) if the defendant is told by or on behalf of the prosecutor that
the person has not been found by the name, or at the address,
given by the defendant:
(i) the defendant immediately gives notice of any
information in the defendant’s possession that might be
of material assistance in finding the person; or
(ii) if the defendant later receives any such information—
the defendant immediately gives notice of the
information.
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Section 19D
(4) A notice purporting to be given under this section on behalf of the
defendant by his or her legal practitioner is, unless the contrary is
proved, taken as having been given with the authority of the
defendant.
(5) Any evidence tendered to disprove that the exception applies may,
subject to direction by the court, be given before or after evidence
is given in support of the exception.
(6) A notice of particulars of the exception must be given, in writing,
to the Director of Public Prosecutions. A notice is taken as having
been given if it is:
(a) delivered to or left at the Office of the Director of Public
Prosecutions; or
(b) sent by certified mail addressed to the Director of Public
Prosecutions at the Office of the Director of Public
Prosecutions.
(7) In this section:
Director of Public Prosecutions means a person holding office as,
or acting as, the Director of Public Prosecutions under the Director
of Public Prosecutions Act 1983.
19D Civil penalties relating to registration or listing etc. of imported,
exported, manufactured and supplied therapeutic goods
Civil penalty relating to importing, exporting, manufacturing or
supplying goods for use in humans
(1) A person contravenes this subsection if:
(a) the person does any of the following:
(i) imports into Australia therapeutic goods for use in
humans;
(ii) exports from Australia therapeutic goods for use in
humans;
(iii) manufactures in Australia therapeutic goods for use in
humans;
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(iv) supplies in Australia therapeutic goods for use in
humans; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods in relation
to the person;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19;
(v) the goods are the subject of an approval under
section 19A.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Note: A person may commit an offence against subsection 20(2A) or (2C),
or may contravene section 22AA (a civil penalty provision), by
importing into Australia therapeutic goods that are exempt under
section 18A.
Exception if person was not the sponsor of the goods
(2) Subsection (1) does not apply if the person proves that he or she
was not the sponsor of the goods at the time of the importation,
exportation, manufacture or supply, as the case may be.
Civil penalty relating to the importing of registered or listed goods
(3) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person (other than listed goods that are therapeutic devices);
and
(b) the person imports the goods into Australia; and
(c) the registration number or listing number of the goods is not
set out on the label of the goods in the prescribed manner
before the goods are supplied in Australia.
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Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Civil penalty relating to the supply of registered or listed goods
(4) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person (other than listed goods that are therapeutic devices);
and
(b) the person supplies the goods in Australia; and
(c) the registration number or listing number of the goods is not
set out on the label of the goods in the prescribed manner.
Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Application of Customs Act 1901
(5) Where:
(a) the importation or exportation of goods contravenes
subsection (1); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the goods included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
20 Criminal offences relating to notifying the Secretary and to
importing goods exempt under section 18A
(1B) A person commits an offence if:
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(a) the person is the sponsor of therapeutic goods for use in
humans; and
(b) the person:
(i) imports the goods into Australia; or
(ii) exports the goods from Australia; or
(iii) manufactures the goods in Australia; or
(iv) supplies the goods in Australia; and
(c) the person has not, at the time of the importation, export,
manufacture or supply, properly notified to the Secretary
either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(1BA) A person commits an offence if:
(a) the person is the sponsor of therapeutic goods for use in
humans; and
(b) the person:
(i) imports the goods into Australia; or
(ii) exports the goods from Australia; or
(iii) manufactures the goods in Australia; or
(iv) supplies the goods in Australia; and
(c) the person has not, at the time of the importation, export,
manufacture or supply, properly notified to the Secretary
either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Penalty: 100 penalty units.
(1BB) An offence against subsection (1BA) is an offence of strict
liability.
(1C) For the purposes of paragraphs (1B)(c) and (1BA)(c):
(a) a manufacturer is properly notified to the Secretary if:
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(i) the manufacturer was nominated, as a manufacturer of
the goods, in an application for the registration or listing
of the goods; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the goods; and
(b) premises are properly notified to the Secretary if:
(i) the premises were nominated, as premises used in the
manufacture of the goods, in an application for the
registration or listing of the goods; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the goods.
(2A) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are exempt under section 18A; and
(c) the importation breaches a condition of the exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(2B) Strict liability applies to paragraph (2A)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(2C) A person commits an offence if:
(a) the person imports therapeutic goods into Australia; and
(b) the goods are exempt under section 18A; and
(c) the importation breaches a condition of the exemption.
Penalty: 60 penalty units.
(2D) An offence under subsection (2C) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
20A Civil penalty relating to the importation, exportation,
manufacture or supply of sponsored goods without
proper notification
(1) A person contravenes this section if:
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(a) the person does any of the following:
(i) imports therapeutic goods into Australia;
(ii) exports therapeutic goods from Australia;
(iii) manufactures therapeutic goods in Australia;
(iv) supplies therapeutic goods in Australia; and
(b) the person is the sponsor of the goods for use in humans; and
(c) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the goods;
(ii) premises used in the manufacture of the goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Meaning of properly notified
(2) For the purposes of paragraph (1)(c):
(a) a manufacturer is properly notified to the Secretary if:
(i) the manufacturer was nominated, as a manufacturer of
the goods, in an application for the registration or listing
of the goods; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the goods; and
(b) premises are properly notified to the Secretary if:
(i) the premises were nominated, as premises used in the
manufacture of the goods, in an application for the
registration or listing of the goods; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the goods.
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21 Offence relating to wholesale supply
A person must not supply in Australia therapeutic goods for use in
humans (other than listable devices), being goods of which the
person is not a sponsor, to another person who is not the ultimate
consumer of the goods unless:
(a) the goods are registered goods or listed goods; or
(b) the goods are exempt goods; or
(ba) the goods are exempt under section 18A; or
(c) the goods are the subject of an approval or authority under
section 19; or
(d) the goods are the subject of an approval under section 19A.
Penalty: 120 penalty units.
21A General criminal offences relating to this Part
Offences for making a false or misleading statement
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the medicine has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with a certification
of any matter under subsection 26A(2) or 26AB(2); and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to breaching a condition of registration or listing
of therapeutic goods
(5) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (8) instead:
see section 53A.
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Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(8) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(8A) A person commits an offence if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the registration or
listing of the goods.
Penalty: 100 penalty units.
(8B) An offence against subsection (8A) is an offence of strict liability.
Offences relating to the supply of therapeutic goods in breach of
authority etc.
(9) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7); and
(d) either:
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(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(9A) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: 500 penalty units.
(10) A person commits an offence if:
(a) the Secretary has authorised, under subsection 19(5), the
person to supply therapeutic goods; and
(b) the person supplies those goods; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
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(iii) the supply is not in accordance with regulations made
for the purpose of subsection 19(7).
Penalty: 100 penalty units.
(11) An offence against subsection (10) is an offence of strict liability.
(11A) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules; and
(e) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with those rules; or
(ii) the supply is not in the circumstances specified in those
rules; or
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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(11C) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 500 penalty units.
(11D) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 19(7A) rules; and
(c) the person supplies:
(i) therapeutic goods specified in those rules; or
(ii) therapeutic goods included in a class of therapeutic
goods specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 100 penalty units.
(11E) An offence against subsection (11D) is an offence of strict liability.
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Offences relating to using therapeutic goods without approval etc.
(12) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A); and
(e) either:
(i) if the person used the goods in the treatment of another
person—the use of the goods has resulted in, will result
in, or is likely to result in, harm or injury to that person;
or
(ii) if the person used the goods solely for experimental
purposes in humans—the use of the goods has resulted
in, will result in, or is likely to result in, harm or injury
to any of those persons.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(12A) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
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(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A).
Penalty: 500 penalty units.
(13) A person commits an offence if:
(a) the person uses therapeutic goods; and
(b) the goods are used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) the goods are not:
(i) exempt goods; or
(ii) listed goods; or
(iii) registered goods; or
(iv) goods exempt under section 18A; or
(v) goods that are the subject of an approval under
section 19A; and
(d) the goods are not used in accordance with:
(i) an approval or authority under section 19; or
(ii) a condition applicable under regulations made for the
purposes of subsection 19(4A).
Penalty: 100 penalty units.
(14) An offence against subsection (13) is an offence of strict liability.
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21B General civil penalties relating to this Part
Civil penalty for making a false or misleading statement
(1) A person contravenes this subsection if the person, in or in
connection with a certification of any matter under
subsection 26A(2) or 26AB(2), makes a statement that is false or
misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty relating to breaching a condition of registration or
listing of therapeutic goods
(2) A person contravenes this subsection if:
(a) therapeutic goods are registered or listed in relation to the
person; and
(b) the person does an act or omits to do an act that breaches a
condition of the registration or listing of the goods.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty for falsely representing therapeutic goods
(3) A person contravenes this subsection if:
(a) the person represents therapeutic goods that are not included
in the Register as being so included; or
(b) the person represents therapeutic goods that are not exempt
goods as being exempt goods; or
(c) the person represents therapeutic goods that are not goods
exempt under section 18A as being goods exempt under that
section; or
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(d) the person represents therapeutic goods that are included in
one part of the Register as being included in another part of
the Register; or
(e) the person represents therapeutic goods that are not the
subject of an approval or authority under section 19 as being
the subject of such an approval or authority; or
(f) the person represents therapeutic goods that are not the
subject of an approval under section 19A as being the subject
of such an approval.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Civil penalty for advertising therapeutic goods for an indication
(4) A person contravenes this subsection if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
22 General offences relating to this Part
(1) A person must not set out or cause to be set out, on a container or
package that contains therapeutic goods or on a label of goods of
that kind, a number that purports to be the registration number or
listing number of the goods in relation to a particular person if the
number is not that number.
Penalty: 60 penalty units.
(2) A person commits an offence if:
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(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion; and
(d) either:
(i) the use of the goods for the advertised indication has
resulted in, will result in, or is likely to result in, harm
or injury to any person; or
(ii) the use of the goods for the advertised indication, if the
goods were so used, would result in, or would be likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(3) A person commits an offence if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person, by any means, advertises therapeutic goods for an
indication; and
(b) the therapeutic goods are included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: 100 penalty units.
(5A) An offence against subsection (5) is an offence of strict liability.
(6) A person commits an offence if:
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(a) the person claims, by any means, that the person or another
person can arrange the supply of therapeutic goods; and
(b) none of the following subparagraphs applies in relation to the
goods:
(i) the goods are registered goods or listed goods;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority
under section 19 that covers the supply of the goods by
the person or other person;
(v) the goods are the subject of an approval under
section 19A that covers the supply of the goods by the
person or other person.
Penalty: 60 penalty units.
(7) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of:
(i) a condition of an exemption applicable under
regulations made for the purposes of subsection 18(1);
or
(ii) a condition of an approval under section 19; or
(iii) a condition applicable under regulations made for the
purposes of subsection 19(4A); or
(iv) a condition of an approval under section 19A.
(7AA) An offence against subsection (7) is punishable on conviction by a
fine of not more than 60 penalty units.
(7AB) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the
exemption; and
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(d) the act or omission is likely to cause a serious risk to public
health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note 1: A person may commit an offence against subsection 20(2A) or (2C),
or contravene section 22AA (a civil penalty provision), by breaching a
condition of an exemption of therapeutic goods under section 18A that
relates to the importation of the goods.
Note 2: A person may commit an offence against subsection 30H(1) or (3) by
breaching a condition of an exemption of therapeutic goods under
section 18A that relates to records about the goods.
Note 3: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(7AC) Strict liability applies to paragraph (7AB)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(7AD) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(7AE) Strict liability applies to paragraph (7AD)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
22AA Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to
therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission breaches a condition of the exemption.
Maximum civil penalty:
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(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
22A Criminal offences for false statements in applications for
registration
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
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(b) the statement is made in or in connection with an application
for registration of therapeutic goods; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
22B Civil penalty for false statements in applications for registration
A person contravenes this section if the person in or in connection
with an application for registration of therapeutic goods, makes a
statement that is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Provisional determinations for medicine Division 1A
Section 22C
Division 1A—Provisional determinations for medicine
22C Applications for provisional determination
(1) A person may make an application to the Secretary for a
provisional determination relating to a medicine of a kind
prescribed by the regulations for the purposes of this subsection.
Note: If the Secretary makes the determination, the person applies under
section 23 for registration of the medicine and that application passes
preliminary assessment, then a different kind of evaluation of the
medicine will occur under section 25.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) be accompanied by the prescribed application fee; and
(c) contain the information that the form requires, and any
further information, statement or document the Secretary
requires, whether in the form or otherwise; and
(d) satisfy any other requirement prescribed by the regulations
for the purposes of this paragraph.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
22D Provisional determinations
(1) If a person makes an application, in accordance with
subsection 22C(2), for a provisional determination relating to a
medicine, the Secretary must decide to make, or to refuse to make,
the determination.
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Section 22E
Criteria
(2) The Secretary may make the determination if the Secretary is
satisfied that the criteria prescribed by the regulations for the
purposes of this subsection are met in relation to the medicine.
Content of determination
(3) The determination must specify:
(a) the person to whom the determination relates; and
(b) the medicine to which the determination relates; and
(c) the indication of the medicine to which the determination
relates; and
(d) each active ingredient of the medicine to which the
determination relates.
The determination may specify any other matters that the Secretary
considers appropriate.
Notice of decision
(4) As soon as practicable after making the decision, the Secretary
must:
(a) give the person written notice of the decision; and
(b) if the Secretary refuses to make the determination—set out
the reasons for the refusal in the notice.
22E Period during which provisional determination is in force
(1) A provisional determination under section 22D relating to a
medicine:
(a) comes into force on the day on which the Secretary gives the
person notice under subsection 22D(4); and
(b) subject to this section and section 22F, remains in force for
the initial period.
Note: For revocation of the determination, see section 22F.
(2) The initial period is 6 months or another period prescribed by the
regulations for the purposes of this subsection.
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Section 22E
Extensions
(3) The person may make an application to the Secretary to extend the
initial period.
(4) The application must:
(a) be in a form approved, in writing, by the Secretary; and
(b) be made at least 28 days before the determination would
otherwise cease to be in force; and
(c) be accompanied by the prescribed application fee.
(5) On receiving the application, the Secretary must decide to extend,
or to refuse to extend, the initial period.
(6) The Secretary may extend the initial period by 6 months, or
another period prescribed by the regulations for the purposes of
this subsection, if the Secretary:
(a) is still satisfied that the criteria prescribed by the regulations
for the purposes of subsection 22D(2) are met in relation to
the medicine; and
(b) is satisfied that, if the Secretary were to make the extension,
the person would make an application under section 23 for
provisional registration of the medicine before the end of the
extended period.
(7) As soon as practicable after making the decision, the Secretary
must:
(a) give the person written notice of the decision; and
(b) if the Secretary refuses to extend the initial period—set out
the reasons for the refusal in the notice.
(8) Only one extension may be given.
Effect of application under section 23
(9) If the person to whom the provisional determination relates makes
an application under section 23 for provisional registration of the
medicine before the end of the initial period (or that period as
extended), the determination remains in force until:
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Section 22F
(a) the person withdraws the application; or
(b) the application lapses in accordance with subsection 24(2); or
(c) the person gives the Secretary written notice under
subsection 24E(2) that the person wishes to treat the
application as having been refused; or
(d) the application is finally determined.
(10) For the purposes of paragraph (9)(d), an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
22F Revocation of provisional determination
Revocation on Secretary’s own initiative
(1) The Secretary may revoke a provisional determination under
section 22D relating to a person and a medicine if the Secretary is
satisfied that the criteria prescribed by the regulations for the
purposes of subsection 22D(2) are no longer met in relation to the
medicine.
Revocation on request
(2) The Secretary must revoke a provisional determination under
section 22D relating to a person and a medicine if the person
requests the Secretary, in writing, to do so.
Notice of revocation
(3) As soon as practicable after making a revocation under this section,
the Secretary must:
(a) give the person written notice of the revocation; and
(b) for a revocation under subsection (1)—set out the reasons for
the revocation in the notice.
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Section 22F
Day revocation takes effect
(4) A revocation under this section takes effect on the day on which
the Secretary gives the person notice of the revocation.
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Section 23
Division 2—Registration and listing
23 Applications generally
A person may make an application to the Secretary for registration
or listing of therapeutic goods.
23AA Applications for provisional registration of medicine
If:
(a) a person makes an application under section 23 for the
registration of a medicine; and
(b) a provisional determination under section 22D relating to the
person, the medicine and the indication to which the
application relates is in force when the application is made;
then, for the purposes of this Act, the application is taken to be an
application for provisional registration of the medicine.
23A Classes of therapeutic goods
The Secretary may, by notifiable instrument, specify different
classes of therapeutic goods for the purposes of section 23B.
23B Requirements relating to applications for registration of
therapeutic goods and listing of medicines under
section 26AE
(1) If an application is made under section 23 for:
(a) registration of therapeutic goods (including an application for
provisional registration of a medicine); or
(b) the listing of a medicine under section 26AE;
the Secretary must carry out an assessment of whether the
requirements set out in subsection (2) have been met in relation to
the application.
(2) The requirements are as follows:
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(a) the application must be made:
(i) in accordance with the form approved, in writing, by the
Secretary for that class of therapeutic goods; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that class of therapeutic goods;
(b) the prescribed application fee for that class of therapeutic
goods must be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (9) for that class
of therapeutic goods; and
(ii) in a form determined under subsection (10) for that
class of therapeutic goods;
(e) if the application is for the registration of restricted
medicine—the application must be accompanied by product
information, in relation to the medicine, that is in the form
approved under section 7D in relation to the medicine;
(f) if the Secretary so requires—the applicant must:
(i) deliver to the Department a reasonable number of
samples of the goods; and
(ii) do so in a manner approved, in writing, by the
Secretary.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has passed preliminary assessment, the Secretary
must give a written notice to the applicant stating that the
application has passed preliminary assessment.
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(5) Subsection (4) does not apply if the period within which the
Secretary must, under section 25, evaluate the goods to which the
application relates is prescribed by reference to the prescribed
period within which the Secretary is required to consider an
application under subsection 9D(3) to vary an entry in the Register.
(6) If the application has not passed preliminary assessment, the
Secretary must, by written notice given to the applicant, refuse the
application.
Approval of forms etc.
(7) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and different manners for making applications for
different classes of therapeutic goods that are specified under
section 23A.
(8) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(9) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to a class of therapeutic goods that is
specified under section 23A.
(10) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to a class of therapeutic goods that is
specified under section 23A.
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23C Requirements relating to applications for listing of therapeutic
goods under section 26 or 26A
(1) This section applies if an application is made under section 23 for
listing of therapeutic goods under section 26 or 26A.
(2) The application complies with this section if:
(a) the application is made in accordance with a form approved,
in writing, by the Secretary or in such other manner as is
approved, in writing, by the Secretary for the purposes of this
paragraph; and
(b) the application is delivered to an office of the Department
specified by the Secretary; and
(c) the prescribed application fee has been paid; and
(d) the applicant has delivered to the office to which the
application was made such information, in a form approved,
in writing, by the Secretary, as will allow the determination
of the application; and
(e) if the Secretary so requires—the applicant has delivered to
the office to which the application was made a reasonable
number of samples of the goods.
Note: To be listed, an application must comply with this section: see
sections 26, 26AA, 26A and 26AB.
(3) The Secretary may, by legislative instrument, determine forms of
information for the purposes of the application of paragraph (2)(d).
(4) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
24 Applications for registration
(1) This section applies if:
(a) an application is made for the registration of therapeutic
goods under section 23; and
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(b) the goods are goods that are required to be registered; and
(c) the application has passed preliminary assessment.
(1A) A fee specified in, or determined in accordance with, the
regulations is payable by the applicant in respect of the evaluation
of the goods for registration, and the Secretary must notify each
such applicant of the amount of the evaluation fee.
(2) An application for registration of therapeutic goods lapses if:
(a) any part of the evaluation fee payable in respect of those
goods remains unpaid at the end of the period of 2 months
after the day on which the amount became due and payable;
or
(b) the application contains information that is inaccurate or
misleading in a material particular; or
(c) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 31, is inaccurate or misleading in a material
particular; or
(d) the applicant fails to comply with a requirement under
section 31 to give information consisting of individual patient
data in relation to the goods.
(3) In this section, individual patient data, in relation to therapeutic
goods, means information, derived from clinical trials, relating to
individuals before, during and after the administration of the goods
to those individuals, including, but not limited to, demographic,
biochemical and haematological information.
24A When evaluation fee due for payment
Subject to section 24B, an evaluation fee under section 24 payable
by an applicant is due and payable on the day on which the
applicant is notified of the amount of the evaluation fee.
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24B Payment of evaluation fee by instalments
(1) The regulations may provide for the payment of an evaluation fee
under section 24 to be made by such instalments and at such times
as are ascertained in accordance with the regulations, and the
evaluation fee is due and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an evaluation fee under section 24
by instalments if any part of an instalment of:
(a) that or any other evaluation fee under section 24 payable by
the person; or
(b) any assessment fee under section 41LA payable by the
person;
was unpaid immediately after the time when it became due for
payment.
(3) Subsection (2) does not limit the generality of subsection (1).
24C Recovery of evaluation fee
An evaluation fee under section 24 may be recovered by the
Commonwealth as a debt due to the Commonwealth.
24D Refund of evaluation fee where evaluation not completed within
prescribed period
(1) This section applies to an application under section 23 in relation
to therapeutic goods for the evaluation of which a period is
prescribed under paragraph 63(2)(da).
(2) If:
(a) the applicant has paid the whole of the evaluation fee; and
(b) the evaluation is completed, but not within the period
referred to in subsection (1);
then 25% of the evaluation fee must be refunded to the applicant.
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(3) For the purposes of subsection (2), the evaluation is taken to be
completed when the applicant is notified of the Secretary’s
decision under subsection 25(3) in relation to the goods.
24E Deemed refusal of application
(1) This section applies in the case of an application under section 23
in relation to therapeutic goods for the evaluation of which a period
is prescribed under paragraph 63(2)(da).
(2) If, at the end of the period referred to in subsection (1), the
evaluation has not been completed, the applicant may give the
Secretary written notice that the applicant wishes to treat the
application as having been refused.
(3) A notice under subsection (2) may be given at any time before the
evaluation is completed.
(4) Where a notice has been given, this Act (except for subsection 60(5))
has effect as if:
(a) the Secretary had decided not to register the goods the
subject of the application; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (2).
25 Evaluation of therapeutic goods
(1) If:
(a) an application is made for the registration of therapeutic
goods in relation to a person under section 23; and
(b) the application has passed preliminary assessment;
the Secretary must evaluate the goods for registration having
regard to:
(c) unless the application is one referred to in paragraph (d)—
whether the quality, safety and efficacy of the goods for the
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purposes for which they are to be used have been
satisfactorily established; and
(d) for an application for provisional registration of a medicine:
(i) whether, based on preliminary clinical data, the safety
and efficacy of the medicine for the purposes for which
it is to be used have been satisfactorily established; and
(ii) whether the quality of the medicine for the purposes for
which it is to be used has been satisfactorily established;
and
(iii) whether, if the Secretary were to register the medicine,
the Secretary is satisfied with the applicant’s plan to
submit comprehensive clinical data on the safety and
efficacy of the medicine before the end of the 6 years
that would start on the day that registration would
commence; and
(da) if:
(i) the applicant is applying for the registration of restricted
medicine; or
(ii) the applicant is applying for the registration of medicine
(other than restricted medicine) and the applicant has
been given a notice in writing by the Secretary requiring
the applicant to give to the Secretary product
information, in relation to the medicine, that is in the
form approved under section 7D in relation to the
medicine;
the product information given by the applicant in relation to
the medicine; and
(e) whether the presentation of the goods is acceptable; and
(f) whether the goods conform to any standard applicable to the
goods; and
(fa) whether:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code; and
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or the regulations;
are complied with in relation to the goods; and
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(g) if a step in the manufacture of the goods has been carried out
outside Australia—whether the manufacturing and quality
control procedures used in the manufacture of the goods are
acceptable; and
(h) if the goods have been manufactured in Australia—whether
the goods have been manufactured in accordance with
Part 3-3; and
(j) whether the goods contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(ja) whether all of the manufacturers of the goods are nominated
as manufacturers of the goods in the application; and
(k) such other matters (if any) as the Secretary considers
relevant.
Note: The Secretary must not use protected information when evaluating
therapeutic goods for registration: see section 25A.
(2) In making a decision for the purposes of paragraph (1)(g), the
matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country that is a member of the European Community
or a member of EFTA—an EC/EFTA attestation of
conformity in relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country declared by the Minister under section 3B to be
covered by a non-EC/EFTA MRA—a non-EC/EFTA
attestation of conformity, for the non-EC/EFTA MRA,
in relation to the goods; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the goods is of an acceptable standard;
and
(b) whether the applicant has agreed to provide, where the
Secretary considers inspection of the manufacturing
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procedures used in the manufacture of the goods to be
necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) An evaluation under this section of goods in relation to which a
period has been prescribed under paragraph 63(2)(da) must be
completed within that period.
(2B) If therapeutic goods are exempt from the operation of Part 3-3 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to
the goods, as if paragraph (h) were omitted.
(2C) If a person is exempt from the operation of Part 3-3 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has
effect, in relation to the goods, as if the reference in paragraph (h)
to Part 3-3 were a reference to that Part to the extent that it applies
to that person in relation to the manufacture of the goods.
(2D) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been
exempt from the operation of Part 3-3;
subsection (1) has effect, in relation to the goods, as if
paragraph (g) were omitted.
(2E) A decision for the purposes of paragraph (1)(g) may also take into
account any information provided to the Secretary by a health
authority of a Convention country and relating to:
(a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted by a
particular manufacturer in relation to particular goods.
(2F) For the purposes of subsection (2E), a Convention country is a
country that is a party to the Mutual Recognition Convention.
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(2G) Information referred to in subsection (2E) and provided in
accordance with the Mutual Recognition Convention is to be
treated as equivalent to information obtained as a result of an
inspection under Part 3-3 of this Act.
(3) After an evaluation under this section of goods has been
completed, the Secretary must decide:
(a) to register the goods; or
(b) not to register the goods.
Note: See also sections 25AA (approved product information for medicine),
25AB (registration of therapeutic goods) and 25AC (notice of decision
not to register therapeutic goods).
25AAA Therapeutic goods (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make therapeutic goods (priority
applicant) determinations.
(2) A therapeutic goods (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 23 application that
may be made by the person for the registration of therapeutic
goods specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for therapeutic goods (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
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(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a therapeutic goods
(priority applicant) determination;
(b) the consequences of the revocation of a therapeutic goods
(priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) A period prescribed under paragraph 63(2)(da) for the evaluation
of therapeutic goods covered by a section 23 application for which
the applicant is a priority applicant may be shorter than the period
prescribed under that paragraph for the evaluation of therapeutic
goods covered by a section 23 application for which the applicant
is not a priority applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 23
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a therapeutic goods (priority applicant) determination is in force
under the regulations, the determination may be published on the
Department’s website.
(10) A therapeutic goods (priority applicant) determination made under
the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a therapeutic goods
(priority applicant) determination.
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Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
25AA Approved product information for medicine
(1) The Secretary must approve product information in relation to
therapeutic goods if:
(a) the Secretary decides, under subsection 25(3), to register the
goods; and
(b) the goods are:
(i) restricted medicine; or
(ii) medicine in respect of which the applicant has been
given a notice of the kind referred to in
subparagraph 25(1)(da)(ii).
Note: Subsection (4) deals with variation of the product information.
(1A) However, the Secretary must not approve product information in
relation to therapeutic goods under subsection (1) unless the
Secretary is satisfied that the product information reflects the basis
on which the Secretary decided under subsection 25(3) to register
the goods.
(1B) If:
(a) there is medicine included in the Register in relation to a
person and there is no product information approved under
this section in relation to the medicine; and
(b) the medicine becomes restricted medicine;
the Secretary may, by written notice given to the person, require
the person to:
(c) give the Secretary product information, in relation to the
medicine, that is in the form approved under section 7D in
relation to the medicine; and
(d) give the Secretary that product information within the period
specified in the notice (which must be at least 30 days after
the notice is given).
(1C) If the person complies with subsection (1B), the Secretary must
approve product information in relation to the medicine that
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reflects the basis on which the medicine is registered at the time of
the approval. The Secretary must, by written notice given to the
person, set out the product information so approved.
Note: Subsection (4) deals with variation of the product information.
Transitional
(2) If:
(a) at the start of the day the first instrument made under
subsection 3(2A) or (2B) takes effect, there is medicine
included in the Register in relation to a person; and
(b) before that day, the Secretary, in a notice given under
subsection 25(4) (as in force on that day) to the person in
relation to the registration of the medicine, specified the
product information that was approved by the Secretary in
relation to the medicine;
then that product information (including as varied before that day)
is, on and after that day, the product information that is approved
under this section in relation to the medicine.
Note: Subsection (4) deals with variation of the product information.
(3) If:
(a) before the day the first instrument made under
subsection 3(2A) or (2B) takes effect, a person made an
application to include medicine in the Register; and
(b) before that day and in relation to that application, the
Secretary, in a notice given under subsection 25(4) (as in
force on that day) to the person, specified the product
information that was approved by the Secretary in relation to
the medicine; and
(c) on or after that day and in relation to that application, the
Secretary includes the medicine in the Register in relation to
the person;
then that product information (including as varied before that
inclusion) is, on and after the day the registration of the medicine
commences, the product information that is approved under this
section in relation to the medicine.
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Note: Subsection (4) deals with variation of the product information.
Variations
(4) If:
(a) there is medicine included in the Register in relation to a
person and there is product information approved under this
section in relation to the medicine; and
(b) either:
(i) under section 9D, the Secretary varies the entry in the
Register in relation to the medicine; or
(ii) there is a change in the conditions to which the
inclusion of the medicine is subject; and
(c) as a result of that variation or change, the Secretary is
satisfied that a variation to that product information is
required;
the Secretary may, by notice in writing given to the person, make
any variations that the Secretary considers appropriate to the
product information that is approved in relation to the medicine.
(4A) Without limiting subsection (4), a variation to the product
information is not appropriate unless:
(a) if subparagraph (4)(b)(i) applies—the product information, as
varied, reflects the basis on which the Secretary decided
under section 9D to vary the entry in the Register in relation
to the medicine; or
(b) if subparagraph (4)(b)(ii) applies—the product information,
as varied, reflects the basis on which the Secretary decided
under section 28 to change the conditions to which the
inclusion of the medicine is subject.
(5) To avoid doubt, if product information that is approved in relation
to medicine is varied under this section, that product information,
as varied, becomes the product information that is approved under
this section in relation to the medicine.
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25AB Registration of therapeutic goods etc.
Therapeutic devices
(1) If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) to register the
goods; and
(c) the goods are therapeutic devices;
the Secretary must:
(d) notify the applicant in writing of the decision within 28 days
of making the decision; and
(e) include the goods in the Register; and
(f) give the applicant a certificate of registration.
Therapeutic goods that are not therapeutic devices
(2) If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) to register the
goods; and
(c) the goods are not therapeutic devices;
the Secretary must, in accordance with subsection (3), notify the
applicant in writing of the decision within 28 days of making the
decision.
(3) The notice must:
(a) set out the decision under subsection 25(3) to register the
goods; and
(b) if the goods are restricted medicine or medicine in respect of
which the applicant has been given a notice of the kind
referred to in subparagraph 25(1)(da)(ii)—set out the product
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information approved under subsection 25AA(1) for the
medicine; and
(c) inform the applicant that the goods will not be included in the
Register unless and until the applicant gives the Secretary:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application.
(4) If the applicant gives the Secretary the certificate referred to in
subparagraph (3)(c)(i) or the notice referred to in
subparagraph (3)(c)(ii), the Secretary must:
(a) include the goods in the Register; and
(b) give the applicant a certificate of registration.
(5) To avoid doubt, if the applicant gives the Secretary the certificate
referred to in subparagraph (3)(c)(i) or the notice referred to in
subparagraph (3)(c)(ii), the Secretary must include the goods in the
Register under paragraph (4)(a) without inquiring into the
correctness of the certificate or the notice.
Date registration commences
(6) The registration of therapeutic goods commences on the day
specified in the certificate of registration.
25AC Notice of decision not to register therapeutic goods
If:
(a) an application is made under section 23 for the registration of
therapeutic goods in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides under subsection 25(3) not to register
the goods;
the Secretary must notify the applicant in writing of the decision,
and the reasons for the decision, within 28 days of making the
decision.
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25A When the Secretary must not use protected information
(1) When evaluating therapeutic goods for registration, the Secretary
must not use information about other therapeutic goods that is
protected information.
(2) Information is protected information if:
(a) the information was given to the Secretary in relation to an
application to register therapeutic goods (the new goods):
(i) not being therapeutic devices; and
(ii) consisting of, or containing, an active component; and
(b) the information is about the active component and is not
available to the public; and
(c) when the application to register the new goods was lodged:
(i) no other therapeutic goods consisting of, or containing,
that active component were included in the Register;
and
(ii) no such therapeutic goods had been included in the
Register at any time before then; and
(d) the new goods became registered on or after the
commencement of this subsection; and
(e) 5 years have not passed since the day the new goods became
registered; and
(f) the person in relation to whom the new goods are registered
has not given the Secretary permission in writing for the
Secretary to use the information.
(3) For the purposes of subsection (2), an active component, in
relation to therapeutic goods, is a substance that is, or one of the
substances that together are, primarily responsible for the
biological or other effect identifying the goods as therapeutic
goods.
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25B Registration of therapeutic device to which EC/EFTA
attestation of conformity applies
(1) If:
(a) an application is made under section 23 for the registration of
a therapeutic device in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the applicant gives to the Secretary an EC/EFTA attestation
of conformity as to the matters that would require evaluation
under subsection 25(1) if that subsection applied in relation
to the device;
the Secretary must register the device unless the Secretary
considers that the device may compromise the health or safety of
users.
(2) The Secretary must notify the applicant in writing of his or her
decision on the application within 28 days of the making of the
decision. If the Secretary decides not to register the device, the
notice must contain the reasons for that decision.
(3) If the Secretary decides to register the device, the Secretary must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of registration.
(4) The registration of the device commences on the day specified for
the purpose in the certificate of registration.
26 Listing of therapeutic goods
(1) Where:
(a) an application is made for the listing of therapeutic goods in
relation to a person under section 23; and
(aaa) the application complies with section 23C; and
(aa) if goods are not therapeutic devices—the application is
accompanied by either:
(i) the certificate required under subsection 26B(1); or
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(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application;
and
(b) the person has complied with any requirements made by the
Secretary under section 31 in relation to the goods; and
(ba) the goods are not goods which may be listed under
section 26A or 26AE;
then, subject to this section and section 26AA, the Secretary is not
to refuse to list the goods in relation to the person except where the
Secretary is satisfied that:
(c) the goods are not eligible for listing; or
(d) the goods are not safe for the purposes for which they are to
be used; or
(e) the presentation of the goods is unacceptable; or
(f) the goods do not conform to a standard applicable to the
goods; or
(fa) either of the following has not been complied with in relation
to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations; or
(g) if a step in the manufacture of the goods (not being
therapeutic devices other than devices prescribed for the
purposes of this paragraph) has been carried out outside
Australia—the manufacturing and quality control procedures
used in the manufacture of the goods are not acceptable; or
(h) if the goods have been manufactured in Australia—the goods
have been manufactured contrary to Part 3-3; or
(j) if the goods have been manufactured in Australia, or
imported into Australia, solely for export—a relevant
authority of the country to which the goods are to be
exported has not confirmed its willingness to accept the
goods and:
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(i) the goods have been refused registration or listing for
supply in Australia; or
(ii) the Secretary requires such a confirmation for a reason
other than because the goods have been refused
registration or listing; or
(k) the goods do not comply with prescribed quality or safety
criteria; or
(m) the goods contain substances that are prohibited imports for
the purposes of the Customs Act 1901; or
(n) one or more of the manufacturers of the goods are not
nominated as manufacturers of the goods in the application.
(1AA) If:
(a) a medicine (the original medicine) is included in the Register
in relation to a person; and
(b) the person makes an application under section 23 for the
listing of a medicine (the new medicine) under this section;
and
(ba) the application complies with section 23C; and
(c) the Secretary is satisfied that paragraphs (1)(a) to (ba) are
satisfied in relation to the application; and
(d) the Secretary is satisfied that the new medicine has the same
characteristics as the original medicine apart from the
characteristics specified in an instrument under
subsection (1AB);
the Secretary may list the new medicine in relation to the person.
(1AB) The Minister may, by legislative instrument, specify characteristics
for the purposes of paragraph (1AA)(d).
(1A) To avoid doubt, if:
(a) an application is made for the listing of therapeutic goods in
relation to a person under section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
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(ii) a notice that a certificate under that subsection is not
required in relation to the application; and
(c) the other requirements in subsection (1) are met;
the Secretary must list the goods under subsection (1) without
inquiring into the correctness of the certificate or the notice.
(2) In making a decision for the purposes of paragraph (1)(g), the
matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country that is a member of the European Community
or a member of EFTA—an EC/EFTA attestation of
conformity in relation to the goods; or
(ia) if the goods are not therapeutic devices and a step in the
manufacture of the goods has been carried out in a
country declared by the Minister under section 3B to be
covered by a non-EC/EFTA MRA—a non-EC/EFTA
attestation of conformity, for the non-EC/EFTA MRA,
in relation to the goods; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the goods is of an acceptable standard;
and
(b) whether the applicant has agreed to provide, where the
Secretary considers inspection of the manufacturing
procedures used in the manufacture of the goods to be
necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) If therapeutic goods are exempt from the operation of Part 3-3 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to
the goods, as if paragraph (h) were omitted.
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(2B) If a person is exempt from the operation of Part 3-3 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has
effect, in relation to the goods, as if the reference in paragraph (h)
to Part 3-3 were a reference to that Part to the extent that it applies
to that person in relation to the manufacture of the goods.
(2C) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been
exempt from the operation of Part 3-3;
subsection (1) has effect, in relation to the goods, as if
paragraph (g) were omitted.
(2D) A decision for the purposes of paragraph (1)(g) may also take into
account any information provided to the Secretary by a health
authority of a Convention country and relating to:
(a) the general standards of manufacturing practice of a
particular manufacturer; or
(b) the specific standards of manufacture or control adopted by a
particular manufacturer in relation to particular goods.
(2E) For the purposes of subsection (2D), a Convention country is a
country that is a party to the Mutual Recognition Convention.
(2F) Information referred to in subsection (2D) and provided in
accordance with the Mutual Recognition Convention is to be
treated as equivalent to information obtained as a result of an
inspection under Part 3-3 of this Act.
(3) Where an application is made, the Secretary must notify the
applicant in writing of his or her decision on the application within
28 days of the making of the decision and, in the case of a decision
not to list the goods, of the reasons for the decision.
(4) As soon as practicable after an applicant has been informed that
therapeutic goods in respect of which an application was made are
acceptable for listing, the Secretary must give to the applicant a
certificate of listing of the goods, and the listing of the goods
commences on the day specified for the purpose in the certificate.
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26AA Listing of therapeutic device to which EC/EFTA attestation of
conformity applies
(1) If:
(a) an application is made under section 23 for the listing of a
therapeutic device in relation to a person; and
(aa) the application complies with section 23C; and
(b) the applicant gives to the Secretary an EC/EFTA attestation
of conformity as to the matters specified in paragraphs
26(1)(c) to (m) in relation to the device;
the Secretary must list the device in relation to the person unless
the Secretary considers that the device may compromise the health
or safety of users.
(2) The Secretary must notify the applicant in writing of his or her
decision within 28 days of the making of the decision. If the
Secretary decides not to list the device, the notice must contain the
reasons for that decision.
(3) If the Secretary decides to list the device, the Secretary must:
(a) include the device in the Register; and
(b) give to the applicant a certificate of listing.
(4) The listing of the device commences on the day specified for the
purpose in the certificate of listing.
26A Listing of certain medicines
(1) If:
(a) an application is made for the listing of medicine in relation
to a person under section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
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subsection is not required in relation to the application;
and
(c) the requirements of subsection (2) and (where applicable)
subsections (2A), (3) and (4A) have been complied with; and
(d) the medicine is not export only medicine; and
(e) the medicine is not one that has previously had its
registration or listing cancelled;
the Secretary must list the medicine in relation to the person.
(1A) To avoid doubt, if:
(a) an application is made for the listing of a medicine in relation
to a person in accordance with section 23; and
(aa) the application complies with section 23C; and
(b) the application is accompanied by either:
(i) the certificate required under subsection 26B(1); or
(ii) a notice that a certificate under that subsection is not
required in relation to the application; and
(c) the other requirements in subsection (1) are met;
the Secretary must list the medicine under subsection (1) without
inquiring into the correctness of the certificate or the notice.
(2) The applicant must certify that:
(a) the medicine is eligible for listing; and
(b) the medicine is safe for the purposes for which it is to be
used; and
(c) the presentation of the medicine is not unacceptable; and
(ca) the medicine does not contain an ingredient that is not
specified in a determination under paragraph 26BB(1)(a); and
(cb) if a determination under paragraph 26BB(1)(b) specifies
requirements in relation to ingredients being contained in the
medicine—none of the requirements have been contravened;
and
(d) the medicine conforms to every standard (if any) applicable
to the medicine; and
(da) both of the following are complied with in relation to the
medicine:
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(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(e) if the medicine has been manufactured in Australia—each
step in the manufacture of the medicine has been carried out
by a person who is the holder of a licence to carry out that
step; and
(f) the medicine complies with all prescribed quality or safety
criteria that are applicable to the medicine; and
(fa) the medicine’s specifications comply with any requirements
that are prescribed by the regulations for the purposes of this
paragraph and that are applicable to the medicine; and
(fb) the medicine’s label:
(i) complies with any requirements that are prescribed by
the regulations for the purposes of this subparagraph
and that are applicable to the medicine; and
(ii) does not make a claim that is inconsistent with any
claim made by the applicant in relation to the medicine
in, or in connection with, the application; and
(fba) if the medicine’s label contains one or more indications—
each indication:
(i) is covered by a determination under
paragraph 26BF(1)(a); and
(ii) is proposed to be accepted in relation to the inclusion of
the medicine in the Register; and
(fc) the applicant holds information or evidence showing the
medicine’s specifications will be maintained under the
conditions set out on the medicine’s label until the
medicine’s expiry date; and
(fd) each indication proposed to be accepted in relation to the
inclusion of the medicine in the Register is covered by a
determination under paragraph 26BF(1)(a); and
(fe) if a determination under paragraph 26BF(1)(b) specifies
requirements in relation to an indication proposed to be
accepted in relation to the inclusion of the medicine in the
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Register—none of the requirements have been contravened;
and
(g) the medicine does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(h) all the manufacturers of the medicine are nominated as
manufacturers in the application; and
(i) the applicant has, with manufacturers of the medicine who
are manufacturers of the prescribed kind, written agreements
containing such matters as are prescribed; and
(j) both:
(i) the applicant holds information or evidence to support
any claim (other than a claim that is an indication)
proposed to be accepted in relation to the inclusion of
the medicine in the Register; and
(ii) the information or evidence complies with any
requirements specified in a determination under
subsection (2B); and
(ja) both:
(i) the applicant holds information or evidence to support
each indication proposed to be accepted in relation to
the inclusion of the medicine in the Register; and
(ii) the information or evidence complies with any
requirements specified in a determination under
subsection (2B); and
(k) the information included in or with the application is correct.
(2A) The applicant must also certify any other matters prescribed by the
regulations for the purposes of this subsection.
(2B) The Minister may, by legislative instrument, specify requirements
for the purposes of subparagraph (2)(j)(ii) or (2)(ja)(ii).
(3) Subject to subsection (7), if a step in the manufacture of the
medicine has been carried out outside Australia, the Secretary must
have certified, prior to the application being made, that the
manufacturing and quality control procedures used in each such
step are acceptable.
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(4) In deciding whether so to certify for the purposes of subsection (3),
the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if a step in the manufacture of the medicine has been
carried out in a country that is a member of the
European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the
medicine; or
(ia) if a step in the manufacture of the medicine has been
carried out in a country declared by the Minister under
section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
(ii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the medicine is of an acceptable
standard; and
(b) whether the applicant has agreed to provide, if the Secretary
considers inspection of the manufacturing procedures used in
the manufacture of the medicine to be necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection; and
(c) whether the applicant has complied with any requirements
made by the Secretary under section 31 in relation to the
manufacture or preparation of the medicine.
(4A) If the medicine includes any ingredient of animal origin, the
Secretary must have certified, prior to the application being made,
that he or she is satisfied of the safety of the ingredient.
(5) If a medicine is exempt from the operation of Part 3-3 or a person
is exempt from the operation of that Part in relation to the
manufacture of the medicine, subsection (2) has effect, in relation
to the medicine, as if paragraph (2)(e) were omitted.
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(6) If a person (the manufacturer) is exempt from the operation of
Part 3-3 in relation to a step in the manufacture of a medicine,
subsection (2) has effect, in relation to the medicine, as if the
reference in paragraph (2)(e) to a person who is the holder of a
licence were a reference to the manufacturer to the extent that
Part 3-3 applies to the manufacturer in relation to the manufacture
of the medicine.
(7) If:
(a) a medicine was made outside Australia; and
(b) had the medicine been made in Australia, it would have been
exempt from the operation of Part 3-3;
subsection (3) does not apply in relation to the medicine.
(9) As soon as practicable after a medicine has been listed under this
section, the Secretary must give to the applicant a certificate of
listing of the medicine. The listing of the medicine commences on
the day specified for the purpose in the certificate.
26AB Application for listing of certain medicines following efficacy
evaluation
(1) If:
(a) an application is made under section 23 for the listing of
medicine in relation to a person; and
(b) the application passes preliminary assessment; and
(c) the requirements of subsections (2), (3), (4) and (6) have
been complied with; and
(d) the medicine is not a medicine which may be listed under
section 26A; and
(e) the medicine is not export only medicine; and
(f) the medicine is not one that has previously had its
registration or listing cancelled;
the Secretary must evaluate the medicine for listing under
section 26AE.
(2) The applicant must certify that:
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(a) the medicine is eligible for listing; and
(b) the medicine is safe for the purposes for which it is to be
used; and
(c) the presentation of the medicine is not unacceptable; and
(d) the medicine does not contain an ingredient that is not
specified in a determination under paragraph 26BB(1)(a); and
(e) if a determination under paragraph 26BB(1)(b) specifies
requirements in relation to ingredients being contained in the
medicine—none of the requirements have been contravened;
and
(f) the medicine conforms to every standard (if any) applicable
to the medicine; and
(g) both of the following are complied with in relation to the
medicine:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(h) if the medicine has been manufactured in Australia—each
step in the manufacture of the medicine has been carried out
by a person who is the holder of a licence to carry out that
step; and
(i) the medicine complies with all prescribed quality or safety
criteria that are applicable to the medicine; and
(j) the medicine’s specifications comply with any requirements
that are prescribed by the regulations for the purposes of this
paragraph and that are applicable to the medicine; and
(k) the medicine’s label:
(i) complies with any requirements that are prescribed by
the regulations for the purposes of this subparagraph
and that are applicable to the medicine; and
(ii) does not make a claim that is inconsistent with any
claim made by the applicant in relation to the medicine
in, or in connection with, the application; and
(l) the applicant holds information or evidence showing the
medicine’s specifications will be maintained under the
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conditions set out on the medicine’s label until the
medicine’s expiry date; and
(m) the applicant has available sufficient information to
substantiate each claim and each indication proposed to be
accepted in relation to the inclusion of the medicine in the
Register; and
(n) the medicine does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(o) all the manufacturers of the medicine are nominated as
manufacturers in the application; and
(p) the applicant has, with manufacturers of the medicine who
are manufacturers of the prescribed kind, written agreements
containing such matters as are prescribed; and
(q) the information included in or with the application is
complete and correct.
(3) The applicant must also certify any other matters prescribed by the
regulations for the purposes of this subsection.
(4) Subject to subsection (9), if a step in the manufacture of the
medicine has been carried out outside Australia, the Secretary must
have certified, prior to the application being made, that the
manufacturing and quality control procedures used in each such
step are acceptable.
(5) In deciding whether to certify for the purposes of subsection (4),
the matters that may be taken into account include:
(a) whether the applicant has provided:
(i) if a step in the manufacture of the medicine has been
carried out in a country that is a member of the
European Community or a member of EFTA—an
EC/EFTA attestation of conformity in relation to the
medicine; or
(ii) if a step in the manufacture of the medicine has been
carried out in a country declared by the Minister under
section 3B to be covered by a non-EC/EFTA MRA—a
non-EC/EFTA attestation of conformity, for the
non-EC/EFTA MRA, in relation to the medicine; or
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(iii) in any other case—an acceptable form of evidence from
a relevant overseas authority establishing that the
manufacture of the medicine is of an acceptable
standard; and
(b) whether the applicant has agreed to provide, if the Secretary
considers inspection of the manufacturing procedures used in
the manufacture of the medicine to be necessary:
(i) funds for the carrying out of that inspection by the
Department; and
(ii) evidence that the manufacturer has agreed to such an
inspection; and
(c) whether the applicant has complied with any requirements
made by the Secretary under section 31 in relation to the
manufacture or preparation of the medicine.
(6) If the medicine includes any ingredient of animal origin, the
Secretary must have certified, prior to the application being made,
that he or she is satisfied of the safety of the ingredient.
(7) If a medicine is exempt from the operation of Part 3-3 or a person
is exempt from the operation of that Part in relation to the
manufacture of the medicine, subsection (2) has effect, in relation
to the medicine, as if paragraph (2)(h) were omitted.
(8) If a person (the manufacturer) is exempt from the operation of
Part 3-3 in relation to a step in the manufacture of a medicine,
subsection (2) has effect, in relation to the medicine, as if the
reference in paragraph (2)(h) to a person who is the holder of a
licence were a reference to the manufacturer to the extent that
Part 3-3 applies to the manufacturer in relation to the manufacture
of the medicine.
(9) If:
(a) a medicine was made outside Australia; and
(b) had the medicine been made in Australia, it would have been
exempt from the operation of Part 3-3;
subsection (4) does not apply in relation to the medicine.
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26AC Evaluation fees for listing of medicine under section 26AE
(1) This section applies if:
(a) an application is made under section 23 in relation to a
medicine for listing under section 26AE; and
(b) the application has passed preliminary assessment.
(2) A fee (the evaluation fee) specified in or determined in accordance
with the regulations is payable by the applicant in respect of the
evaluation of a medicine for listing under section 26AE.
(3) The Secretary must notify each applicant of the amount of the
evaluation fee.
(4) The evaluation fee payable by an applicant:
(a) is due and payable on the day on which the applicant is
notified of the amount of the evaluation fee; and
(b) may be recovered by the Commonwealth as a debt due to the
Commonwealth.
(5) If:
(a) an application is made under section 23 in relation to a
medicine for listing under section 26AE; and
(b) the applicant has paid the whole of the evaluation fee; and
(c) regulations made for the purposes of paragraph 63(2)(daaaa)
prescribe a period within which evaluations under
section 26AE in relation to the medicine must be completed;
and
(d) the evaluation is completed, but not within that period;
then 25% of the evaluation fee must be refunded to the applicant.
(6) For the purposes of paragraph (5)(d), the evaluation is taken to be
completed when the applicant is notified of the Secretary’s
decision under subsection 26AE(3) in relation to the medicine.
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Section 26AD
26AD Lapsing and deemed refusal of applications for listing of
medicine under section 26AE
Lapsing of applications
(1) An application for the listing of a medicine under section 26AE
lapses if:
(a) any part of the evaluation fee referred to in section 26AC
remains unpaid at the end of 28 days after the day on which
the amount became due and payable; or
(b) the application contains information that is inaccurate or
misleading in a material particular; or
(c) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Deemed refusal of applications
(2) If:
(a) regulations made for the purposes of paragraph 63(2)(daaaa)
prescribe a period within which evaluations under
section 26AE in relation to the medicine must be completed;
and
(b) at the end of that period, the evaluation has not been
completed;
the applicant may give the Secretary written notice that the
applicant wishes to treat the application as having been refused.
(3) A notice under subsection (2) may be given at any time before the
evaluation is completed.
(4) If a notice has been given, this Act (except subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to list the medicine which is
the subject of the application; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
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(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (2).
26AE Evaluation and listing of certain medicines
Evaluation
(1) If:
(a) an application is made under section 23 for the listing of a
medicine in relation to a person under this section; and
(b) the application has passed preliminary assessment;
the Secretary must evaluate the medicine having regard to:
(c) whether the efficacy of the medicine for the purposes for
which it is to be used has been satisfactorily established; and
(d) such other matters (if any) as the Secretary considers
relevant.
(2) If a period in relation to which an evaluation under this section
must be completed has been prescribed under
paragraph 63(2)(daaaa), the evaluation must be completed within
that period.
Secretary must decide whether to list medicine
(3) After an evaluation under this section of goods has been
completed, the Secretary must decide:
(a) to list the medicine; or
(b) not to list the medicine.
Decision to list
(4) If the Secretary decides under subsection (3) to list the medicine,
the Secretary must, in accordance with subsection (5), notify the
applicant in writing of the decision within 28 days of making the
decision.
(5) The notice must:
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(a) set out the decision under subsection (3) to list the medicine
in relation to the person; and
(b) inform the applicant that the medicine will not be included in
the Register unless and until the applicant gives the
Secretary:
(i) the certificate required under subsection 26B(1); or
(ii) a notice (in accordance with a form approved, in
writing, by the Secretary) that a certificate under that
subsection is not required in relation to the application.
(6) If the applicant gives the Secretary the certificate referred to in
subparagraph (5)(b)(i) or the notice referred to in
subparagraph (5)(b)(ii), the Secretary must:
(a) include the medicine in the Register; and
(b) give the applicant a certificate of listing.
(7) To avoid doubt, if the applicant gives the Secretary the certificate
referred to in subparagraph (5)(b)(i) or the notice referred to in
subparagraph (5)(b)(ii), the Secretary must include the medicine in
the Register under paragraph (3)(a) without inquiring into the
correctness of the certificate or the notice.
Date listing commences
(8) The listing of the medicine commences on the day specified for the
purpose in the certificate.
Refusal to list medicine
(9) If:
(a) an application is made for the listing of medicine in relation
to a person; and
(b) the Secretary decides under subsection (3) not to list the
medicine;
the Secretary must notify the applicant in writing of the decision,
and the reasons for the decision, within 28 days of making the
decision.
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Section 26B
26B Certificates required in relation to patents
(1A) A certificate is required under subsection (1) in relation to an
application for registration or listing of therapeutic goods only if:
(a) the applicant is required to submit evidence or information to
establish the safety or efficacy of the goods as part of the
process of applying for registration or listing; and
(b) in order to satisfy that requirement, the applicant relies (in
whole or in part) on evidence or information that another
person submitted to the Secretary:
(i) to establish the safety or efficacy of other therapeutic
goods that have already been registered or listed; and
(ii) as part of the process of applying for the registration or
listing of those other goods.
(1) The certificate required under this subsection is either:
(a) a certificate to the effect that the applicant, acting in good
faith, believes on reasonable grounds that it is not marketing,
and does not propose to market, the therapeutic goods in a
manner, or in circumstances, that would infringe a valid
claim of a patent that has been granted in relation to the
therapeutic goods; or
(b) a certificate to the effect that:
(i) a patent has been granted in relation to the therapeutic
goods; and
(ii) the applicant proposes to market the therapeutic goods
before the end of the term of the patent; and
(iii) the applicant has given the patentee notice of the
application for registration or listing of the therapeutic
goods under section 23.
The certificate must be signed by, or on behalf of, the applicant and
must be in a form approved by the Secretary.
(2) A person commits an offence if:
(a) the person gives a certificate required under subsection (1);
and
(b) the certificate is false or misleading in a material particular.
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Penalty: 1,000 penalty units.
(3) For the purposes of this section, a patent is taken to have been
granted in relation to therapeutic goods if marketing the goods
without the authority of the patentee would constitute an
infringement of the patent.
(4) In this section:
patent has the same meaning as in the Patents Act 1990.
26BA Approved form for notices
An approval of a form for a notice for the purposes of
subsection 25AB(3), 26(1), 26A(1) or 26AE(5) may require or
permit the notice to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26BB Permissible ingredients
(1) The Minister may, by legislative instrument, make a determination
specifying either or both of the following:
(a) ingredients;
(b) for some or all of those ingredients—requirements in relation
to those ingredients being contained in medicine.
Note: A person seeking the listing of a medicine under section 26A or 26AB
must certify that:
(a) the medicine does not contain an ingredient that is not specified in the determination; and
(b) none of the requirements specified in the determination in relation to ingredients being contained in the medicine have been contravened.
Requirements
(2) The requirements referred to in paragraph (1)(b) may relate to
particular ingredients not being contained in particular medicine.
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(2A) The requirements referred to in paragraph (1)(b) may relate to a
particular ingredient being contained in particular medicine only in
the circumstances specified in the determination in relation to the
ingredient.
(3) The requirements referred to in paragraph (1)(b) may relate to
permitted concentrations or permitted total amounts of ingredients.
(4) Subsections (2), (2A) and (3) do not limit paragraph (1)(b).
(5) A determination under paragraph (1)(b) may make different
provision for different classes of medicine.
Limitations on determination under subsection (1)
(6) The Minister may, by legislative instrument, make a determination
specifying either or both of the following:
(a) ingredients that must not be specified under paragraph (1)(a);
(b) requirements that must not be specified under
paragraph (1)(b) in relation to ingredients being contained in
medicine.
(7) A determination under paragraph (6)(b) may make different
provision for different classes of medicine.
Incorporation of instruments
(8) Despite subsection 14(2) of the Legislation Act 2003, a
determination under this section may make provision in relation to
a matter by applying, adopting or incorporating any matter
contained in an instrument or other writing as in force or existing
from time to time.
26BC Variation of determination under section 26BB—Minister’s
initiative
The Minister may, on his or her own initiative and by legislative
instrument, vary a determination under section 26BB.
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Section 26BE
26BE Variation of section 26BB determination—application by
person
Making an application for recommendation
(1) A person may apply to the Secretary for a recommendation that the
Minister vary a section 26BB determination.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) set out the recommendation sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee (if any).
Further information about application for recommendation
(2A) The Secretary may, by written notice given to a person who has
made an application under subsection (1), require the person to:
(a) give the Secretary such further information in connection
with the application as is specified in the notice; and
(b) do so within such reasonable period as is specified in the
notice.
Lapsing of application for recommendation
(2B) An application made under subsection (1) lapses if:
(a) the application contains information that is inaccurate or
misleading in a material particular; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Decision by Secretary whether to make recommendation
(3) If:
(a) an application is made under subsection (1); and
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(b) any applicable prescribed evaluation fee has been paid; and
(c) if further information is required to be given under
subsection (2A) within a specified period—the information is
given within that period;
the Secretary must carry out an evaluation of whether to make the
recommendation.
(4) After carrying out the evaluation, the Secretary must:
(a) make the recommendation; or
(b) refuse to make the recommendation.
(5) In deciding whether to make the recommendation, the Secretary
must have regard to:
(a) the quality and safety of the ingredients concerned; and
(b) such other matters (if any) as the Secretary considers
relevant.
(5A) If the Secretary refuses to make the recommendation, the Secretary
must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
Partial refund of application fee in certain circumstances
(5B) If:
(a) an application fee is prescribed for the purposes of
paragraph (2)(d); and
(b) regulations made for the purposes of paragraph 63(2)(daaa)
prescribe a period within which recommendations under this
section must be made; and
(c) the Secretary makes a recommendation in relation to an
application under subsection (1), but not within that period;
then 25% of the application fee must be refunded to the applicant.
Deemed refusal of applications in certain circumstances
(5C) If:
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(a) regulations made for the purposes of paragraph 63(2)(daaa)
prescribe a period within which recommendations under this
section must be made; and
(b) at the end of that period, the Secretary has not made a
recommendation in relation to an application under
subsection (1);
the applicant may give the Secretary written notice that the
applicant wishes to treat the application as having been refused.
(5D) A notice under subsection (5C) may be given at any time before
the recommendation in relation to the application is made.
(5E) If a notice has been given under subsection (5C), this Act (except
subsection 60(5)) has effect as if:
(a) the Secretary had decided not to make a recommendation
under this section; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary under subsection (5C).
Minister may vary determination
(6) If the Secretary makes a recommendation under paragraph (4)(a),
the Minister must:
(a) by legislative instrument, vary the section 26BB
determination; or
(b) refuse to vary the section 26BB determination.
(7) In making a decision under subsection (6), the Minister must have
regard to:
(a) the recommendation made under paragraph (4)(a); and
(b) such other matters (if any) as the Minister considers relevant.
Applications or information may be given electronically
(9) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (2A), may require or permit an application
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Section 26BF
or information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26BF Permissible indications
(1) The Minister may, by legislative instrument, make a determination
in relation to either or both of the following:
(a) indications;
(b) requirements in relation to indications.
Note: See paragraphs 26A(2)(fba), (fd) and (fe) (which deal with matters
that a person seeking the listing of a medicine under section 26A must
certify).
(2) In deciding whether to make a determination under subsection (1)
in relation to a particular indication, the Minister may have regard
to whether the indication is a therapeutic use that relates to one or
more of the following:
(a) maintaining health;
(b) enhancing health;
(c) preventing a dietary deficiency;
(d) a disease, ailment, defect or injury, other than a serious form
of the disease, ailment, defect or injury.
(3) Subsection (2) does not limit the matters to which the Minister may
have regard in deciding whether to make a determination under
subsection (1) in relation to a particular indication.
(4) Without limiting paragraph (1)(b), the requirements may relate to:
(a) the use of particular indications in specified circumstances;
or
(b) the use of particular indications if certain specified conditions
are met.
(5) A determination under paragraph (1)(b) may make different
provision for different classes of medicines.
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26BG Limitations on determination under section 26BF
(1) The Minister may, by legislative instrument, make a determination
specifying indications that must not be covered by a determination
under paragraph 26BF(1)(a).
(2) The determination may specify an indication either generally or in
relation to specified circumstances.
(3) The Minister may, by legislative instrument, vary or revoke a
determination under subsection (1).
26BH Variation of determination under section 26BF—Minister’s
initiative
The Minister may, on his or her own initiative and by legislative
instrument, vary a determination under section 26BF.
26BJ Variation of determination under section 26BF—application
by person
Application for recommendation to vary section 26BF
determination
(1) A person may apply to the Secretary for a recommendation that the
Minister vary a determination under section 26BF.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved, in writing, by
the Secretary; and
(b) set out the recommendation sought; and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee (if any).
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Limits on kinds of applications that can be made
(3) A person cannot make an application under subsection (1) for a
recommendation the effect of which would be for the
determination to cover any of the following:
(a) an indication specified in a determination under
section 26BG;
(b) an indication that is or contains a restricted representation
(within the meaning of Part 5-1);
(c) unless subsection (4) applies—an indication that is or
contains a prohibited representation (within the meaning of
Part 5-1);
(d) unless subsection (5) applies—an indication that refers to
preventing, curing or alleviating a disease, ailment, defect or
injury.
(4) For the purposes of paragraph (3)(c), this subsection applies if:
(a) the indication is a therapeutic use that relates to sun
protection; and
(b) the prohibited representation relates to the prevention of skin
cancer; and
(c) the use of the prohibited representation is permitted under
section 42DK.
(5) For the purposes of paragraph (3)(d), this subsection applies if the
indication refers to:
(a) the prevention of a dietary deficiency; or
(b) the prevention of skin cancer or sun damage.
Further information about application for recommendation
(6) The Secretary may, by written notice given to a person who has
made an application under subsection (1), require the person to:
(a) give the Secretary such further information in connection
with the application as is specified in the notice; and
(b) do so within such reasonable time as is specified in the
notice.
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Lapsing of application for recommendation
(7) An application made under subsection (1) lapses if:
(a) the application contains information that is inaccurate or
misleading in a material particular; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application is inaccurate or
misleading in a material particular.
Decision on application for recommendation
(8) If:
(a) an application is made under subsection (1); and
(b) any applicable prescribed application fee has been paid; and
(c) if further information is required to be given under
subsection (6) within a specified time—the information is
given within that time;
the Secretary must decide whether to make the recommendation or
refuse to make the recommendation.
(9) In deciding whether to make the recommendation, the Secretary
may have regard to whether the indication to which the application
relates is a therapeutic use that relates to one or more of the
following:
(a) maintaining health;
(b) enhancing health;
(c) preventing a dietary deficiency;
(d) a disease, ailment, defect or injury, other than a serious form
of the disease, ailment, defect or injury;
(e) sun protection.
(10) If the Secretary refuses to make the recommendation, the Secretary
must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
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Minister may vary section 26BF determination
(11) If the Secretary makes a recommendation under subsection (8), the
Minister must:
(a) by legislative instrument, vary the determination under
subsection 26BF(1); or
(b) refuse to vary the determination.
(12) In deciding whether to vary a determination under
subsection 26BF(1) to include an indication not already covered by
the determination, the Minister may have regard to:
(a) the recommendation made under subsection (8) of this
section; and
(b) whether the indication is a therapeutic use that relates to one
or more of the matters in paragraphs (9)(a) to (e) of this
section.
(13) Subsection (12) does not limit the matters to which the Minister
may have regard in deciding whether to vary the determination.
Applications or information may be given electronically
(14) An approval of a form mentioned in paragraph (2)(a), or a notice
mentioned in subsection (6), may require or permit an application
or information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
26C Certificates required in relation to patent infringement
proceedings
(1) This section applies if:
(a) a person gives a certificate required under subsection 26B(1)
in relation to therapeutic goods; and
(b) another person (the second person) intends to commence
proceedings under the Patents Act 1990 against the person
referred to in paragraph (1)(a) for infringement of a patent
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that has been granted in relation to the therapeutic goods (the
proceedings).
(2) The second person, before the date upon which the proceedings are
commenced, must give to the Secretary and to the person referred
to in paragraph (1)(a) the certificate required by subsection (3).
(3) The certificate required by this subsection is a certificate to the
effect that the proceedings:
(a) are to be commenced in good faith; and
(b) have reasonable prospects of success; and
(c) will be conducted without unreasonable delay.
The certificate must be signed by, or on behalf of, the second
person and must be in a form approved by the Secretary.
(4) For the purpose of paragraph (3)(b), proceedings have reasonable
prospects of success if:
(a) the second person had reasonable grounds in all the
circumstances known to the second person, or which ought
reasonably to have been known to the second person (in
addition to the fact of grant of the patent), for believing that
he or she would be entitled to be granted final relief by the
court against the person referred to in paragraph (1)(a) for
infringement by that person of the patent; and
(b) the second person had reasonable grounds in all the
circumstances known to the second person, or which ought
reasonably to have been known to the second person (in
addition to the fact of grant of the patent), for believing that
each of the claims, in respect of which infringement is
alleged, is valid; and
(c) the proceedings are not otherwise vexatious or unreasonably
pursued.
(5) The person referred to in paragraph (1)(a), with leave of the court,
or the Attorney-General, may apply to a prescribed court for an
order that the second person pay to the Commonwealth a pecuniary
penalty if the second person gives a certificate required under
subsection (3) and:
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(a) the certificate is false or misleading in a material particular;
or
(b) the second person breaches an undertaking given in the
certificate.
(5A) A pecuniary penalty ordered under subsection (5) must not exceed
$10,000,000.
(6) When determining the extent of a pecuniary penalty to be ordered
pursuant to subsection (5), the court must take into account:
(a) any profit obtained by the second person; and
(b) any loss or damage suffered by any person;
by reason of the second person exploiting the patent during the
proceedings.
(7) For the avoidance of doubt, subsection (6) does not limit the
matters the court may take into account when determining a
pecuniary penalty ordered pursuant to subsection (5).
(8) If:
(a) the second person has sought and obtained in the proceedings
an interlocutory injunction restraining the person referred to
in paragraph (1)(a) from infringing a patent; and
(b) section 26D does not apply; and
(c) a prescribed court declares that the second person has given a
certificate required under subsection (3); and
(d) a prescribed court declares that:
(i) the certificate is false or misleading in a material
particular; or
(ii) the second person has breached an undertaking given in
the certificate;
the prescribed court may, pursuant to this section, order that the
second person pay to the Commonwealth, a State or a Territory
compensation for any damages sustained or costs incurred by the
Commonwealth, a State or a Territory as a result of the grant of the
interlocutory injunction.
(9) In this section:
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prescribed court has the same meaning as in the Patents Act 1990.
26D Requirements for interlocutory injunction
(1) This section applies where:
(a) an applicant gives notice to a patentee in accordance with
subparagraph 26B(1)(b)(iii); and
(b) the patentee and/or its exclusive licensee (in this section the
party or parties is or are referred to as the patentee) applies to
a prescribed court for an interlocutory injunction to restrain
the applicant from marketing the therapeutic goods the
subject of the application on the ground that such conduct
will constitute an infringement of its patent.
(2) An application for interlocutory relief in accordance with
subsection (1) may not be instituted unless the patentee has first
notified the Attorney-General of the Commonwealth, or of a State
or of a Territory, in writing of the application.
(3) The Attorney-General of the Commonwealth shall be deemed to be
a party to any proceedings commenced in accordance with
subsection (1) unless the Attorney-General gives written notice to
the prescribed court that he or she does not desire to be a party.
(4) If an interlocutory injunction is granted pursuant to an application
made as described in subsection (1) and:
(a) the patentee subsequently discontinues the principal
proceedings without the consent of the other parties thereto;
or
(b) the principal proceedings are dismissed; and
(c) in either case, the prescribed court declares that:
(i) the patentee did not have reasonable grounds, in all the
circumstances known to the patentee or which ought
reasonably have been known to the patentee:
(A) to believe that it would be granted final relief
by the prescribed court against the applicant
referred to in paragraph (1)(a) for infringement
by that person of the patent; or
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Section 26D
(B) (in addition to the fact of grant of the patent),
for believing that each of the claims, in respect
of which infringement is alleged in the
proceedings, would have a reasonable prospect
of being held to be valid if challenged by the
applicant referred to in paragraph (1)(a); or
(ii) the application for the interlocutory injunction was
otherwise vexatious or not reasonably made or pursued;
the prescribed court may, in addition to any other relief which it
believes should be granted to any person, make any of the orders
described in subsection (5).
(5) If the prescribed court makes a declaration pursuant to
paragraph (4)(c), the prescribed court may, pursuant to the usual
undertaking as to damages given by the patentee to the prescribed
court to obtain the interlocutory injunction:
(a) assess and award compensation to the applicant referred to in
paragraph (1)(a) against whom the interlocutory injunction
was made:
(i) on the basis of an account of the gross profits of the
patentee arising from the sale by it in Australia of the
therapeutic goods the subject of the interlocutory
injunction, during the period of the interlocutory
injunction, without requiring the said applicant to
establish or quantify its actual loss; or
(ii) on such other basis as the court determines to be
appropriate; and
(b) award to the Commonwealth compensation for any damages
sustained, or costs incurred, by it as a result of the grant of
the interlocutory injunction; and
(c) award to a State or a Territory compensation for any damages
sustained, or costs incurred, by it as a result of the grant of
the interlocutory injunction.
(6) In this section:
prescribed court has the same meaning as in the Patents Act 1990.
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27 Registration or listing number
(1) Where the Secretary includes therapeutic goods (other than
grouped therapeutic goods) in the Register, the Secretary is to
assign a unique registration or listing number to the goods.
(2) Where the Secretary includes grouped therapeutic goods in the
Register, the Secretary is to assign a single, unique registration or
listing number to the grouped therapeutic goods.
28 Conditions of registration or listing
(1) The registration or listing of therapeutic goods is subject to the
conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination
setting out conditions for the purposes of subsection (1), being
conditions that relate to:
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the goods;
or
(c) the keeping of records relating to the goods; or
(d) matters dealt with in, or matters additional to matters dealt
with in, standards applicable to the goods; or
(e) such other matters relating to the goods as the Minister thinks
appropriate.
(2A) Without limiting subsection (2), different conditions may be
specified for:
(a) the registration of therapeutic goods; and
(aa) the provisional registration of medicine; and
(b) the listing of therapeutic goods; and
(c) different classes of therapeutic goods.
(2B) If the Secretary includes therapeutic goods in the Register in
relation to a person, the Secretary may, by notice in writing given
to the person, impose conditions on the registration or listing of
those goods.
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(3) The Secretary may, by notice in writing given to the person in
relation to whom therapeutic goods are registered or listed, impose
new conditions on the registration or listing or vary or remove
conditions imposed under subsection (2B) or this subsection.
(3A) The Secretary’s power under subsection (3) may be exercised at
the request of the person concerned or of the Secretary’s own
motion. A request must be accompanied by the prescribed fee.
(4) The imposition or variation or removal of a condition under
subsection (3) takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 28 days
after the notice is given to the person, unless the person has
agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 28 days after the notice is given to the person, unless the
person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 28 days after the notice is
given to the person.
(4A) For the purposes of paragraphs (4)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
(5) In addition to any conditions imposed under subsection (1), (2B) or
(3), the registration or listing of therapeutic goods (the subject
goods) is subject to the conditions that the person in relation to
whom the subject goods are registered or listed will:
(aa) not supply a batch of the subject goods in Australia, or export
a batch of the subject goods from Australia, after the expiry
date for the goods; and
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(ab) not, by any means, advertise the subject goods for an
indication other than those accepted in relation to the
inclusion of the goods in the Register; and
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises at which the
person deals with the subject goods, complies with
record-keeping requirements covered by paragraph (c)
or (ca), or keeps documents that relate to the subject
goods; and
(ii) while on those premises, to inspect those premises and
any therapeutic goods on those premises and to
examine, take measurements of, conduct tests on or take
samples of any therapeutic goods on those premises or
any thing on those premises that relates to any
therapeutic goods; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(iv) while on those premises, to inspect, and make copies of,
any records kept in compliance with paragraph (c) or
(ca); and
(v) while on those premises, to inspect, and make copies of,
any documents that relate to the subject goods; and
(b) if requested to do so by an authorised person, produce to the
person such documents relating to the subject goods as the
person requires and allow the person to copy the documents;
and
(c) in relation to each batch of the subject goods—keep a record,
at least until the end of the period of 12 months after the
expiry date for the goods, of all of the manufacturers
involved in the manufacture of that batch; and
(ca) comply, in relation to the subject goods, with any
record-keeping requirements that are prescribed; and
(d) if requested to do so by an authorised person, make any
record kept in compliance with paragraph (c) or (ca)
available to the authorised person for inspection:
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(i) at or before the time the authorised person requests, or
(if the authorised person requests) immediately; and
(ii) either in electronic form or in paper form, as the
authorised person requests; and
(e) comply, in relation to the subject goods, with any reporting
requirements that are prescribed; and
(f) if a manufacturer who was not nominated as a manufacturer
of the subject goods in the application for the registration or
listing of the goods becomes a manufacturer of the goods—
inform the Secretary in writing of that fact, no later than 10
working days after the manufacturer becomes a manufacturer
of the goods; and
(g) if premises that were not nominated as premises to be used in
the manufacture of the subject goods in the application
become premises used in the manufacture of the goods—
inform the Secretary in writing of that fact, no later than 10
working days after the premises are first used for that
purpose; and
(h) deliver a reasonable number of samples of the subject goods
if the Secretary so requests:
(i) within the period specified in the request (which must
include at least 10 working days); and
(ii) in accordance with any other requirements specified in
the request; and
(i) comply, in relation to the subject goods, with a notice given
to the person under subsection 25AA(1B).
(5B) The listing of a medicine under section 26A or 26AE is subject to a
condition that:
(a) each step in the manufacture of the medicine that is carried
out in Australia is carried out by a person who is the holder
of a licence to carry out that step or who is exempt from the
operation of Part 3-3 in relation to that step; and
(b) each step in the manufacture of the medicine that is carried
out outside Australia is the subject of a certification in force
under subsection 26A(3), 26AB(4) or 28A(2).
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(5C) Subsection (5B) does not apply if the medicine is exempt from the
operation of Part 3-3.
(6) If in, or in connection with, an application for the listing of
therapeutic goods, a claim (other than a claim that is an indication)
is made by the applicant in relation to the goods, the listing of the
goods is subject to the following conditions:
(a) a condition that the sponsor of the goods had, at the time
when the claim was made, information or evidence that
supported the claim and complied with the requirements (if
any) specified in a determination made under
subsection 26A(2B);
(b) a condition that the sponsor retains the information or
evidence at all times while the goods remain listed;
(c) a condition that, at any time while the goods remain listed,
the sponsor will, if asked to do so by the Secretary, give the
information or evidence to the Secretary.
(7) If:
(a) a medicine is listed under section 26A; and
(b) an indication is accepted in relation to the inclusion of the
medicine in the Register;
the listing of the medicine is subject to the following conditions:
(c) a condition that the person in relation to whom the medicine
is listed has, at all times while the medicine remains listed,
information or evidence that supports the indication and
complies with the requirements (if any) specified in a
determination under subsection 26A(2B);
(d) a condition that, at any time while the medicine remains
listed, the person will, if asked to do so by the Secretary, give
the information or evidence to the Secretary.
(8) If:
(a) a medicine is listed under section 26AE; and
(b) an indication is accepted in relation to the inclusion of the
medicine in the Register;
the listing of the medicine is subject to the following conditions:
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(c) a condition that the person in relation to whom the medicine
is listed has, at all times while the medicine remains listed,
information or evidence that supports the indication;
(d) a condition that, at any time while the medicine remains
listed, the person will, if asked to do so by the Secretary, give
the information or evidence to the Secretary.
28A Certification of manufacturing steps outside Australia following
application for listing
(1) The person in relation to whom medicine is listed under
section 26A or 26AE may apply to the Secretary for a certification
under this section of a step in the manufacture of the medicine that
is to be carried out outside Australia.
Note: The listing of medicine is subject to the condition that each step in the
manufacture of the medicine that is carried out outside Australia is the
subject of a certification in force under subsection 26A(3) or
subsection (2) of this section: see subsection 28(5B).
(2) If an application is made to the Secretary under this section, the
Secretary may, by writing, certify that the manufacturing and
quality control procedures used in that step are acceptable. The
Secretary must give the person written notice of the certification.
(3) In deciding whether to give the certification:
(a) subsection 26A(4) applies in a way corresponding to the way
in which it applies for the purposes of subsection 26A(3); and
(b) subsection 26AB(5) applies in a way corresponding to the
way in which it applies for the purposes of
subsection 26AB(4).
29 Duration of registration or listing
(1) Subject to this section, if goods are included in the Register in
relation to a person, the goods remain so included until their
registration or listing is cancelled under this Part.
Note: The goods are taken not to be included in the Register while their
registration or listing is suspended: see section 29G.
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Provisionally registered medicine
(2) If:
(a) a person makes an application for provisional registration of
a medicine; and
(b) in relation to that application, the Secretary decides under
subsection 25(3) to register the medicine; and
(c) the medicine is included in the Register in relation to the
person;
then:
(d) the medicine is provisionally registered; and
(e) the medicine remains included in the Register for the
provisional registration period, unless the medicine’s
registration is cancelled under this Part earlier.
Note: The medicine is taken not to be included in the Register while its
registration is suspended: see section 29G.
(3) Subject to this section, the provisional registration period is the 2
years starting on the day the registration commences.
Note: Subsection 25AB(6) provides that registration commences on the day
specified in the certificate of registration.
Extension of provisional registration upon application
(4) The person in relation to whom the medicine is provisionally
registered may make an application to the Secretary to extend the
provisional registration period.
(5) The application must:
(a) be in a form approved, in writing, by the Secretary; and
(b) contain the information that the form requires, and any
further information, statement or document the Secretary
requires, whether in the form or otherwise; and
(c) be made at least 6 months before the provisional registration
of the medicine is due to end; and
(d) be accompanied by the prescribed application fee.
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(6) On receiving the application, the Secretary must decide to grant, or
to refuse to grant, an extension of the provisional registration
period. In making that decision, the Secretary must have regard to:
(a) whether the Secretary is satisfied with the applicant’s plan to
submit comprehensive clinical data on the safety and efficacy
of the medicine before the end of the 6 years starting on the
day the provisional registration commenced; and
(b) such other matters (if any) as the Secretary considers
relevant.
(7) As soon as practicable after making the decision, the Secretary
must:
(a) give the applicant written notice of the decision; and
(b) if the Secretary decides to extend the provisional registration
period—specify in the notice the period of the extension
(which must not exceed 2 years and may be less than the
period sought by the applicant); and
(c) if the Secretary refuses to extend the provisional registration
period—set out the reasons for the refusal in the notice.
Note: At the time of granting an extension, the Secretary may impose new
conditions on the provisional registration or vary the existing
conditions: see subsection 28(3).
(8) No more than 2 extensions may be granted on applications under
subsection (4).
Note: Under subsection (9) the Secretary may extend the provisional
registration period on his or her own initiative.
Effect on provisional registration of later section 23 application
(9) If:
(a) before the provisional registration period ends, the person in
relation to whom the medicine is provisionally registered
makes an application under section 23 for registration of the
medicine; and
(b) the application is for the medicine to be included in the part
of the Register for goods known as registered goods;
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then the Secretary may, in connection with the application, end or
extend the provisional registration period as the Secretary
considers appropriate.
Note: At the time of granting an extension, the Secretary may impose new
conditions on the provisional registration or vary the existing
conditions: see subsection 28(3).
(10) In ending or extending, under subsection (9), the provisional
registration period:
(a) the Secretary must have regard to any matters prescribed by
the regulations for the purposes of this paragraph; and
(b) the Secretary must ensure the provisional registration period
continues while the Secretary is considering the application,
unless the medicine’s registration is cancelled under this Part;
and
(c) the Secretary must not extend the provisional registration
period so it would end more than 6 years after the provisional
registration commenced, unless the extension is for the
purposes of paragraph (b).
29A Criminal offence for failing to notify adverse effects etc. of
goods
(1) As soon as a person in relation to whom therapeutic goods are
registered or listed becomes aware of information of a kind
mentioned in subsection (2) relating to the goods, the person must
give the information to the Secretary in writing.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information that contradicts information already furnished by
the person under this Act;
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(b) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(c) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as the application for registration or listing of
the goods or information already furnished by the person
under this Act suggests;
(d) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
29AA Civil penalty for failing to notify adverse effects etc. of goods
(1) A person contravenes this section if:
(a) therapeutic goods are registered or listed in relation to a
person; and
(b) the person becomes aware of information of a kind
mentioned in subsection (2) relating to the goods; and
(c) the person does not give the information to the Secretary in
writing as soon as he or she becomes aware of it.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
(2) The information with which subsection (1) is concerned is
information of the following kinds:
(a) information that contradicts information already given by the
person under this Act;
(b) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(c) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as the application for registration or listing of
the goods or information already given by the person under
this Act suggests;
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(d) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
29B Notification of adverse effects etc. where application withdrawn
or lapses
(1) If an application for registration or listing of goods is withdrawn or
lapses, the Secretary may give the applicant written notice
requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is
aware of any information of a kind mentioned in
subsection 29A(2) or 29AA(2) relating to the goods; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) Notice under subsection (1) may be given within 14 days after an
application is withdrawn or lapses.
(3) A person must comply with the requirements of a notice under
subsection (1) within 30 days after the notice is given to the
person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person must not, in purported compliance with a notice under
subsection (1), give information that is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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29C Civil penalties for failing to notify adverse effects etc. where
application withdrawn or lapses
Civil penalty for failing to comply with requirements of a notice
(1) A person contravenes this subsection if the person does not comply
with the requirements of a notice under subsection 29B(1) within
30 days after the day on which the notice is given to the person.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Civil penalty for giving false or misleading information in
purported compliance with requirements of a notice
(2) A person contravenes this subsection if the person, in purported
compliance with a notice under subsection 29B(1), gives
information that is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
29D Suspension of registration or listing
(1) The Secretary may, by written notice given to a person in relation
to whom therapeutic goods are included in the Register, suspend
the registration or listing of the goods if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the therapeutic goods continue to be
included in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the therapeutic goods would not cause a
potential risk of death, serious illness or serious injury if
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the therapeutic goods were to continue to be included in
the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the registration or listing of the goods under
paragraph 30(1)(da), (e), (ea), (f), (fa), (fb) or (g) or
subsection 30(1A), (1C), (1D) or (2).
Notice of proposed suspension in some cases
(2) However, before suspending the registration or listing of the goods
because of paragraph (1)(b), the Secretary must:
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(3) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
Period of suspension
(4) A notice under subsection (1) must specify the period of the
suspension. The period must not exceed 6 months.
Note: Section 29E deals with when the suspension takes effect and
extensions of the suspension.
Publication
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
suspension.
29E When suspension takes effect etc.
(1) A suspension under section 29D takes effect:
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(a) if the notice under subsection 29D(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 29F; or
(b) the end of:
(i) the period specified in the notice under
subsection 29D(4); or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Extension of suspension
(3) The Secretary may, by written notice given to the person, extend
the period specified in the notice under subsection 29D(4) by a
further specified period not exceeding 6 months.
Publication
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
extension.
29F Revocation of suspension
(1) The Secretary must revoke a suspension under section 29D, by
written notice given to the person in relation to whom the
therapeutic goods are included in the Register, if the Secretary is
satisfied that:
(a) the ground on which the registration or listing of the
therapeutic goods was suspended no longer applies; and
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(b) there are no other grounds for suspending the registration or
listing of the therapeutic goods.
(2) The Secretary’s power to revoke the suspension may be exercised:
(a) if the person in relation to whom the therapeutic goods are
included in the Register applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
Publication
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
revocation.
Notice of refusal to revoke suspension
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
29G Effect of suspension
(1) If the registration or listing of therapeutic goods is suspended under
section 29D, the goods are taken, for the purposes of this Act
(other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to
be included in the Register while the suspension has effect.
Note: Dealing in therapeutic goods that are not included in the Register may
be an offence or may contravene a civil penalty provision: see
Division 1.
(2) While the suspension has effect, the Secretary’s power under
section 30 to cancel the registration or listing of the therapeutic
goods is not affected.
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30 Cancellation of registration or listing
(1) The Secretary may, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration or listing of the goods if:
(a) it appears to the Secretary that failure to cancel the
registration or listing would create an imminent risk of death,
serious illness or serious injury; or
(b) the goods become exempt goods; or
(c) the person requests in writing the cancellation of the
registration or listing; or
(d) the goods contain substances that are prohibited imports for
the purposes of the Customs Act 1901; or
(da) the person has refused or failed to comply with the condition
to which the inclusion of the goods is subject under
paragraph 28(5)(d):
(i) if the person was requested under that paragraph to
make the record in question available at or before a
requested time—before the end of the period of 24
hours after that time; or
(ii) if the person was requested under that paragraph to
make the record in question available immediately—
within 24 hours after the request was made; or
(e) in the case of a medicine listed under section 26A, it appears
to the Secretary that any of the certifications under
paragraph 26A(2)(a), (ca), (cb), (e), (fba), (fd), (fe) or (g) are
incorrect or (if applicable) the requirements under
subsection 26A(3) or (4A) are not fulfilled; or
(ea) in the case of a medicine listed under section 26AE, it
appears to the Secretary that any of the certifications under
paragraph 26AB(2)(a), (d), (e), (h) or (n) are incorrect or (if
applicable) the requirements under subsection 26AB(4) or (6)
are not fulfilled; or
(f) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the goods and the Secretary is
satisfied that the contravention is significant; or
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(fa) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
goods and the Secretary is satisfied that the contravention is
significant; or
(fb) there is a breach, involving the goods, of an applicable
provision of the Therapeutic Goods Advertising Code or any
other requirement relating to advertising applicable under
Part 5-1 or under the regulations, and the Secretary is
satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the goods is
misleading to a significant extent; or
(g) the Secretary is satisfied that a statement made in, or in
connection with, the application for registration or listing of
the goods was false or misleading in a material particular; or
(h) the annual registration or listing charge is not paid within 28
days after it becomes payable.
(1AA) Paragraph (1)(fb) does not apply to medicines that are
manufactured in Australia for export only, or are imported into
Australia for export only.
(1A) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26A or 26AE,
cancel the listing of the medicine if:
(a) the medicine is not eligible for listing; or
(b) the medicine is exempt.
(1C) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26A, cancel the
listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice
requiring the person to give to the Secretary information or
documents relating to the medicine; and
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(b) the notice is given for the purposes of ascertaining whether
any of the certifications by the person under
subsection 26A(2) or (2A) in relation to the medicine are
incorrect; and
(c) the person fails to comply with the notice within 20 working
days after the notice is given.
(1D) The Secretary may, by notice in writing given to a person in
relation to whom a medicine is listed under section 26AE, cancel
the listing of the medicine if:
(a) the Secretary, under section 31, gives to the person a notice
requiring the person to give to the Secretary information or
documents relating to the medicine; and
(b) the notice is given for the purposes of ascertaining whether
any of the certifications by the person under
subsection 26AB(2) or (3) in relation to the medicine are
incorrect; and
(c) the person fails to comply with the notice within 20 working
days after the notice is given.
(2) Subject to subsection (3), the Secretary may, by notice in writing
given to a person in relation to whom therapeutic goods are
included in the Register, cancel the registration or listing of the
goods if:
(a) it appears to the Secretary that the quality, safety or efficacy
of the goods is unacceptable; or
(aa) it appears to the Secretary that the presentation of the goods:
(i) in the case of registered goods—is not acceptable; or
(ii) in the case of listed goods—is unacceptable; or
(b) the goods have changed so that they have become separate
and distinct from the goods as so included; or
(ba) in the case of a medicine listed under section 26A, it appears
to the Secretary that any of the certifications under
paragraph 26A(2)(b), (c), (d), (da), (f), (fa), (fb), (fc), (h), (i),
(j), (ja) or (k) or subsection 26A(2A) are incorrect; or
(bab) in the case of a medicine listed under section 26AE, it
appears to the Secretary that any of the certifications under
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paragraph 26AB(2)(b), (c), (f), (g), (i), (j), (k), (l), (m), (o),
(p) or (q) or subsection 26AB(3) are incorrect; or
(c) the sponsor has refused or failed to comply with a condition
to which the inclusion of the goods is subject (other than the
condition under paragraph 28(5)(d)); or
(caa) all of the following subparagraphs apply:
(i) the Secretary gives the person a notice under section 31
that requires the person to give to the Secretary
information, or to produce to the Secretary documents,
relating to the goods;
(ii) subsection (1C) of this section does not apply to the
notice;
(iii) the person fails to comply with that notice within a
further 14 days after the end of the period specified in
that notice; or
(ca) the person has contravened subsection 29A(1) or 29AA(1) in
relation to the goods; or
(d) the goods become required to be included in the other part of
the Register; or
(e) the goods do not conform to a standard applicable to the
goods; or
(eaa) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the goods; or
(eab) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
goods; or
(ea) either of the following has not been complied with in relation
to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations.
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(3) Where the Secretary proposes to cancel the registration or listing of
goods in relation to a person under subsection (2), the Secretary
must:
(a) inform the person in writing that the Secretary proposes to
cancel that registration or listing and set out the reasons for
that proposed action; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
action.
(4) Where a person makes submissions in accordance with
paragraph (3)(b), the Secretary is not to make a decision relating to
the cancellation until the Secretary has taken the submissions into
account.
(4A) The Secretary must, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register,
cancel the registration of the goods if the Secretary becomes aware
that protected information was used when evaluating the goods for
registration.
(5) Where the Secretary cancels the registration or listing of goods in
relation to a person, the goods cease to be registered or listed:
(a) if the cancellation is effected under subsection (1), (1A), (1C)
or (1D)—on the day on which the notice of cancellation is
given to the person; or
(b) in any other case—on the day specified in the notice, which
must be at least 20 working days after the notice is given to
the person.
30A Revocation of cancellation of registration or listing upon
request
(1) If:
(a) the Secretary cancels the registration or listing of therapeutic
goods because of the request of a person made under
paragraph 30(1)(c); and
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(b) before the end of the period of 90 days beginning on the day
the goods ceased to be registered or listed, the person
requests, in writing, the Secretary to revoke the cancellation;
and
(c) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
30AA Revocation of cancellation of registration or listing—payment
of annual registration or listing charge
(1) If:
(a) the Secretary cancels the registration or listing of therapeutic
goods because the annual registration or listing charge was
not paid within 28 days after it became payable (see
paragraph 30(1)(h)); and
(b) before the end of the period of 90 days beginning on the day
the goods ceased to be registered or listed, the person
requests, in writing, the Secretary to revoke the cancellation;
and
(c) the annual registration or listing charge has been paid; and
(d) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
30B Publication of cancellation of registration or listing
If the Secretary cancels the registration or listing of therapeutic
goods under section 30, the Secretary must, as soon as practicable
after the cancellation, cause to be published in the Gazette, or on
the Department’s website, a notice setting out particulars of the
cancellation.
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Section 30C
30C Consultation with Gene Technology Regulator
(1) This section applies to an application for listing or registration of a
therapeutic good under section 23 if:
(a) the therapeutic good is, or contains, a GM product or a
genetically modified organism; and
(b) if the application is for registration—the application has
passed preliminary assessment; and
(c) if the application is for the listing of a medicine under
section 26AE—the application has passed preliminary
assessment.
(2) Subject to subsection (5), the Secretary must give written notice to
the Gene Technology Regulator:
(a) stating that the application has been made; and
(b) requesting the Gene Technology Regulator to give advice
about the application.
(3) If the Secretary gives the Gene Technology Regulator a notice
under subsection (2), the Gene Technology Regulator may give
written advice to the Secretary about the application.
(4) The advice is to be given within the period specified in the notice.
(5) If an advice from the Gene Technology Regulator is in force under
section 30D in relation to a class of therapeutic goods, the
Secretary is not required to notify the Regulator under this section
in relation to an application for listing or registration of a
therapeutic good belonging to that class.
30D Secretary may seek advice about classes of GM products or
genetically modified organisms
(1) The Secretary may request advice from the Gene Technology
Regulator in relation to:
(a) therapeutic goods that consist of, or that contain, a GM
product belonging to a class of GM products specified in the
request; or
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(b) therapeutic goods that consist of, or that contain, a
genetically modified organism belonging to a class of
genetically modified organisms specified in the request.
(2) A request for advice under subsection (1) must specify the matters
to which the advice is to relate.
(3) If the Secretary requests advice from the Gene Technology
Regulator under subsection (1), the Gene Technology Regulator
may provide written advice in relation to the matters specified in
the request.
(4) If the Gene Technology Regulator gives advice to the Secretary
under subsection (3), the advice remains in force until it is
withdrawn by the Gene Technology Regulator by written notice
given to the Secretary.
30E Secretary to take advice into account
If the Secretary receives advice from the Gene Technology
Regulator:
(a) in response to a notice under section 30C within the period
specified in the notice; or
(b) under section 30D;
the Secretary must:
(c) ensure that the advice is taken into account in making a
decision on the application to which the notice relates, or on
an application to which the advice under section 30D relates,
as the case requires; and
(d) inform the Gene Technology Regulator of the decision on the
application.
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Division 2A Public notification, and recall, of therapeutic goods
Section 30EA
Division 2A—Public notification, and recall, of therapeutic
goods
30EA Public notification, and recall, of therapeutic goods
(1) The Secretary may, in writing, impose requirements, relating to
therapeutic goods, on a person if:
(a) any of the circumstances referred to in the second column of
an item in the following table occur in relation to the goods;
and
(b) the person is referred to in the third column of that item.
Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
1. The goods are supplied while they are
registered goods or listed goods, but the
Secretary is satisfied that they do not conform
with a standard applicable to the goods
The person in relation to
whom the goods are
included in the Register
2. The goods are supplied while they are
registered goods or listed goods, but the
Secretary is satisfied that the manufacturing
principles have not been observed in the
manufacture of the goods
The person in relation to
whom the goods are
included in the Register
3. The goods are supplied while:
(a) they are exempt goods; or
(b) they are exempt under section 18A; or
(c) they are the subject of an approval or
authority under section 19; or
(d) they are the subject of an approval under
section 19A;
but the Secretary is satisfied that they do not
conform with a standard applicable to the goods
The person supplying the
goods
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Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
4. The goods are supplied while: The person supplying the
(a) they are exempt goods; or goods
(b) they are exempt under section 18A; or
(c) they are the subject of an approval or
authority under section 19; or
(d) they are the subject of an approval under
section 19A;
but the Secretary is satisfied that the
manufacturing principles have not been
observed in the manufacture of the goods
5. The goods are supplied in contravention of The person supplying the
subsection 19B(1), (4) or (4A) or 19D(1) goods
5A. The goods are supplied while they are
registered goods or listed goods, but it appears
to the Secretary that:
(a) the quality, safety or efficacy of the goods is
unacceptable; or
(b) in the case of registered goods—the
presentation of the goods is not acceptable;
or
(c) in the case of listed goods—the presentation
of the goods is unacceptable
The person in relation to
whom the goods are
included in the Register
6. The goods are supplied while they are
registered goods or listed goods, but one or
more steps in the manufacture of the goods has
been carried out by a manufacturer while the
manufacturer did not hold a licence that was in
force
The person in relation to
whom the goods are
included in the Register
6A. The registration or listing of the goods has been
suspended under this Part
The person in relation to
whom the goods were
included in the Register
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Circumstances in which requirements may be imposed
Item Circumstance relating to therapeutic goods Person subject to
requirements
7. The registration or listing of the goods has been The person in relation to
cancelled under this Part whom the goods were
included in the Register
8. The goods are counterfeit (within the meaning The person supplying the
of section 42E) goods
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall therapeutic
goods that have been distributed;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, to the effect that the circumstances referred to in
paragraph (1)(a) have occurred in relation to therapeutic
goods;
(ba) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, of specified information, or of information of a
specified kind, relating to either or both of the following:
(i) therapeutic goods;
(ii) the circumstances referred to in paragraph (1)(a) in
relation to therapeutic goods;
(c) to publish, in the specified manner and within such
reasonable period as is specified, specified information, or
information of a specified kind, relating to the manufacture
or distribution of therapeutic goods;
(d) to notify the Secretary, in the specified manner and within
such reasonable period as is specified, of specified
information, or of information of a specified kind, relating to
the persons to whom therapeutic goods have been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to a
batch of therapeutic goods, the Secretary may limit the imposition
of the requirements to the therapeutic goods included in that batch.
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Section 30EB
(4) A requirement to recall therapeutic goods under this section does
not apply to therapeutic goods that cannot be recalled because they
have been administered to, or applied in the treatment of, a person.
30EB Publication of requirements
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing a
requirement under section 30EA, a notice setting out particulars of
the requirement.
30EC Criminal offences for non-compliance with requirements
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
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Section 30ECA
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
30ECA Civil penalty for non-compliance with requirements
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 30EA.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
30ED Powers of suspension and cancellation unaffected
Imposition of a requirement under section 30EA does not affect the
Secretary’s power to suspend or cancel the registration or listing of
therapeutic goods under this Part.
30EE Saving of other laws
This Division is not intended to exclude or limit the operation of
any other law of the Commonwealth or any law of a State or
Territory.
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Reporting medicine shortages and discontinuation of supply of medicine Division 2B
Section 30EF
Division 2B—Reporting medicine shortages and
discontinuation of supply of medicine
30EF Reporting medicine shortages
(1) A person in relation to whom a reportable medicine is included in
the Register must notify the Secretary of any shortage of the
medicine in Australia. The person must do so:
(a) for a shortage that has a critical impact—as soon as possible,
but no later than 2 working days, after the first day the person
knows, or ought reasonably to have known, of the shortage;
or
(b) in any other case—before the end of 10 working days
beginning on the first day the person knows, or ought
reasonably to have known, of the shortage.
Note: For reportable medicine, see section 30EH. For shortage of a
medicine in Australia, see section 30EI.
Critical impact
(2) The shortage of a medicine in Australia at a particular time has a
critical impact if, at that time, the medicine is included in an
instrument under section 30EJ.
(3) The shortage of a medicine in Australia at a particular time also has
a critical impact if:
(a) either:
(i) at that time, there are no registered goods that could
reasonably be used as a substitute for the medicine; or
(ii) at that time, there are other registered goods that could
reasonably be used as a substitute for the medicine but
the other registered goods are not likely to be available
in sufficient quantities to meet the demand for the other
registered goods that is likely to arise because of the
shortage; and
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Section 30EF
(b) the shortage has the potential to have a life-threatening
impact on, or a serious impact on the physical or mental
health or functioning of, persons who take, or who may need
to take, the medicine.
Notification requirements
(4) A notification under subsection (1) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain the information required by that form.
(5) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Civil penalty
(6) A person contravenes this subsection if:
(a) the person is subject to a requirement under subsection (1);
and
(b) the person contravenes the requirement.
Maximum civil penalty:
(a) for an individual—100 penalty units; and
(b) for a body corporate—1,000 penalty units.
Exception
(7) Subsection (6) does not apply if:
(a) paragraph (1)(a) and subsection (3) apply in relation to the
shortage but subsection (2) does not; and
(b) as a result of steps taken by the person, it was reasonable for
the person to assume that paragraph (1)(b) applied in relation
to the shortage; and
(c) the person complied with paragraph (1)(b) in relation to the
shortage.
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Section 30EG
30EG Reporting discontinuation of supply of medicine
(1) A person in relation to whom a reportable medicine is included in
the Register must notify the Secretary of any decision (the
discontinuation decision) of the person to permanently discontinue
the supply of the medicine in Australia. The person must do so:
(a) if the discontinuation is likely to be of critical impact:
(i) at least 12 months before the discontinuation is
proposed to occur; or
(ii) if the person is unable to comply with
subparagraph (i)—as soon as practicable after the
decision is made; or
(b) in any other case:
(i) at least 6 months before the discontinuation is proposed
to occur; or
(ii) if the person is unable to comply with
subparagraph (i)—as soon as practicable after the
decision is made.
Note: For reportable medicine, see section 30EH.
Critical impact
(2) The discontinuation of the supply of a medicine in Australia is
likely to be of critical impact if, when the discontinuation decision
is made, the medicine is included in an instrument under
section 30EJ.
(3) The discontinuation of the supply of a medicine in Australia is also
likely to be of critical impact if:
(a) either:
(i) when the discontinuation decision is made, there are no
registered goods that could reasonably be used as a
substitute for the medicine; or
(ii) when the discontinuation decision is made, there are
other registered goods that could reasonably be used as
a substitute for the medicine but the other registered
goods are not likely to be available in sufficient
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Section 30EG
quantities to meet the demand for the other registered
goods that is likely to arise because of the
discontinuation; and
(b) the discontinuation has the potential to have a life-threatening
impact on, or a serious impact on the physical or mental
health or functioning of, persons who take, or who may need
to take, the medicine.
Notification requirements
(4) A notification under subsection (1) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain the information required by that form.
(5) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Civil penalty
(6) A person contravenes this subsection if:
(a) the person is subject to a requirement under subsection (1);
and
(b) the person contravenes the requirement.
Maximum civil penalty:
(a) for an individual—100 penalty units; and
(b) for a body corporate—1,000 penalty units.
Exception
(7) Subsection (6) does not apply if:
(a) paragraph (1)(a) and subsection (3) apply in relation to the
discontinuation but subsection (2) does not; and
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(b) as a result of steps taken by the person, it was reasonable for
the person to assume that paragraph (1)(b) applied in relation
to the discontinuation; and
(c) the person complied with paragraph (1)(b) in relation to the
discontinuation.
30EH What is a reportable medicine?
(1) For the purposes of this Act, registered goods are a reportable
medicine if:
(a) the goods are medicine; and
(b) either:
(i) the medicine contains one or more substances included
in Schedule 4 or 8 to the current Poisons Standard; or
(ii) the medicine is determined in an instrument under
subsection (2).
(2) The Minister may, by legislative instrument, determine medicine
for the purposes of subparagraph (1)(b)(ii).
(3) The Minister must not determine a medicine unless the Minister is
satisfied of either or both of the following:
(a) the medicine is critical to the health of patients in Australia;
(b) the notification to the Secretary of any shortage of the
medicine, or of any decision to permanently discontinue the
supply of the medicine, in Australia would be in the interests
of public health.
30EI When is there a medicine shortage?
For the purposes of this Act, there is a shortage of a medicine in
Australia at a particular time if, at any time in the 6 months after
that particular time, the supply of that medicine in Australia will
not, or will not be likely to, meet the demand for the medicine for
all of the patients in Australia who take, or who may need to take,
the medicine.
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Section 30EJ
30EJ Medicines Watch List
(1) The Minister may, by legislative instrument, determine medicine
for the purposes of subsections 30EF(2) and 30EG(2).
(2) The Minister must not determine a medicine unless the Minister is
satisfied that any shortage of the medicine, or any permanent
discontinuation of the supply of the medicine, in Australia has the
potential to result in:
(a) significant morbidity in patients in Australia; or
(b) the death of one or more patients in Australia.
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Division 3—General
30F Criminal offences for goods exempt under section 18A not
conforming to standards etc.
(1) This section applies if:
(a) therapeutic goods of a particular kind are exempt under
section 18A; and
(b) a person supplies a batch of goods of that kind; and
(c) the Secretary is satisfied that the goods included in that
batch:
(i) do not conform to a standard applicable to goods of that
kind; or
(ii) are otherwise not fit to be used for their intended
purposes.
(2) The Secretary may, by written notice given to the person, require
the person to take steps to recall the goods included in that batch
(except any of those goods that cannot be recalled because they
have been administered to, or applied in the treatment of, a person).
(3) The notice may specify one or more of the following requirements:
(a) the steps to be taken to recall the goods;
(b) the manner in which the steps are to be taken;
(c) a reasonable period within which the steps are to be taken.
(4) The Secretary must, as soon as practicable after giving the notice,
cause particulars of it to be published in the Gazette or on the
Department’s website.
Written notice is not a legislative instrument
(4A) A written notice given to a person by the Secretary under this
section is not a legislative instrument.
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Offences
(4B) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
failed to comply with that requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
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(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: 100 penalty units.
(6A) An offence against subsection (6) is an offence of strict liability.
Saving of other laws
(7) This section is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
30FA Civil penalty for goods exempt under section 18A not
conforming to standards etc.
A person contravenes this section if:
(a) the Secretary gives a notice to the person under
subsection 30F(2); and
(b) the notice specifies a particular requirement mentioned in
subsection 30F(3); and
(c) the person does not comply with the requirement.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
30G Disposal of unused goods exempt under section 18A
(1) This section applies to particular therapeutic goods if:
(a) an exemption in relation to those goods under section 18A
ceases to have effect otherwise than because those goods
have become registered goods or listed goods (see
paragraph 18A(5)(a)); and
(b) those goods have not been used before the exemption so
ceases to have effect.
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(2) The Secretary may arrange for the disposal of any of those goods
in accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out
the methods by which those goods are to be stored, supplied,
destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not
enable or permit any benefit to be conferred on a person (including
the Commonwealth) other than the owner of those goods.
30H Record for goods exempt under section 18A
(1) A person commits an offence if:
(a) there are therapeutic goods that are exempt under
section 18A; and
(b) a condition of the exemption:
(i) requires the person to keep a record about those goods;
or
(ii) specifies the manner in which the person must keep the
record; and
(c) the person does an act or omits to do an act in relation to
those goods; and
(d) the act or omission results in the breach of that condition of
the exemption.
Penalty: 240 penalty units.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) A person commits an offence if:
(a) there are therapeutic goods that are exempt under
section 18A; and
(b) a condition of the exemption:
(i) requires the person to keep a record about those goods;
or
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(ii) specifies the manner in which the person must keep the
record; and
(c) the person does an act or omits to do an act in relation to
those goods; and
(d) the act or omission results in the breach of that condition of
the exemption.
Penalty: 60 penalty units.
(4) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
31 Secretary may require information or documents
(1) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the registration of therapeutic goods;
or
(ab) in relation to whom therapeutic goods are registered; or
(ac) in relation to whom therapeutic goods were, at any time
during the previous 5 years, registered;
require the person to give to the Secretary, within such reasonable
time as is specified in the notice and in such form as is specified in
the notice, information or documents relating to one or more of the
following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of the
goods and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the goods;
(f) the presentation of the goods;
(g) the safety and efficacy of the goods for the purposes for
which they are to be used;
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(ga) whether the goods comply with conditions (if any) on the
registration of the goods;
(gb) the conformity of the goods to a standard applicable to the
goods;
(h) whether either of the following has not been complied with in
relation to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations;
(ha) if the goods are registered in relation to the person—whether
the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(j) the regulatory history of the goods in another country;
(ja) if the goods are a reportable medicine and the medicine is
registered in relation to the person:
(i) whether or not there is a shortage of the medicine in
Australia; or
(ii) if there is a shortage of the medicine in Australia—the
shortage; or
(iii) any decision of the person to permanently discontinue
the supply of the medicine in Australia;
(k) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
(1A) If a notice is given under subsection (1) to a person covered by
paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the therapeutic
goods were registered.
(1B) If:
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(a) a person makes an application under section 23 for the
registration of therapeutic goods in accordance with a form
referred to in paragraph 23B(2)(a); and
(aa) the application has passed preliminary assessment; and
(b) the form is described as a pre-submission planning form; and
(c) the person chooses a number of days specified in the form for
the purposes of giving information or documents to the
Secretary in the event that the person is given a notice under
subsection (1) of this section in relation to the application;
then that number of days must be specified in any such notice as
the time within which the person must give the required
information or documents to the Secretary. The number of days so
specified is taken to be a reasonable time for the purposes of
subsection (1).
(1C) If:
(a) the person in relation to whom therapeutic goods are
registered makes a request under subsection 9D(3) in
accordance with a form referred to in subsection 9D(6); and
(b) the form is described as a pre-submission planning form; and
(c) the person chooses a number of days specified in the form for
the purposes of giving information or documents to the
Secretary in the event that the person is given a notice under
subsection (1) of this section in relation to the request;
then that number of days must be specified in any such notice as
the time within which the person must give the required
information or documents to the Secretary. The number of days so
specified is taken to be a reasonable time for the purposes of
subsection (1).
(2) The Secretary may, by notice in writing given to a person:
(aa) who is an applicant for the listing of therapeutic goods; or
(ab) in relation to whom therapeutic goods are listed; or
(ac) in relation to whom therapeutic goods were, at any time
during the previous 5 years, listed;
require the person to give to the Secretary, within such reasonable
time as is specified in the notice and in such form as is specified in
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the notice, information or documents relating to one or more of the
following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(ca) the quality of the goods;
(d) the method and place of manufacture or preparation of the
goods and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the goods;
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they are to
be used;
(fa) if the goods are listed under section 26A—any of the matters
covered by a certification by the person under
subsection 26A(2) or (2A) in relation to the medicine;
(fab) if the goods are or were listed under section 26AE—any of
the matters covered by a certification by the person under
subsection 26AB(2) or (3) in relation to the medicine;
(fac) if the goods are or were listed under section 26AE—the
efficacy of the goods in relation to the purposes for which
they are to be used;
(fb) whether the goods comply with conditions (if any) on the
listing of the goods;
(g) the conformity of the goods to a standard applicable to the
goods;
(gaa) whether either of the following has not been complied with in
relation to the goods:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or the regulations;
(ga) if the goods are listed in relation to the person—whether the
goods are being:
(i) supplied in Australia; or
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(ii) imported into Australia; or
(iii) exported from Australia;
(h) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
(2A) If a notice is given under subsection (2) to a person covered by
paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the therapeutic
goods were listed.
(3) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the
person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the
person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
(4A) Subsection (4) does not apply if the person has a reasonable
excuse.
Note: The defendant bears an evidential burden in relation to the matter in
subsection (4A). See subsection 13.3(3) of the Criminal Code.
(4B) A person commits an offence if:
(a) either:
(i) the person is given a notice under subsection (1) and the
person is covered by paragraph (1)(ab) or (ac); or
(ii) the person is given a notice under subsection (2) and the
person is covered by paragraph (2)(ab) or (ac); and
(b) the person fails to comply with the notice.
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Penalty: 100 penalty units.
(5) An offence against subsection (4B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5AA) Subsection (4B) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (5AA): see subsection 13.3(3) of the Criminal Code.
(5A) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular; and
(d) either:
(i) the use of the therapeutic goods has resulted in, will
result in, or is likely to result in, harm or injury to any
person; or
(ii) the use of the therapeutic goods, if the therapeutic goods
were used, would result in, or would be likely to result
in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (6) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(6) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
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(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(7) A person commits an offence if:
(a) the person is given a notice under this section in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(8) An offence against subsection (7) is an offence of strict liability.
31AAA Civil penalty for providing false or misleading information
or documents in relation to therapeutic goods
A person contravenes this section if:
(a) the person is given a notice under section 31 in relation to
therapeutic goods; and
(b) the person gives information or a document in compliance or
purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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31A Secretary may require information etc. about goods exempt
under section 18
Exempt goods for use for experimental purposes in humans
(1) If therapeutic goods are exempt under subsection 18(1) from the
operation of this Part (except this section and sections 31C to 31F)
to allow for their use for experimental purposes in humans, the
Secretary may give the sponsor of the goods a written notice
requiring the sponsor to give to the Secretary specified information
or documents relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Statement by medical practitioner about medicine
(2) If a medicine is exempt under subsection 18(1) from the operation
of this Part (except this section and sections 31C to 31F) because a
medical practitioner has signed a statement in accordance with
regulation 12A of the Therapeutic Goods Regulations 1990, the
Secretary may give the medical practitioner a written notice
requiring the medical practitioner to give to the Secretary specified
information or documents relating to one or more of the following:
(a) the condition of the person to whom the medicine is to be
given or is given;
(b) the supply of the medicine;
(c) the handling of the medicine;
(d) the monitoring of the supply of the medicine;
(e) the results of the supply of the medicine;
(f) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to medicines of that
kind.
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Compliance period
(3) A notice under subsection (1) or (2) must specify a reasonable
period within which the person to whom the notice is given must
comply with it. The period must be at least 14 days starting on the
day on which the notice is given.
Information may need to be given in accordance with specified
software requirements
(4) A notice under subsection (1) or (2) may require information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31AA Secretary may require information etc. about goods exempt
under section 18A
(1) This section applies to a person who is required to comply with a
condition of an exemption of therapeutic goods under section 18A.
(2) The Secretary may, by written notice given to the person, require
the person to give to the Secretary specified information or
documents relating to one or more of the following:
(a) the supply of any of those goods;
(b) the handling of any of those goods;
(c) the monitoring of the supply of any of those goods;
(d) the results of the supply of any of those goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph.
Compliance period
(3) The notice must specify a reasonable period within which the
person must comply with it. The period must be at least 14 days
starting on the day on which the notice is given.
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Information may need to be given in accordance with specified
software requirements
(4) The notice may require information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31B Secretary may require information relating to approvals and
authorities under section 19
Approval under subsection 19(1)
(1) The Secretary may give to a person who is granted an approval
under subsection 19(1) in relation to specified therapeutic goods a
written notice requiring the person to give to the Secretary
specified information or documents relating to one or more of the
following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Approval under subsection 19(1)—use by another person
(2) The Secretary may give to a person using specified therapeutic
goods that are the subject of an approval granted to someone else
under paragraph 19(1)(b) a written notice requiring the person to
give to the Secretary specified information or documents relating
to either of both of the following:
(a) the use of the goods;
(b) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
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Authority under subsection 19(5)
(3) The Secretary may give to a person who is granted an authority
under subsection 19(5) in relation to specified therapeutic goods, or
a specified class of therapeutic goods, a written notice requiring the
person to give to the Secretary specified information or documents
relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Authority under subsection 19(7A) rules
(3A) If a person is authorised, by subsection 19(7A) rules, to supply
therapeutic goods, the Secretary may give the person a written
notice requiring the person to give the Secretary specified
information or documents relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to goods of that kind.
Compliance period
(4) A notice under subsection (1), (2), (3) or (3A) must specify a
reasonable period within which the person to whom the notice is
given must comply with it. The period must be at least 14 days
starting on the day on which the notice is given.
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Information may need to be given in accordance with specified
software requirements
(5) A notice under subsection (1), (2), (3) or (3A) may require
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
31BA Secretary may require information about therapeutic goods
approved under section 19A
(1) The Secretary may give to a person who is granted an approval
under subsection 19A(1), (1A) or (2) in relation to specified
therapeutic goods a written notice requiring the person to give to
the Secretary specified information, or to produce to the Secretary
specified documents, relating to one or more of the following:
(a) the supply of the goods;
(b) the handling of the goods;
(c) the monitoring of the supply of the goods;
(d) the results of the supply of the goods;
(e) any other matter prescribed by the regulations.
Compliance
(2) A person given a notice under subsection (1) must give the
information, or produce the documents, to the Secretary:
(a) within the period specified in the notice (which must not be
less than 14 days after the day the notice is given); and
(b) in the form specified in the notice.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
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General Division 3
Section 31C
31C Criminal offences for failing to give information or documents
sought under section 31A, 31AA, 31B or 31BA
(1) A person commits an offence if:
(a) the person is given a notice under section 31A, 31AA, 31B or
31BA; and
(b) the person fails to comply with the notice.
Penalty: 400 penalty units.
(2) A person commits an offence if:
(a) the person is given a notice under section 31A, 31AA, 31B or
31BA; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(3) An offence against subsection (2) is an offence of strict liability.
31D False or misleading information
(1) A person to whom a notice is given under section 31A, 31AA, 31B
or 31BA commits an offence if:
(a) the person gives information to the Secretary in compliance
or purported compliance with the notice; and
(b) the person does so knowing that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(1A) A person to whom a notice is given under section 31A, 31AA, 31B
or 31BA commits an offence if:
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Section 31E
(a) the person gives information to the Secretary in compliance
or purported compliance with the notice; and
(b) the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) Subsection (1) or (1A) does not apply as a result of
subparagraph (1)(b)(i) or (1A)(b)(i) if the information is not false
or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2): see subsection 13.3(3) of the Criminal Code.
(3) Subsection (1) or (1A) does not apply as a result of
subparagraph (1)(b)(ii) or (1A)(b)(ii) if the information did not
omit any matter or thing without which the information is
misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3): see subsection 13.3(3) of the Criminal Code.
31E False or misleading documents
(1) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the person does so knowing that the document is false or
misleading; and
(c) the document is produced in compliance or purported
compliance with a notice given under section 31A, 31AA,
31B or 31BA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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Section 31F
(1A) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the document is false or misleading; and
(c) the document is produced in compliance or purported
compliance with a notice given under section 31A, 31AA,
31B or 31BA.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) Subsection (1) or (1A) does not apply if the document is not false
or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2): see subsection 13.3(3) of the Criminal Code.
(3) Subsection (1) or (1A) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3): see subsection 13.3(3) of the Criminal Code.
31F Self-incrimination
(1) A person is not excused from giving information or a document
under a notice given under section 31, 31A, 31AA, 31B or 31BA
on the ground that the giving of the information or document
would tend to incriminate the person or expose the person to a
penalty.
(2) However, in the case of an individual:
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Section 31F
(a) the information given; or
(b) the giving of the document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, subsection 31(5A), (6)
or (7) or section 31D or 31E; or
(e) civil proceedings, except proceedings under section 42Y for
a contravention of section 31AAA.
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Biologicals Part 3-2A
Preliminary Division 1
Section 32
Part 3-2A—Biologicals
Division 1—Preliminary
32 What this Part is about
This Part regulates biologicals. It does this by providing a process
for including biologicals in the Register and providing for
enforcement through criminal offences and civil penalties.
This Part provides for the following administrative processes:
(a) exempting biologicals from the requirement to be
included in the Register;
(b) making the inclusion of biologicals in the Register
subject to conditions;
(c) suspending or cancelling entries of biologicals
from the Register;
(d) requiring public notification of problems with
biologicals, and recall of biologicals;
(e) obtaining information or documents about
biologicals.
32A Meaning of biological
(1) Subject to subsection (3), a biological is a thing that:
(a) either:
(i) comprises, contains or is derived from human cells or
human tissues; or
(ii) is specified under subsection (2); and
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Section 32AA
(b) is represented in any way to be, or is, whether because of the
way in which it is presented or for any other reason, likely to
be taken to be:
(i) for use in the treatment or prevention of a disease,
ailment, defect or injury affecting persons; or
(ii) for use in making a medical diagnosis of the condition
of a person; or
(iii) for use in influencing, inhibiting or modifying a
physiological process in persons; or
(iv) for use in testing the susceptibility of persons to a
disease or ailment; or
(v) for use in the replacement or modification of parts of the
anatomy in persons.
(2) The Secretary may, by legislative instrument, specify things for the
purposes of subparagraph (1)(a)(ii).
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) The Secretary may, by legislative instrument, determine that a
specified thing is not a biological for the purposes of this Act.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
32AA Biological classes
The regulations may prescribe different classes of biologicals.
Note 1: The regulations may prescribe the circumstances in which a biological
included in a class of biologicals is separate and distinct from other
biologicals: see section 32AB.
Note 2: The Secretary may approve different application forms for different
classes of biologicals: see section 32DDA.
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Preliminary Division 1
Section 32AB
32AB When biologicals are separate and distinct from other
biologicals
(1) The regulations may prescribe the circumstances in which a
biological included in a specified class of biologicals is separate
and distinct from other biologicals.
(2) The regulations may make different provision in relation to
different classes of biologicals that are prescribed by the
regulations for the purposes of section 32AA.
Note: The Secretary may cancel the entry of a biological from the Register if
the biological has changed so that it has become separate and distinct
from the biological as so included: see subsection 32GC(1).
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Section 32B
Division 2—Main criminal offences and civil penalties
32B What this Division is about
This Division contains criminal offences and civil penalties
relating to the import, export, manufacture, supply and use of
biologicals.
32BA Criminal offences for importing a biological
(1) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 32BA
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
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(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the importation.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
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Section 32BB
32BB Criminal offences for exporting a biological
(1) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
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(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the exportation.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
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Section 32BBA
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BBA Treating biologicals as prohibited imports or exports
If:
(a) the importation or exportation of a biological is an offence
under subsection 32BA(1), (4) or (4A) or 32BB(1), (4) or
(4A); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the biological included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
32BC Criminal offences for manufacturing a biological
(1) A person commits an offence if:
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(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Section 32BC
(4A) A person commits an offence if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the manufacture.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological.
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Section 32BD
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BD Criminal offences for supplying a biological
(1) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological; and
(c) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
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Section 32BD
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(4A) A person commits an offence if:
(a) the person supplies in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
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Section 32BD
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
Defences
(5) Subsection (1), (4) or (4A) does not apply if the defendant proves
that the defendant was not the sponsor of the biological at the time
of the supply.
Note: A defendant bears a legal burden in relation to the matter in
subsection (5): see section 13.4 of the Criminal Code.
(6) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
(iii) the improper use of the biological; or
(b) harm or injury would not, or would not be likely to, directly
result from:
(i) the quality, safety or efficacy of the biological; or
(ii) a matter relating to the labelling or packaging of the
biological; or
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Section 32BE
(iii) the improper use of the biological.
Note: A defendant bears an evidential burden in relation to the matters in
subsection (6): see subsection 13.3(3) of the Criminal Code.
32BE Notice required to adduce evidence in support of exception to
offences
(1) If:
(a) a defendant is committed for trial for an offence against
subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or
(b) an offence against subsection 32BA(1), 32BB(1), 32BC(1) or
32BD(1) is to be heard and determined by a court of
summary jurisdiction;
the committing magistrate or the court must:
(c) inform the defendant of the requirements of this section; and
(d) cause a copy of this section to be given to the defendant.
(2) A defendant must not, without leave of the court, adduce evidence
in support of the exception under subsection 32BA(6), 32BB(6),
32BC(6) or 32BD(6) unless the defendant gives notice of
particulars of the exception:
(a) if paragraph (1)(a) applies—more than 21 days before the
trial begins; or
(b) if paragraph (1)(b) applies—more than 21 days before the
hearing of the offence begins.
(3) A defendant must not, without leave of the court, call any other
person to give evidence in support of the exception unless:
(a) the notice under subsection (2) includes the name and
address of the person or, if the name and address is not
known to the defendant at the time the defendant gives the
notice, any information in the defendant’s possession that
might be of material assistance in finding the person; and
(b) if the name or the address is not included in the notice—the
court is satisfied that the defendant before giving the notice
took, and after giving the notice continued to take, all
reasonable steps to ascertain the name or address; and
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(c) if the name or address is not included in the notice, but the
defendant subsequently ascertains the name or address or
receives information that might be of material assistance in
finding the person—the defendant immediately gives notice
of the name, address or other information, as the case may
be; and
(d) if the defendant is told by or on behalf of the prosecutor that
the person has not been found by the name, or at the address,
given by the defendant:
(i) the defendant immediately gives notice of any
information in the defendant’s possession that might be
of material assistance in finding the person; and
(ii) if the defendant later receives any such information—
the defendant immediately gives notice of the
information.
(4) A notice purporting to be given under this section on behalf of the
defendant by the defendant’s legal practitioner is, unless the
contrary is proved, taken as having been given with the authority of
the defendant.
(5) Any evidence tendered to disprove that the exception applies may,
subject to direction by the court, be given before or after evidence
is given in support of the exception.
(6) A notice under this section must be given in writing to the Director
of Public Prosecutions. A notice is taken as having been given if it
is:
(a) delivered to or left at an office of the Office of the Director of
Public Prosecutions; or
(b) sent by certified mail addressed to the Director of Public
Prosecutions at an office of the Office of the Director of
Public Prosecutions.
(7) In this section:
Director of Public Prosecutions means a person holding office as,
or acting as, the Director of Public Prosecutions under the Director
of Public Prosecutions Act 1983.
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Section 32BF
32BF Civil penalties for importing, exporting, manufacturing or
supplying a biological
Importing a biological for use in humans
(1) A person contravenes this subsection if:
(a) the person imports into Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the importation into Australia of the
biological;
(v) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exporting a biological for use in humans
(2) A person contravenes this subsection if:
(a) the person exports from Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
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(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the exportation from Australia of the
biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Manufacturing a biological for use in humans
(3) A person contravenes this subsection if:
(a) the person manufactures in Australia a biological for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Supplying a biological for use in humans
(4) A person contravenes this subsection if:
(a) the person supplies in Australia a biological for use in
humans; and
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(b) none of the following subparagraphs applies:
(i) the biological is included in the Register in relation to
the person;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Exception if person was not the sponsor of the biological
(5) Subsection (1), (2), (3) or (4) does not apply if the person proves
that he or she was not the sponsor of the biological at the time of
the importation, exportation, manufacture or supply, as the case
may be.
Civil penalty relating to the supply of biologicals included in the
Register
(6) A person contravenes this subsection if:
(a) a biological is included in the Register in relation to the
person; and
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Section 32BG
(b) the biological is of a kind prescribed by the regulations for
the purposes of this paragraph; and
(c) the person supplies the biological in Australia; and
(d) the biological number of the biological is not set out on the
label of the biological in the prescribed manner.
Maximum civil penalty:
(a) for an individual—200 penalty units; and
(b) for a body corporate—2,000 penalty units.
Application of the Customs Act 1901
(7) If:
(a) the importation or exportation of a biological contravenes
subsection (1) or (2); and
(b) the Secretary notifies the Comptroller-General of Customs in
writing that the Secretary wishes the Customs Act 1901 to
apply to that importation or exportation;
the Customs Act 1901 has effect as if the biological included in that
importation or exportation were goods described as forfeited to the
Crown under section 229 of that Act because they were:
(c) prohibited imports within the meaning of that Act; or
(d) prohibited exports within the meaning of that Act;
as the case requires.
32BG Criminal offences and civil penalty relating to a failure to
notify the Secretary about manufacturing
Criminal offences
(1) A person commits an offence if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
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(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(1A) A person commits an offence if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
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Division 2 Main criminal offences and civil penalties
Section 32BG
Civil penalty
(2) A person contravenes this subsection if:
(a) the person:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans;
or
(iii) manufactures a biological in Australia for use in
humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in
relation to the biological and the biological is not exempt
under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation,
exportation, manufacture or supply, properly notified to the
Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Definition
(3) For the purposes of this section:
(a) a manufacturer is properly notified to the Secretary if:
(i) the manufacturer was nominated, as a manufacturer of
the biological, in an application for inclusion of the
biological in the Register; or
(ii) the Secretary was subsequently informed in writing that
the manufacturer is a manufacturer of the biological;
and
(b) premises are properly notified to the Secretary if:
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Section 32BH
(i) the premises were nominated, as premises used in the
manufacture of the biological, in an application for
inclusion of the biological in the Register; or
(ii) the Secretary was subsequently informed in writing that
the premises are used in the manufacture of the
biological.
32BH Criminal offence relating to wholesale supply
A person commits an offence if:
(a) the person supplies a biological in Australia for use in
humans; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person, being an
approval covering the supply in Australia of the
biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person, being an approval covering the supply in
Australia of the biological; and
(c) the person to whom the biological is supplied is not the
ultimate consumer of the biological.
Penalty: 120 penalty units.
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Part 3-2A Biologicals
Division 2 Main criminal offences and civil penalties
Section 32BI
32BI Criminal offence for using a biological not included in the
Register
(1) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A); and
(d) either:
(i) if the person used the biological in the treatment of that
other person—the use of the biological has resulted in,
will result in, or is likely to result in, harm or injury to
that other person; or
(ii) if the person used the biological solely for experimental
purposes in humans—the use of the biological has
resulted in, will result in, or is likely to result in, harm
or injury to any of those humans.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 32BI
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A).
Penalty: 500 penalty units.
(5) A person commits an offence if:
(a) the person uses a biological; and
(b) the biological is used:
(i) in the treatment of another person; or
(ii) solely for experimental purposes in humans; and
(c) none of the following subparagraphs applies:
(i) the biological is included in the Register;
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Section 32BJ
(ii) the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt
under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2);
(v) the person uses the biological in accordance with an
approval under subsection 32CK(1);
(vi) the person uses the biological in accordance with a
condition applicable under regulations made for the
purposes of section 32CL;
(vii) the person uses the biological in accordance with an
authority under subsection 32CM(1) or (7A).
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32BJ General criminal offences relating to this Part
Including incorrect biological number on containers etc.
(1) A person commits an offence if:
(a) the person sets out or causes to be set out, on a container or
package that contains a biological or on a label of a
biological, a number that purports to be the biological
number of the biological; and
(b) the number is not that biological number.
Penalty: 60 penalty units.
(2) For the purposes of subsection (1), number includes any
combination of one or more of the following:
(a) numbers;
(b) letters;
(c) symbols.
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Section 32BJ
Advertising biological for an indication
(2A) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion; and
(d) either:
(i) the use of the biological for the advertised indication
has resulted in, will result in, or is likely to result in,
harm or injury to any person; or
(ii) the use of the biological for the advertised indication, if
the biological were so used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2B) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(3) A person commits an offence if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Penalty: 100 penalty units.
(3A) An offence against subsection (3) is an offence of strict liability.
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Division 2 Main criminal offences and civil penalties
Section 32BK
Arranging supply of biological not included in Register
(4) A person commits an offence if:
(a) the person claims, by any means, that the person or another
person can arrange the supply of a biological; and
(b) none of the following subparagraphs applies:
(i) the biological is included in the Register;
(ii) the person or other person is exempt under
subsection 32CA(1) in relation to the biological or the
biological is exempt under subsection 32CA(2);
(iii) the biological is exempt under section 32CB;
(iv) the biological is the subject of an approval under
subsection 32CK(1) that is held by the person or other
person, being an approval covering the supply in
Australia of the biological;
(v) the biological is the subject of an authority under
subsection 32CM(1) or (7A) that covers the supply of
the biological by the person or other person;
(vi) the biological is the subject of an approval under
subsection 32CO(1), (1A) or (2) that is held by the
person or other person, being an approval covering the
supply in Australia of the biological.
Penalty for contravention of this subsection:60 penalty units.
32BK Civil penalty for making misrepresentations about biologicals
(1) A person contravenes this section if:
(a) the person makes a representation of a kind referred to in
subsection (2); and
(b) the representation is false or misleading.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) Subsection (1) applies to the following representations:
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Section 32BL
(a) representations that a biological is included in the Register;
(b) representations that a person is exempt under
subsection 32CA(1) in relation to a biological or that a
biological is exempt under subsection 32CA(2);
(c) representations that a biological is exempt under
section 32CB;
(d) representations that a biological is the subject of an approval
under subsection 32CK(1);
(e) representations that a biological is the subject of an authority
under subsection 32CM(1) or (7A);
(f) representations that a biological is the subject of an approval
under subsection 32CO(1), (1A) or (2).
32BL Civil penalty for advertising biological for an indication
A person contravenes this section if:
(a) the person, by any means, advertises a biological for an
indication; and
(b) the biological is included in the Register; and
(c) the indication is not an indication accepted in relation to that
inclusion.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Part 3-2A Biologicals
Division 3 Exemptions
Section 32C
Division 3—Exemptions
Subdivision A—Preliminary
32C What this Division is about
There are 4 kinds of exemptions in relation to biologicals:
(a) exemptions of biologicals under the regulations;
and
(b) exemptions of biologicals to deal with
emergencies; and
(c) exemptions of biologicals for special and
experimental uses; and
(d) exemptions of biologicals where substitutes are
unavailable.
Subdivision B—Exempting biologicals under the regulations
32CA Exempt biologicals
(1) The regulations may exempt specified persons from the operation
of Division 4 in relation to specified biologicals.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(2) The regulations may exempt specified biologicals from the
operation of Division 4.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
(3) An exemption under this section may be subject to conditions that
are prescribed in the regulations.
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Exemptions Division 3
Section 32CB
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
exemption under this section.
Penalty: 60 penalty units.
(5) If the regulations revoke an exemption, the revocation takes effect
on the day specified in the regulations. The day must not be earlier
than 28 days after the day on which the regulations revoking the
exemption take effect.
Subdivision C—Exempting biologicals to deal with emergencies
32CB Minister may make exemptions
(1) The Minister may, by writing, exempt specified biologicals from
the operation of Division 4.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: There are criminal offences and a civil penalty relating to biologicals
exempt under this section not conforming to standards etc.: see
section 32CJ.
(2) The Minister may make an exemption under subsection (1) only if
the Minister is satisfied that, in the national interest, the exemption
should be made so that:
(a) the biologicals may be stockpiled as quickly as possible in
order to create a preparedness to deal with a potential threat
to public health that may be caused by a possible future
emergency; or
(b) the biologicals can be made available urgently in Australia in
order to deal with an actual threat to public health caused by
an emergency that has occurred.
Period of exemption
(3) An exemption under subsection (1) comes into force:
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(a) on the day the exemption is made; or
(b) on a later day specified in the exemption.
(4) An exemption under subsection (1) remains in force for the period
specified in the exemption, unless revoked earlier.
Note: Section 32CD deals with variation and revocation of the exemption.
Effect of inclusion of biological in the Register
(5) An exemption under subsection (1) ceases to have effect in relation
to a particular biological when that biological becomes included in
the Register under Division 4.
Exemption not a legislative instrument
(6) An exemption under subsection (1) is not a legislative instrument.
32CC Conditions of exemptions
An exemption under section 32CB is subject to conditions
specified in the exemption about any of the following:
(a) the quantity of biologicals that are exempt;
(b) the source of those biologicals;
(c) the persons or class of persons who may import, export,
manufacture or supply those biologicals;
(d) the supply of those biologicals (including the persons or class
of persons to whom biologicals may be supplied for use and
the circumstances under which a stockpile of biologicals may
be supplied for use);
(e) the storage and security of those biologicals;
(f) the keeping and disclosure of, and access to, records about
those biologicals;
(g) the disposal of those biologicals;
(h) the manner in which any of those biologicals is to be dealt
with if a condition of the exemption is breached;
(i) any other matters that the Minister thinks appropriate.
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Section 32CD
Whether or not biologicals are exempt under section 32CB is not
affected by whether or not there is a breach of a condition under
this section in relation to those biologicals.
Note 1: There are criminal offences and civil penalties related to the breach of
a condition of an exemption: see sections 32CH and 32CI.
Note 2: Section 32CD deals with variation and revocation of the conditions.
32CD Variation or revocation of exemption
Variation of exemption
(1) The Minister may, by writing, vary an exemption made under
section 32CB by removing specified biologicals from the
exemption.
Note: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Revocation of exemption
(2) The Minister may, by writing, revoke an exemption made under
section 32CB.
Variation or revocation of conditions
(3) The Minister may, by writing:
(a) vary the conditions of an exemption made under
section 32CB (including by imposing new conditions); or
(b) revoke the conditions of an exemption made under
section 32CB.
When variation or revocation takes effect
(4) A variation or revocation under this section takes effect:
(a) if the Minister states in the variation or revocation that the
variation or revocation is necessary to prevent imminent risk
of death, serious illness or serious injury—on the day the
variation or revocation is made; or
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(b) in any other case—on a later day specified in the variation or
revocation (which must not be earlier than 28 days after the
day the variation or revocation is made).
32CE Informing persons of exemption etc.
If the Minister makes an exemption under section 32CB, the
Minister must take reasonable steps to give a copy of the following
to each person covered by paragraph 32CC(c):
(a) the exemption;
(b) any variation or revocation of the exemption under
section 32CD.
32CF Notification and tabling
Notification
(1) The Secretary must cause a notice setting out particulars of the
following:
(a) an exemption made under section 32CB because of
paragraph 32CB(2)(b);
(b) a variation or revocation under section 32CD, to the extent
that the variation or revocation relates to an exemption made
under section 32CB because of paragraph 32CB(2)(b);
to be published in the Gazette within 7 days after the day on which
the exemption, variation or revocation is made. However, the
exemption, variation or revocation is not invalid merely because of
a failure to comply with this subsection.
Tabling
(2) The Minister must cause a document setting out particulars of the
following:
(a) an exemption made under section 32CB because of
paragraph 32CB(2)(b);
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Section 32CG
(b) a variation or revocation under section 32CD, to the extent
that the variation or revocation relates to an exemption made
under section 32CB because of paragraph 32CB(2)(b);
to be tabled in each House of the Parliament within 5 sitting days
of that House after the day on which the exemption, variation or
revocation is made. However, the exemption, variation or
revocation is not invalid merely because of a failure to comply
with this subsection.
32CG Disposal of unused biologicals
(1) This section applies to a biological if:
(a) an exemption under section 32CB in relation to that
biological ceases to have effect otherwise than because that
biological becomes included in the Register under
Division 4; and
(b) that biological has not been used before the exemption so
ceases to have effect.
(2) The Secretary may arrange for the disposal of the biological in
accordance with the regulations.
(3) Regulations made for the purposes of subsection (2) may set out
the methods by which the biological is to be stored, supplied,
destroyed, exported or otherwise disposed of.
(4) A method set out in the regulations under subsection (3) must not
enable or permit any benefit to be conferred on a person (including
the Commonwealth) other than the owner of the biological.
32CH Criminal offences for breaching a condition of an exemption
(1) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
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(c) the act or omission results in the breach of a condition of the
exemption; and
(d) the act or omission is likely to cause a serious risk to public
health.
Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: Imprisonment for 4 years or 240 penalty units, or both.
(4) Strict liability applies to paragraph (3)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Penalty: 60 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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Section 32CI
32CI Civil penalty for breaching a condition of an exemption
A person contravenes this section if:
(a) the person does an act or omits to do an act in relation to a
biological; and
(b) the biological is covered by an exemption in force under
section 32CB; and
(c) the act or omission results in the breach of a condition of the
exemption.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32CJ Criminal offences and civil penalty for biologicals not
conforming to standards etc.
(1) This section applies if:
(a) a biological is exempt under section 32CB; and
(b) a person supplies a batch of the biologicals; and
(c) the Secretary is satisfied that the biologicals included in that
batch:
(i) do not conform to a standard applicable to the
biologicals; or
(ii) are otherwise not fit to be used for their intended
purposes.
(2) The Secretary may, by written notice given to the person, require
the person to take steps to recall the biologicals included in that
batch (except any of those biologicals that cannot be recalled
because they have been administered to, or applied in the treatment
of, a person).
(3) The notice may specify one or more of the following requirements:
(a) the steps to be taken to recall the biologicals;
(b) the manner in which the steps are to be taken;
(c) a reasonable period within which the steps are to be taken.
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(4) The Secretary must, as soon as practicable after giving the notice,
cause particulars of it to be published in the Gazette or on the
Department’s website.
Notice is not a legislative instrument
(5) A notice given under subsection (2) is not a legislative instrument.
Offences
(6) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement; and
(d) either:
(i) the use of any of the biologicals has resulted in, will
result in, or is likely to result in, harm or injury to any
person; or
(ii) the use of any of the biologicals, if any of the
biologicals were used, would result in, or would be
likely to result in, harm or injury to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
failed to comply with that requirement.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(7) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
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Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(9) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: 100 penalty units.
(10) An offence against subsection (9) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Civil penalty
(11) A person contravenes this subsection if:
(a) the Secretary gives a notice to the person under
subsection (2); and
(b) the notice specifies a particular requirement mentioned in
subsection (3); and
(c) the person does not comply with the requirement.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Saving of other laws
(12) This section is not intended to exclude or limit the operation of any
other law of the Commonwealth or any law of a State or Territory.
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Section 32CK
Subdivision D—Exempting biologicals for certain uses
32CK Approvals for importing, exporting or supplying a biological
for special and experimental uses
(1) The Secretary may, by notice in writing, grant an approval to a
person for one or more of the following:
(a) the importation into Australia of a specified biological;
(b) the exportation from Australia of a specified biological;
(c) the supply in Australia of a specified biological;
that is:
(d) for use in the treatment of another person; or
(e) for use solely for experimental purposes in humans.
(1A) An approval for use of the kind referred to in paragraph (1)(d) must
not be granted to a person unless the person is a health practitioner.
(2) Subsection (1) does not apply if the biological is included in the
Register, the person is exempt under subsection 32CA(1) in
relation to the biological or the biological is exempt under
subsection 32CA(2).
Application for approval
(3) An application for an approval for use of the kind referred to in
paragraph (1)(d) must:
(a) be made to the Secretary; and
(aa) be in a form (if any) approved, in writing, by the Secretary;
and
(b) be accompanied by such information relating to the
biological the subject of the application as is required by the
Secretary.
(4) An application for an approval for use of the kind referred to in
paragraph (1)(e) must:
(a) be made to the Secretary; and
(b) be made in writing; and
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(c) be accompanied by such information relating to the
biological the subject of the application as is required by the
Secretary; and
(d) be accompanied by the prescribed evaluation fee.
Secretary’s decision
(5) If an application for an approval is made, the Secretary must:
(a) after having considered the application; and
(b) in the case of an application for an approval for use of the
kind referred to in paragraph (1)(e)—after having evaluated
the information submitted with the application;
notify the applicant of the decision on the application as soon as
practicable after making the decision and, in the case of a decision
not to grant the approval, of the reasons for the decision.
Conditions
(6) The Secretary may grant an approval under subsection (1) subject
to any conditions that are specified in the notice of approval.
(7) Those conditions may include a condition relating to the charges
that may be made for the biological to which the approval relates.
This subsection does not limit subsection (6).
(8) An approval under subsection (1) for use of the kind referred to in
paragraph (1)(e) is subject to the conditions (if any) specified in the
regulations. Those conditions (if any) are in addition to any
conditions imposed under subsection (6).
(9) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
approval under subsection (1).
Penalty: 60 penalty units.
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Section 32CL
Approval not a legislative instrument
(10) An approval under subsection (1) is not a legislative instrument.
32CL Conditions of use of biological for experimental purposes in
humans
(1) The use by a person (the experimenter) for experimental purposes
in humans of a biological that is the subject of an approval:
(a) that is held by another person under subsection 32CK(1); and
(b) that covers the importation into Australia, or the supply in
Australia, of the biological for use solely for experimental
purposes in humans;
is subject to the conditions (if any) specified in the regulations
relating to one or more of the following:
(c) the preconditions on the use of the biological for those
purposes;
(d) the principles to be followed in the use of the biological for
those purposes;
(e) the monitoring of the use, and the results of the use, of the
biological for those purposes;
(f) the circumstances in which the experimenter must cease the
use of the biological for those purposes.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition
applicable under regulations made for the purposes of this
section.
Penalty for contravention of this subsection:60 penalty units.
32CM Exemptions for health practitioners
(1) The Secretary may, in writing, authorise a specified medical
practitioner to supply a specified biological, for use in the
treatment of humans, to the class or classes of recipients specified
in the authority.
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Section 32CM
Note: Section 32CN contains criminal offences relating to the giving an
authority to a medical practitioner.
(1A) An application for an authority under subsection (1) must be in a
form (if any) approved, in writing, by the Secretary.
(2) The Secretary may give an authority under subsection (1) subject
to any conditions that are specified in the authority.
(3) The Secretary may impose conditions (or further conditions) on an
authority given to a person under subsection (1) by giving to the
person written notice of the conditions (or further conditions).
(4) An authority under subsection (1) may only be given:
(a) to a medical practitioner included in a class of medical
practitioners prescribed by the regulations for the purposes of
this paragraph; or
(b) to a medical practitioner who has the approval of an ethics
committee to supply the specified biological.
Paragraph (b) does not apply in the exceptional circumstances (if
any) prescribed by the regulations for the purposes of this
subsection.
(5) An authority under subsection (1) may only be given in relation to
a class or classes of recipients prescribed by the regulations for the
purposes of this subsection.
(6) The regulations may prescribe the circumstances in which a
biological may be supplied under an authority under subsection (1).
(7) An authority under subsection (1) is not a legislative instrument.
(7A) The Minister may, by legislative instrument, make rules
authorising any health practitioner who is included in a specified
class of health practitioners to supply a specified biological, for use
in the treatment of humans, to the class or classes of recipients
specified in those rules, so long as:
(a) the biological is supplied in the circumstances specified in
those rules; and
(b) the conditions (if any) specified in those rules are satisfied.
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Section 32CM
(7B) In making rules under subsection (7A), the Minister must comply
with:
(a) such requirements (if any) as are prescribed by the
regulations; and
(b) such restrictions (if any) as are prescribed by the regulations;
and
(c) such limitations (if any) as are prescribed by the regulations.
(7C) If:
(a) a person is authorised, by subsection (7A) rules, to supply a
biological; and
(b) the person supplies the biological in accordance with those
rules;
the person must:
(c) notify the supply to the Secretary; and
(d) do so within 28 days after the supply.
(7D) A notification under subsection (7C) must:
(a) be in accordance with a form that is approved, in writing, by
the Secretary; and
(b) contain such information as is prescribed by the regulations.
(7E) An approval of a form may require or permit information to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(7F) A person commits an offence if:
(a) the person is subject to a requirement under subsection (7C);
and
(b) the person omits to do an act; and
(c) the omission breaches the requirement.
Penalty: 10 penalty units.
(7G) An offence against subsection (7F) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
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(7GA) Subsection (7F) does not apply in relation to a person and a
requirement to notify a supply of a biological if a health
practitioner, on behalf of the person, does the following:
(a) notifies the supply to the Secretary within 28 days after the
supply;
(b) makes the notification in accordance with the requirements
referred to in subsection (7D).
Note: A defendant bears an evidential burden in relation to the matter in
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
(7H) In recommending to the Governor-General that regulations should
be made for the purposes of paragraph (7D)(b), the Minister must
have regard to the principle that information should only be
prescribed for the purposes of that paragraph if the information is
reasonably required for the responsible scrutiny by the Secretary of
the operation of the scheme embodied in subsection (7A).
(8) In this section:
medical practitioner means a person who is registered, in a State
or internal Territory, as a medical practitioner.
32CN Criminal offences relating to the giving of an authority to a
health practitioner
(1) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6); and
(d) either:
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(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with the authority; or
(ii) the supply is not in accordance with the conditions to
which the authority is subject; or
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: 500 penalty units.
(4A) A person commits an offence if:
(a) the Secretary has authorised, under subsection 32CM(1), the
person to supply a biological; and
(b) the person supplies the biological; and
(c) any of the following applies:
(i) the supply is not in accordance with the authority;
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(ii) the supply is not in accordance with the conditions to
which the authority is subject;
(iii) the supply is not in accordance with regulations made
for the purpose of subsection 32CM(6).
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
(5) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules; and
(e) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because:
(i) the supply is not in accordance with those rules; or
(ii) the supply is not in the circumstances specified in those
rules; or
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(7) A person commits an offence if:
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Section 32CN
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 500 penalty units.
(8) A person commits an offence if:
(a) the person is a health practitioner; and
(b) the person is included in a class of health practitioners
specified in subsection 32CM(7A) rules; and
(c) the person supplies a biological specified in those rules; and
(d) any of the following applies:
(i) the supply is not in accordance with those rules;
(ii) the supply is not in the circumstances specified in those
rules;
(iii) the supply is not in accordance with the conditions
specified in those rules.
Penalty: 100 penalty units.
(9) An offence against subsection (8) is an offence of strict liability.
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Exemptions Division 3
Section 32CO
Subdivision E—Exempting biologicals where substitutes are
unavailable etc.
32CO Approvals where substitutes for biologicals are unavailable
etc.
(1) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
(c) therapeutic goods included in the Register that could act as a
substitute for the biological are unavailable or are in short
supply; and
(d) any of the following conditions is satisfied:
(i) the biological that is the subject of the application for
approval is registered or approved for general marketing
in at least one foreign country specified by the Secretary
under subsection (5);
(ii) an application that complies with section 32DA has
been made for inclusion of the biological in the
Register;
(iii) an application under section 32DD has been made for
inclusion of the biological in the Register, and the
application has passed preliminary assessment; and
(e) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
(1A) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
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Section 32CO
(c) therapeutic goods included in the Register that could act as a
substitute for the biological are unavailable or are in short
supply; and
(d) either:
(i) the biological that is the subject of the application for
approval is not registered or approved for general
marketing in any of the foreign countries specified by
the Secretary under subsection (5); or
(ii) the biological that is the subject of the application for
approval is registered or approved for general marketing
in at least one foreign country specified by the Secretary
under subsection (5), but is not readily available for
importation into, and supply in, Australia; and
(e) the biological is registered or approved for general marketing
in a foreign country; and
(f) the manufacturing and quality control procedures used in the
manufacture of the biological are acceptable; and
(g) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(h) the approval is necessary in the interests of public health.
(2) The Secretary may, by notice in writing, grant an approval to a
person for:
(a) the importation into Australia of a specified biological; or
(b) the importation into Australia of a specified biological and
the supply in Australia of that biological;
if the Secretary is satisfied that:
(c) there are no therapeutic goods that are included in the
Register that could act as a substitute for the biological; and
(d) either:
(i) an application that complies with section 32DA has
been made for inclusion of the biological in the
Register; or
(ii) an application under section 32DD has been made for
inclusion of the biological in the Register, and the
application has passed preliminary assessment; and
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(e) the biological is of a kind specified by the Secretary in a
determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
Application for approval
(3) An application for an approval must:
(a) be made to the Secretary; and
(b) be accompanied by such information relating to the
biological as is required by the Secretary.
Secretary’s decision
(4) If an application for an approval is made, the Secretary must, after
having considered the application, notify the applicant of the
decision on the application as soon as practicable after making the
decision and, in the case of a decision not to grant the approval, of
the reasons for the decision.
Determinations
(5) The Secretary may, by legislative instrument, make a
determination specifying foreign countries for the purposes of
subparagraph (1)(d)(i).
(6) The Secretary may, by legislative instrument, make a
determination specifying the kinds of biologicals that can be the
subject of an approval under this section.
Conditions
(7) The Secretary may grant an approval subject to any conditions that
are specified in the notice of approval.
(8) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of a condition of an
approval under subsection (1), (1A) or (2).
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Section 32CO
Penalty: 60 penalty units.
Period of approval
(9) The Secretary may grant an approval for such period as is specified
in the notice of approval.
When approval lapses
(10) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made on an application that has been
made for inclusion of the biological in the Register.
(11) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),
paragraph (1A)(c), (d), (e), (f), (g) or (h), or paragraph (2)(c),
(d), (e) or (f), as the case requires, no longer applies in
relation to the biological, or that a condition of the approval
has been contravened; and
(b) the Secretary has given to the person to whom the approval
was granted a notice stating that the Secretary is so satisfied.
(12) The lapsing of the approval on the expiry of the period specified in
the notice of approval does not prevent another approval being
granted under this section in relation to the biological before that
lapsing. The other approval may be expressed to take effect on the
expiry of that period.
Approval not a legislative instrument
(13) An approval under subsection (1), (1A) or (2) is not a legislative
instrument.
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Section 32D
Division 4—Including biologicals in the Register
Subdivision A—Preliminary
32D What this Division is about
A Class 1 biological can be included in the Register if a proper
application is made and the applicant certifies various matters.
A biological other than a Class 1 biological can be included in the
Register if a proper application is made and the Secretary is
satisfied the biological is suitable for inclusion following an
evaluation of the biological.
Subdivision B—Class 1 biologicals
32DA Application for inclusion in the Register
(1) A person may make an application to the Secretary to include a
Class 1 biological in the Register.
(2) An application must:
(a) be made in accordance with a form that is approved, in
writing, by the Secretary; and
(b) be accompanied by a statement certifying the matters
mentioned in subsection (3); and
(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
(3) The applicant must certify that:
(a) the biological is a Class 1 biological; and
(b) the biological is safe for the purposes for which it is to be
used; and
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(c) the biological conforms to every standard (if any) applicable
to it; and
(d) both of the following are complied with in relation to the
biological:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
(e) the biological complies with all prescribed quality or safety
criteria that are applicable to it; and
(f) the biological does not contain substances that are prohibited
imports for the purposes of the Customs Act 1901.
(4) An approval of a form may require or permit an application to be
given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32DB Inclusion of Class 1 biological in the Register
(1) If an application is made in accordance with section 32DA for a
Class 1 biological to be included in the Register in relation to a
person, the Secretary must include the biological in the Register in
relation to the person.
Biological number
(2) If the Secretary includes the biological in the Register, the
Secretary must assign a unique number to the biological. The
number assigned may be any combination of numbers and either or
both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(3) As soon as practicable after the biological has been included in the
Register, the Secretary must give to the applicant a certificate of
the inclusion of the biological in the Register.
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Section 32DC
(4) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register commences.
Duration of inclusion in the Register
(5) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
32DC Refusal to include Class 1 biological in the Register
If:
(a) an application is made under subsection 32DA(1) to include
a Class 1 biological in the Register; and
(b) the Secretary refuses the application;
the Secretary must, as soon as practicable after the refusal, give the
person notice of the refusal and of the reasons for the refusal.
Subdivision C—Biologicals other than Class 1 biologicals
32DD Application for inclusion in the Register
A person may make an application to the Secretary to include a
biological, other than a Class 1 biological, in the Register.
32DDA Preliminary assessment of applications
(1) If an application is made under section 32DD for the inclusion of a
biological in the Register, the Secretary must carry out an
assessment of whether the requirements set out in subsection (2) of
this section have been met in relation to the application.
(2) The requirements are as follows:
(a) the application must be made:
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(i) in accordance with the form approved, in writing, by the
Secretary for that class of biological; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that class of biological;
(b) the prescribed application fee for that class of biological must
be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (9) for that class
of biological; and
(ii) in a form determined under subsection (10) for that
class of biological;
(e) if the Secretary so requires—the applicant must:
(i) deliver to the Department a reasonable number of
samples of the biological; and
(ii) do so in a manner approved, in writing, by the
Secretary.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has passed preliminary assessment, the Secretary
must give a written notice to the applicant stating that the
application has passed preliminary assessment.
(5) Subsection (4) does not apply if the period within which the
Secretary must, under section 32DE, evaluate the biological to
which the application relates is prescribed by reference to the
prescribed period within which the Secretary is required to
consider an application under subsection 9D(3) to vary an entry in
the Register.
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Section 32DE
(6) If the application has not passed preliminary assessment, the
Secretary must, by written notice given to the applicant, refuse the
application.
Approval of different forms etc.
(7) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and manners for making applications for different
classes of biologicals that are prescribed by the regulations for the
purposes of section 32AA.
(8) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(9) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to a class of biological that is prescribed by
the regulations for the purposes of section 32AA.
(10) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to a class of biological that is prescribed by
the regulations for the purposes of section 32AA.
32DE Evaluation of biologicals
(1) If an application is made under section 32DD for a biological to be
included in the Register in relation to a person, and the application
has passed preliminary assessment, the Secretary must evaluate the
biological for inclusion in the Register, having regard to:
(a) whether the quality, safety and efficacy of the biological for
the purposes for which it is to be used have been
satisfactorily established; and
(b) whether the presentation of the biological is acceptable; and
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Section 32DEA
(c) whether the biological conforms to any standard applicable to
it; and
(d) whether:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code; and
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or the regulations;
are complied with in relation to the biological; and
(e) if a step in the manufacture of the biological has been carried
out outside Australia and the biological is not exempt from
the operation of Part 3-3—whether the manufacturing and
quality control procedures used in the step are acceptable;
and
(f) if a step in the manufacture of the biological has been carried
out in Australia, the biological is not exempt from the
operation of Part 3-3 and the person is not exempt from the
operation of that Part in relation to that step—whether that
step has been carried out in accordance with that Part; and
(g) whether the biological contains substances that are prohibited
imports for the purposes of the Customs Act 1901; and
(h) whether all of the manufacturers of the biological are
nominated as manufacturers of the biological in the
application; and
(i) such other matters (if any) as the Secretary considers
relevant.
(2) For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F)
and (2G) apply in a way corresponding to the way in which they
apply for the purposes of paragraph 25(1)(g).
32DEA Biologicals (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make biologicals (priority applicant)
determinations.
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(2) A biologicals (priority applicant) determination is a determination
that, for the purposes of this Act, a specified person is a priority
applicant in relation to any section 32DD application that may be
made by the person for the inclusion in the Register of a biological
specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for biologicals (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a biologicals (priority
applicant) determination;
(b) the consequences of the revocation of a biologicals (priority
applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) A period prescribed under paragraph 63(2)(daa) for the evaluation
of a biological covered by a section 32DD application for which
the applicant is a priority applicant may be shorter than the period
prescribed under that paragraph for the evaluation of a biological
covered by a section 32DD application for which the applicant is
not a priority applicant.
(7) The regulations may provide that, if:
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Section 32DF
(a) a person is a priority applicant in relation to a section 32DD
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a biologicals (priority applicant) determination is in force under
the regulations, the determination may be published on the
Department’s website.
(10) A biologicals (priority applicant) determination made under the
regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a biologicals (priority
applicant) determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
32DF Inclusion of biological in the Register
(1) If:
(a) an application is made under section 32DD for a biological to
be included in the Register in relation to a person; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary decides that it is appropriate to include the
biological in the Register after an evaluation under
section 32DE; and
(c) no part of an evaluation fee under section 32DI that is due
and payable by the person remains unpaid;
the Secretary must include the biological in the Register in relation
to the person.
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Section 32DG
Biological number
(2) If the Secretary includes the biological in the Register, the
Secretary must assign a unique number to the biological. The
number assigned may be any combination of numbers and either or
both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(3) As soon as practicable after the biological has been included in the
Register, the Secretary must give to the applicant a certificate of
the inclusion of the biological in the Register.
(4) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register commences.
Duration of inclusion in the Register
(5) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
32DG Refusal to include biological in the Register
If:
(a) an application is made under section 32DD to include a
biological in the Register; and
(aa) the application has passed preliminary assessment; and
(b) the Secretary refuses the application;
the Secretary must, as soon as practicable after the refusal, give the
person notice of the refusal and of the reasons for the refusal.
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Section 32DH
32DH Lapsing of application
(1) An application under section 32DD for inclusion of a biological in
the Register lapses if:
(a) any part of the evaluation fee payable in respect of the
biological remains unpaid at the end of the period of 42 days
after the day on which the part became due and payable; or
(b) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 32JA, is false or misleading in a material particular;
or
(c) the applicant fails to comply with a requirement under
section 32JA to give information consisting of patient data in
relation to the biological.
(2) In this section:
patient data, in relation to a biological, means information, derived
from clinical trials, relating to individuals before, during and after
the administration of the biological to those individuals, including,
but not limited to, demographic, biochemical and haematological
information.
32DI Evaluation fee
(1) If an application is made under section 32DD for a biological to be
included in the Register, and the application has passed preliminary
assessment, an evaluation fee specified in, or determined in
accordance with, the regulations is payable by the applicant in
respect of the evaluation of the biological for inclusion in the
Register.
(2) The Secretary must notify the applicant in writing of the amount of
the evaluation fee.
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32DJ When evaluation fee due for payment
(1) Subject to sections 32DK and 32DM, an evaluation fee payable by
an applicant is due and payable on the day on which the applicant
is notified of the amount of the evaluation fee.
(2) The evaluation fee is payable in the manner prescribed by the
regulations.
32DK Payment of evaluation fee by instalments
(1) The regulations may provide for the payment of an evaluation fee
to be made by such instalments and at such times as are ascertained
in accordance with the regulations, and the evaluation fee is due
and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide
that a person is not allowed to pay an evaluation fee by instalments if
any part of an instalment of that or any other evaluation fee payable
by the person was unpaid immediately after the time when it became
due for payment.
(3) If:
(a) the regulations make provision as mentioned in
subsection (2); and
(b) an instalment of an evaluation fee under section 32DI was
unpaid immediately after the time when it became due for
payment;
the balance of the evaluation fee becomes due and payable
immediately.
(4) Subsection (2) does not limit subsection (1).
32DL Recovery of evaluation fee
An evaluation fee may be recovered by the Commonwealth as a
debt due to the Commonwealth.
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Section 32DM
32DM Reduction of evaluation fee where evaluation not completed
within prescribed period
(1) Nothing in section 32DI, 32DJ or 32DK requires the applicant to
pay more than 3/4 of the evaluation fee before the completion of the
evaluation if a period is prescribed under paragraph 63(2)(daa) for
completing the evaluation.
(2) The Secretary must notify the applicant in writing of the day the
evaluation is completed.
(3) If the evaluation is not completed within that period, the evaluation
fee is 3/4 of the fee that, apart from this subsection, would have
been the evaluation fee.
(4) If:
(a) the evaluation is completed within that period; and
(b) part of the evaluation fee under section 32DI is unpaid when
the evaluation is completed;
that part becomes due and payable on the completion of the
evaluation.
(5) For the purposes of this section, if a copy of the evaluation report,
or a summary of that report, is given to either or both of the
following:
(a) the applicant;
(b) a committee established under the regulations to advise the
Secretary on applications to include biologicals in the
Register where a period for evaluating the biologicals is
prescribed under paragraph 63(2)(daa);
then the evaluation is taken to be completed immediately before
the first copy or summary is so given.
Note: This subsection has the effect that if the applicant withdraws the
application after being given a copy of the evaluation report, or a
summary of that report, before the end of that period, the full
evaluation fee is due and payable by the applicant.
(6) A notification under subsection (2) is not a legislative instrument.
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Section 32DN
Subdivision D—Transitional provisions for existing biologicals
32DN Transitional provisions for existing biologicals
Biologicals currently included in the Register
(1) If, immediately before the commencement of this section,
therapeutic goods that are a biological were included in relation to
a person:
(a) in the part of the Register for goods known as registered
goods; or
(b) in the part of the Register for goods known as listed goods; or
(c) in the part of the Register for medical devices included in the
Register under Chapter 4;
then, as soon as practicable after the commencement of this
section, the Secretary must:
(d) by writing, cancel the inclusion of the goods in that part; and
(e) include the biological in the Register under this Part in
relation to the person; and
(f) vary the Register as a result of that cancellation and
inclusion.
Pending applications
(2) If:
(a) before the commencement of this section, an application was
made for the registration or listing of therapeutic goods that
are a biological or for the inclusion of such goods in the
Register under Chapter 4; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application has not been, and is not, withdrawn either
before or after that commencement; and
(d) the application is successful when it is finally determined;
and
(e) the goods are included:
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(i) in the part of the Register for goods known as registered
goods; or
(ii) in the part of the Register for goods known as listed
goods; or
(iii) in the part of the Register for medical devices included
in the Register under Chapter 4;
then, as soon as practicable after that inclusion, the Secretary must:
(f) by writing, cancel the inclusion of the goods in that part; and
(g) include the biological in the Register under this Part in
relation to the person; and
(h) vary the Register as a result of that cancellation and
inclusion.
(3) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Notice of decisions
(4) The Secretary must give the person written notice of the
cancellation and inclusion under subsection (1) or (2).
Biological number
(5) If the Secretary includes the biological in the Register under
subsection (1) or (2), the Secretary must assign a unique number to
the biological. The number assigned may be any combination of
numbers and either or both of letters and symbols.
Note: The number assigned is the biological number of the biological.
Certificate
(6) As soon as practicable after the biological has been included in the
Register under this Part, the Secretary must give to the person a
certificate of the inclusion of the biological in the Register.
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Section 32DO
(7) The certificate must:
(a) specify the biological number of the biological; and
(b) specify the day on which the inclusion of the biological in the
Register under this Part commences.
Duration of inclusion in the Register
(8) The biological remains included in the Register in relation to the
person until the Secretary cancels the entry of the biological from
the Register under this Part.
Note: The biological is taken not to be included in the Register while it is
suspended: see section 32FD.
Annual charge
(9) If, during a financial year, the Secretary includes a biological in the
Register under subsection (1) or (2), subsection 4(1AA) of the
Therapeutic Goods (Charges) Act 1989 does not apply in relation
to the biological for that financial year.
No review of decisions
(10) A decision under this section is taken not to be an initial decision
for the purposes of section 60.
Subdivision E—Criminal offences and civil penalties
32DO Criminal offences for false statements in applications for
including biologicals in the Register
(1) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular;
and
(d) either:
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(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement; and
(b) the statement is made in, or in connection with, an
application for inclusion of a biological in the Register; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32DP Civil penalty for false statements in applications for including
biologicals in the Register
A person contravenes this section if the person in, or in connection
with, an application for inclusion of a biological in the Register,
makes a statement that is false or misleading in a material
particular.
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Section 32DQ
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32DQ Criminal offence and civil penalty for failing to notify adverse
effects etc. of biological while it is included in the Register
Criminal offence
(1) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person knows that particular information is information
of a kind to which subsection (3) applies; and
(c) the person fails to give that information to the Secretary
within the period specified in the regulations (whether or not
the person has already given to the Secretary other
information relating to the same matter).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
Civil penalty
(2) A person contravenes this subsection if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person knows that particular information is information
of a kind to which subsection (3) applies; and
(c) the person fails to give that information to the Secretary
within the period specified in the regulations (whether or not
the person has already given to the Secretary other
information relating to the same matter).
Maximum civil penalty:
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Section 32DR
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Relevant information
(3) This subsection applies to information of the following kinds:
(a) information that contradicts information already given by the
person under this Act in relation to the biological (including
information given about the quality, safety or efficacy of the
biologican( �
(b) information that indicates that the use of the biological in
accordance with the recommendations for its use may have
an unintended harmful effect;
(c) information that indicates that the biological, when used in
accordance with the recommendations for its use, may not be
as effective as the application for inclusion of the biological
in the Register or information already given by the person
under this Act suggests.
32DR Criminal offences and civil penalties for failing to notify
adverse effects etc. of biological where application
withdrawn or lapses
(1) If an application for inclusion of a biological in the Register is
withdrawn or lapses, the Secretary may, within 14 days after the
application is withdrawn or lapses, give the applicant written notice
requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is
aware of any information of a kind to which subsection (2)
applies; and
(b) if the applicant is aware of such information, to give the
information to the Secretary in writing.
(2) This subsection applies to information of the following kinds:
(a) information that contradicts information already given by the
person under this Act in relation to the biological (including
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information given about the quality, safety or efficacy of the
biologican( �
(b) information that indicates that the use of the biological in
accordance with the recommendations for its use may have
an unintended harmful effect;
(c) information that indicates that the biological, when used in
accordance with the recommendations for its use, may not be
as effective as the application for inclusion of the biological
in the Register or information already given by the person
under this Act suggests.
Offences
(3) A person commits an offence if:
(a) the Secretary gives a notice to the person under
subsection (1); and
(b) the person fails to comply with the notice within 30 days
after the notice is given to the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person gives information in purported compliance with a
notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
Civil penalties
(5) A person contravenes this subsection if:
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Section 32DS
(a) the Secretary gives a notice to the person under
subsection (1); and
(b) the person fails to comply with the notice within 30 days
after the notice is given to the person.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
(6) A person contravenes this subsection if:
(a) the person gives information in purported compliance with a
notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual—3,000 penalty units; and
(b) for a body corporate—30,000 penalty units.
Subdivision F—Advice from Gene Technology Regulator
32DS Consultation with Gene Technology Regulator
(1) This section applies to an application for inclusion of a biological
in the Register if the biological is, or contains, a GM product or a
genetically modified organism.
(2) Subject to subsection (5), the Secretary must give written notice to
the Gene Technology Regulator:
(a) stating that the application has been made; and
(b) requesting the Gene Technology Regulator to give advice
about the application.
(3) If the Secretary gives the Gene Technology Regulator a notice
under subsection (2), the Gene Technology Regulator may give
written advice to the Secretary about the application.
(4) The advice is to be given within the period specified in the notice.
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Section 32DT
(5) If an advice from the Gene Technology Regulator is in force under
section 32DT in relation to a class of biologicals, the Secretary is
not required to notify the Gene Technology Regulator under this
section in relation to an application for inclusion in the Register of
a biological belonging to that class.
(6) A notice under subsection (2) is not a legislative instrument.
32DT Secretary may seek advice about classes of GM products or
genetically modified organisms
(1) The Secretary may request advice from the Gene Technology
Regulator in relation to:
(a) biologicals that consist of, or that contain, a GM product
belonging to a class of GM products specified in the request;
or
(b) biologicals that consist of, or that contain, genetically
modified organisms belonging to a class of genetically
modified organisms specified in the request.
(2) A request for advice under subsection (1) must specify the matters
to which the advice is to relate.
(3) If the Secretary requests advice from the Gene Technology
Regulator under subsection (1), the Gene Technology Regulator
may provide written advice in relation to the matters specified in
the request.
(4) If the Gene Technology Regulator gives advice to the Secretary
under subsection (3), the advice remains in force until it is
withdrawn by the Gene Technology Regulator by written notice
given to the Secretary.
32DU Secretary to take advice into account
If the Secretary receives advice from the Gene Technology
Regulator:
(a) in response to a notice under section 32DS within the period
specified in the notice; or
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Section 32DU
(b) under section 32DT;
the Secretary must:
(c) ensure that the advice is taken into account in making a
decision on the application to which the notice relates, or on
an application to which the advice under section 32DT
relates, as the case requires; and
(d) inform the Gene Technology Regulator of the decision on the
application.
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Conditions Division 5
Section 32E
Division 5—Conditions
32E What this Division is about
Inclusions of biologicals in the Register are subject to certain
automatic conditions. The Minister and the Secretary may impose
further conditions.
32EA Conditions applying automatically
Entry and inspection powers
(1) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, any premises (including
premises outside Australia) at which that person or any
other person deals with the biological, complies with
record-keeping conditions under paragraph 32EC(2)(c)
or keeps documents that relate to the biological; and
(ii) while on those premises, to inspect those premises and
any biological on those premises and to examine, take
measurements of, conduct tests on or take samples of
any biological on those premises or any thing on those
premises that relates to any biological; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(iv) while on those premises, to inspect, and make copies of,
any records kept in compliance with a condition under
paragraph 32EC(2)(c); and
(v) while on those premises, to inspect, and make copies of,
any documents that relate to the biological; and
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Section 32EA
(b) if requested to do so by an authorised person, produce to the
person such documents relating to the biological included in
the Register as the person requires and allow the person to
copy the documents; and
(c) if requested to do so by an authorised person, make any
record kept in compliance with a condition under
paragraph 32EC(2)(c) available to the authorised person for
inspection:
(i) if the authorised person requires the record to be made
available immediately—immediately; and
(ii) if the authorised person requires the record to be made
available at or before a time specified by the authorised
person—at or before that time; and
(iii) in the form required by the authorised person.
(2) An authorised person is not authorised to enter premises as
mentioned in subsection (1) unless the person has shown his or her
identity card issued under section 52 if required by the occupier of
the premises. For the purposes of this subsection, occupier, in
relation to premises, includes a person present at the premises who
is in apparent control of the premises.
Delivery of samples
(3) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will deliver a reasonable number of
samples of the biological if the Secretary so requests:
(a) within the period, of not less than 14 days after the day the
request is made, specified in the request; and
(b) in accordance with any other requirements specified in the
request.
Manufacturing
(4) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will:
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Section 32EA
(a) if a manufacturer who was not nominated as a manufacturer
of the biological in the application for inclusion of the
biological in the Register is to become a manufacturer of a
step in the manufacture of the biological—inform the
Secretary in writing of that fact and of the name and address
of that manufacturer before that manufacturer begins to carry
out that step; and
(b) if premises that were not nominated in the application as
premises to be used in the manufacture of the biological are
to become premises used in a step in the manufacture of the
biological—inform the Secretary in writing of that fact and
of the name and address of the new premises before the
premises are first so used.
(5) The inclusion of a biological, other than a Class 1 biological, in the
Register is subject to a condition that:
(a) each step in the manufacture of the biological that is carried
out in Australia is carried out by a person who is the holder
of a licence to carry out that step or who is exempt from the
operation of Part 3-3 in relation to that step; and
(b) each step in the manufacture of the biological that is carried
out outside Australia is the subject of a certification in force
under subsection 32EB(2).
(6) Subsection (5) does not apply if the biological is exempt from the
operation of Part 3-3.
(7) Paragraph (5)(b) does not apply in relation to a step that was the
subject of the evaluation under section 32DE. This subsection
ceases to apply in relation to that step if either or both of the
following occur:
(a) that step begins to be carried out at premises that are different
from the premises in respect of which that evaluation was
conducted;
(b) that step begins to be carried out by a manufacturer that is
different from the manufacturer in respect of which that
evaluation was conducted.
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Division 5 Conditions
Section 32EB
Expiry date
(8) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will not supply a batch of the biological in
Australia, or export a batch of the biological from Australia, after
the expiry date for the biological.
Advertising
(9) The inclusion of a biological in the Register is subject to a
condition that the person in relation to whom the biological is
included in the Register will not, by any means, advertise the
biological for an indication other than an indication accepted in
relation to that inclusion.
32EB Certification of manufacturing steps outside Australia
(1) The person in relation to whom a biological, other than a Class 1
biological, is included in the Register may apply to the Secretary
for a certification under this section of a step in the manufacture of
the biological that is to be carried out outside Australia.
(2) If an application is made to the Secretary under this section, the
Secretary may, by writing, certify that the manufacturing and
quality control procedures used in that step are acceptable. The
Secretary must give the person written notice of the certification.
(3) In deciding whether to give the certification, subsections 25(2),
(2E), (2F) and (2G) apply in a way corresponding to the way in
which they apply for the purposes of paragraph 25(1)(g).
32EC Imposition of conditions by legislative instrument
(1) The inclusion of a biological in the Register is subject to the
conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination
setting out conditions for the purposes of subsection (1), being
conditions that relate to:
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Section 32ED
(a) the manufacture of the biological; or
(b) the custody, use, supply, disposal or destruction of the
biological; or
(c) the keeping of records relating to the biological; or
(ca) reporting requirements relating to the biological; or
(d) matters dealt with in, or matters additional to matters dealt
with in, standards applicable to the biological; or
(e) such other matters relating to the biological as the Minister
thinks appropriate.
(3) Without limiting subsection (2), different conditions may be
specified for different classes of biologicals.
32ED Imposition of conditions at time biological included in the
Register
(1) If the Secretary includes a biological in the Register in relation to a
person, the Secretary may, by notice in writing given to the person,
impose conditions on the inclusion of the biological in the
Register.
(2) A notice under subsection (1) is not a legislative instrument.
32EE Imposition or variation or removal of conditions after
biological included in the Register
(1) The Secretary may, by notice in writing given to the person in
relation to whom a biological is included in the Register, impose
new conditions on the inclusion or vary or remove conditions
imposed under section 32ED or this subsection.
(2) The Secretary’s power under subsection (1) may be exercised at
the request of the person concerned or on the Secretary’s own
initiative. A request must be accompanied by the prescribed fee.
(3) The imposition or variation or removal of a condition under
subsection (1) takes effect:
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Section 32EF
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 28 days
after the notice is given to the person, unless the person has
agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 28 days after the notice is given to the person, unless the
person has agreed to an earlier day; or
(b) in any other case—on a later day specified in the notice,
being a day not earlier than 28 days after the notice is given
to the person.
(3A) For the purposes of paragraphs (3)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
(4) A notice under subsection (1) is not a legislative instrument.
32EF Criminal offences for breach of condition
(1) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
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Section 32EG
(4) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32EG Civil penalty for breach of condition
A person contravenes this section if:
(a) a biological is included in the Register in relation to the
person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of
the biological in the Register.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Division 6 Suspension from the Register
Section 32F
Division 6—Suspension from the Register
32F What this Division is about
The Secretary may suspend biologicals from the Register in certain
circumstances. A biological that is suspended is taken not to be
included in the Register for most purposes.
32FA Suspension of biological from the Register
(1) The Secretary may, by written notice given to a person in relation
to whom a biological is included in the Register, suspend the
biological from the Register if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the biological continues to be included
in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the biological would not cause a potential
risk of death, serious illness or serious injury if the
biological were to continue to be included in the
Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the entry of the biological from the Register
under Division 7 (other than because of
paragraph 32GA(1)(a), (d) or (g)).
Notice of proposed suspension in some cases
(2) However, before suspending a biological from the Register
because it is likely that there are grounds for cancelling the entry of
the biological from the Register under section 32GC, the Secretary
must:
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Section 32FB
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed suspension within the
period specified in the notice (being not less than 28 days
after the day the notice is given).
(3) The Secretary must not make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
Period of suspension
(4) A notice under subsection (1) must specify the period of the
suspension (which must not exceed 6 months).
Note: Section 32FB deals with when the suspension takes effect and
extensions of the suspension.
Publication
(5) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
suspension.
Notice not a legislative instrument
(6) A notice under subsection (1) is not a legislative instrument.
32FB When suspension takes effect etc.
(1) A suspension under section 32FA takes effect:
(a) if the notice under subsection 32FA(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
(b) in any other case—on a later day specified in the notice,
being a day not earlier than 28 days after the notice is given
to the person.
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Part 3-2A Biologicals
Division 6 Suspension from the Register
Section 32FC
(2) The suspension has effect until:
(a) the Secretary revokes it under section 32FC; or
(b) the end of:
(i) the period specified under subsection 32FA(4); or
(ii) if the period is extended under subsection (3) of this
section—the period as so extended.
Extension of suspension
(3) The Secretary may, by written notice given to the person, extend
the period specified under subsection 32FA(4) by a further
specified period not exceeding 6 months.
Publication
(4) As soon as practicable after giving a notice under subsection (3),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
extension.
Notice not a legislative instrument
(5) A notice under subsection (3) is not a legislative instrument.
32FC Revocation of suspension
(1) The Secretary must revoke a suspension under section 32FA, by
written notice given to the person in relation to whom the
biological is included in the Register, if the Secretary is satisfied
that:
(a) the ground on which the biological was suspended from the
Register no longer applies; and
(b) there are no other grounds for suspending the biological from
the Register.
(2) The Secretary’s power to revoke the suspension may be exercised:
(a) if the person in relation to whom the biological is included in
the Register applies in writing to the Secretary; or
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Section 32FD
(b) on the Secretary’s own initiative.
Publication
(3) As soon as practicable after giving a notice under subsection (1),
the Secretary must cause to be published in the Gazette or on the
Department’s website a notice setting out particulars of the
revocation.
Notice of refusal to revoke suspension
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
Notice not a legislative instrument
(5) A notice under subsection (1) is not a legislative instrument.
32FD Effect of suspension
(1) If a biological is suspended from the Register under section 32FA,
the biological is taken, for the purposes of this Act (other than
section 32DQ, Division 5, sections 32FB and 32FC and
Divisions 7 and 9), not to be included in the Register while the
suspension has effect.
Note: Dealing in a biological that is not included in the Register may be a
criminal offence or may contravene a civil penalty provision: see
Division 2.
(2) While the suspension has effect, the Secretary’s power under
Division 7 to cancel the entry of the biological from the Register is
not affected.
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32G
Division 7—Cancellation from the Register
32G What this Division is about
The Secretary may cancel inclusions of biologicals in the Register
in certain circumstances.
32GA Immediate cancellation of biological from the Register in
various circumstances
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary is satisfied that there would be an imminent risk
of death, serious illness or serious injury if the biological
continued to be included in the Register; or
(b) the biological ceases to be a biological or the biological
becomes covered by an order under section 7 declaring goods
not to be therapeutic goods; or
(c) the person is exempt under subsection 32CA(1) in relation to
the biological or the biological is exempt under
subsection 32CA(2); or
(d) the person requests in writing the cancellation of the entry of
the biological from the Register; or
(e) the biological contains substances that are prohibited imports
for the purposes of the Customs Act 1901; or
(f) the Secretary is satisfied that a statement made in, or in
connection with, the application for including the biological
in the Register was false or misleading in a material
particular; or
(g) the annual charge payable under the Therapeutic Goods
(Charges) Act 1989 in respect of the inclusion of the
biological in the Register is not paid within 28 days after it
becomes payable; or
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Section 32GB
(h) the person has failed to comply with a condition mentioned
in subsection 32EA(1) or (3); or
(i) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the biological and the Secretary
is satisfied that the contravention is significant; or
(j) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
biological and the Secretary is satisfied that the contravention
is significant; or
(k) there is a breach, involving the biological, of an applicable
provision of the Therapeutic Goods Advertising Code or any
other requirement relating to advertising applicable under
Part 5-1 or under the regulations, and the Secretary is
satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the
biological is misleading to a significant extent.
(2) A notice under subsection (1) is not a legislative instrument.
32GB Immediate cancellation of biological from the Register after
failure to comply with information gathering notice
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary gives to the person a notice under section 32JA
requiring the person to give to the Secretary information, or
to produce to the Secretary documents, relating to the
biological; and
(b) the notice under section 32JA is given for the purposes of
ascertaining whether any of the certifications by the person
under subsection 32DA(3) in relation to the biological are
incorrect; and
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GC
(c) the person fails to comply with the notice under section 32JA
within a further 14 days after the end of the period specified
in that notice.
(2) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) the Secretary gives to the person a notice under section 32JA
requiring the person to give to the Secretary information, or
to produce to the Secretary documents, relating to whether
the biological is being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia; and
(b) either:
(i) the information or documents given are to the effect that
the biological is not being supplied in Australia,
imported into Australia or exported from Australia; or
(ii) the person fails to comply with the notice under
section 32JA within a further 14 days after the end of
the period specified in that notice.
(3) A notice under subsection (1) or (2) is not a legislative instrument.
32GC Cancellation of biological from the Register after notice of
proposed cancellation
(1) The Secretary may, by written notice given to the person in relation
to whom a biological is included in the Register, cancel the entry
of the biological from the Register if:
(a) it appears to the Secretary that the quality, safety or efficacy
of the biological is unacceptable or that the presentation of
the biological is not acceptable; or
(b) the biological has changed so that it has become separate and
distinct from the biological as so included; or
Note: Section 32AB deals with when a biological is separate and distinct from other biologicals.
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(c) the person has failed to comply with a condition to which the
inclusion of the biological is subject (except a condition
mentioned in subsection 32EA(1) or (3)); or
(d) the Secretary gives to the person a notice under section 32JA:
(i) that requires the person to give to the Secretary
information, or to produce to the Secretary documents,
relating to the biological; and
(ii) in respect of which section 32GB does not apply;
and the person fails to comply with that notice within a
further 14 days after the end of the period specified in that
notice; or
(e) the person contravenes subsection 32DQ(1) or (2) in relation
to the biological; or
(f) the biological does not conform to a standard applicable to it;
or
(fa) the person contravenes a direction, or a condition of a
direction, given to the person under subsection 42DV(1) in
relation to the advertising of the biological; or
(fb) if the person is a body corporate—a related body corporate of
the person contravenes a direction, or a condition of a
direction, given to the related body corporate under
subsection 42DV(1) in relation to the advertising of the
biological; or
(g) either of the following has not been complied with in relation
to the biological:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or under the regulations.
(2) However, before cancelling the entry of the biological from the
Register, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
cancellation and set out the reasons for it; and
(b) invite the person to make written submissions to the
Secretary in relation to the proposed cancellation within the
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Part 3-2A Biologicals
Division 7 Cancellation from the Register
Section 32GD
period specified in the notice (being not less than 28 days
after the day the notice is given).
(3) The Secretary must not make a decision relating to the proposed
cancellation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) A notice under subsection (1) is not a legislative instrument.
32GD Revocation of cancellation of biological upon request
(1) If:
(a) the Secretary cancels the entry of a biological from the
Register because of the request of a person made under
paragraph 32GA(1)(d); and
(b) before the end of the period of 90 days beginning on the day
the biological ceased to be included in the Register, the
person requests, in writing, the Secretary to revoke the
cancellation; and
(c) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
32GDA Revocation of cancellation of biological upon request—
payment of annual charge
(1) If:
(a) the Secretary cancels the entry of a biological from the
Register because the annual charge payable under the
Therapeutic Goods (Charges) Act 1989 in respect of the
inclusion of the biological in the Register was not paid within
28 days after it becomes payable; and
(b) before the end of the period of 90 days beginning on the day
the biological ceased to be included in the Register, the
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Section 32GE
person requests, in writing, the Secretary to revoke the
cancellation; and
(c) the annual charge payable under the Therapeutic Goods
(Charges) Act 1989 in respect of the inclusion of the
biological in the Register has been paid; and
(d) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke
the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to
have occurred.
32GE Publication of cancellation of entry from Register
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after cancelling an
entry of a biological from the Register, a notice setting out
particulars of the cancellation.
32GF Date of effect of cancellation of entries from Register
If the Secretary cancels an entry of a biological from the Register,
the cancellation has effect on the day on which the notice of
cancellation is given to the person in relation to whom the
biological was included in the Register.
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Division 8 Public notification, and recall, of biologicals
Section 32H
Division 8—Public notification, and recall, of biologicals
32H What this Division is about
The Secretary may require a person to recall biologicals, or to
inform the public about biologicals, that do not comply with
requirements or cannot lawfully be supplied. There are criminal
offences and a civil penalty for breaching such a requirement.
32HA Public notification, and recall, of biologicals
(1) The Secretary may, by notice in writing, impose requirements,
relating to a biological, on a person if:
(a) any of the circumstances referred to in the 2nd column of an
item in the following table occur in relation to the biological;
and
(b) the person is referred to in the 3rd column of that item.
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
1 It is supplied while it is included in the
Register, but the Secretary is satisfied that it
does not conform with a standard applicable to
it
The person in relation to
whom it is included in the
Register
2 It is a biological, other than a Class 1
biological, and it is supplied while it is included
in the Register, but the Secretary is satisfied
that the manufacturing principles have not been
observed in its manufacture
The person in relation to
whom it is included in the
Register
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Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
It is supplied while: The person supplying it
(a) the person is exempt under
subsection 32CA(1) in relation to the
biological or the biological is exempt under
subsection 32CA(2); or
(b) it is exempt under section 32CB; or
(c) it is the subject of an approval under
subsection 32CK(1); or
(d) it is the subject of an authority under
subsection 32CM(1) or (7A); or
(e) it is the subject of an approval under
subsection 32CO(1), (1A) or (2);
but the Secretary is satisfied that it does not
conform with a standard applicable to it
It is a biological, other than a Class 1 The person supplying it
biological, and it is supplied while:
(a) the person is exempt under
subsection 32CA(1) in relation to the
biological or the biological is exempt under
subsection 32CA(2); or
(b) it is exempt under section 32CB; or
(c) it is the subject of an approval under
subsection 32CK(1); or
(d) it is the subject of an authority under
subsection 32CM(1) or (7A); or
(e) it is the subject of an approval under
subsection 32CO(1), (1A) or (2);
but the Secretary is satisfied that the
manufacturing principles have not been
observed in its manufacture
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Part 3-2A Biologicals
Division 8 Public notification, and recall, of biologicals
Section 32HA
Circumstances in which requirements may be imposed
Item Circumstance relating to biological Person subject to
requirements
It is supplied while: The person supplying it
(a) it is not included in the Register; and
(b) the person is not exempt under
subsection 32CA(1) in relation to the
biological and the biological is not exempt
under subsection 32CA(2); and
(c) it is not exempt under section 32CB; and
(d) it is not the subject of an approval under
subsection 32CK(1); and
(e) it is not the subject of an authority under
subsection 32CM(1) or (7A); and
(f) it is not the subject of an approval under
subsection 32CO(1), (1A) or (2)
It is supplied while it is exempt under The person supplying it
section 32CB, and the Secretary is satisfied that
it is not fit to be used for its intended purpose
It is counterfeit goods (within the meaning of The person supplying it
section 42E)
8 It is a biological, other than a Class 1 The person in relation to
biological, and it is supplied while it is included whom it is included in the
in the Register, but the Secretary is satisfied Register
that there is a breach of the condition set out in
subsection 32EA(5)
9 It appears to the Secretary that the quality,
safety or efficacy of the biological is
unacceptable or that the presentation of the
biological is not acceptable
The person in relation to
whom the biological is
included in the Register
It has been suspended from the Register The person in relation to
whom it is included in the
Register
Its entry has been cancelled from the Register The person in relation to
whom it is included in the
Register
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Section 32HB
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within
such reasonable period as is specified, to recall the biological
that has been supplied;
(b) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, that the circumstances referred to in
paragraph (1)(a) have occurred in relation to the biological;
(ba) to inform the public or a specified class of persons, in the
specified manner and within such reasonable period as is
specified, of specified information, or of information of a
specified kind, relating to either or both of the following:
(i) the biological;
(ii) the circumstances referred to in paragraph (1)(a);
(c) to publish, in the specified manner and within such
reasonable period as is specified, specified information, or
information of a specified kind, relating to the manufacture
or supply of the biological;
(d) to notify the Secretary, in the specified manner and within
such reasonable period as is specified, of specified
information, or of information of a specified kind, relating to
the persons to whom the biological has been supplied.
(3) If the circumstances referred to in paragraph (1)(a) apply only to a
batch of the biological, the Secretary may limit the imposition of
the requirements to that batch.
(4) A requirement to recall a biological under this section does not
apply to a biological that cannot be recalled because it has been
administered to, or applied in the treatment of, a person.
(5) A notice under subsection (1) is not a legislative instrument.
32HB Publication of requirements
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after imposing a
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Part 3-2A Biologicals
Division 8 Public notification, and recall, of biologicals
Section 32HC
requirement under section 32HA, a notice setting out particulars of
the requirement.
32HC Criminal offences for non-compliance with requirements
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA; and
(c) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
32HD Civil penalty for non-compliance with requirements
A person contravenes this section if:
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Section 32HE
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches a requirement imposed on the
person under section 32HA.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32HE Powers of suspension and cancellation unaffected
Imposition of a requirement under section 32HA does not affect
the Secretary’s power to suspend a biological, or cancel the entry
of a biological, from the Register under this Part.
32HF Saving of other laws
This Division is not intended to exclude or limit the operation of
any other law of the Commonwealth or any law of a State or
Territory.
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Division 9 Obtaining information or documents
Section 32J
Division 9—Obtaining information or documents
Subdivision A—Preliminary
32J What this Division is about
The Secretary may by written notice seek information or
documents relating to:
• applications for inclusion of biologicals in the Register; or
• biologicals included in the Register; or
• the supply of, and other matters relating to, biologicals
covered by exemptions under Division 3.
There are criminal offences for failing to comply with a notice and
for giving false or misleading information or documents and civil
penalties for giving false or misleading information or documents.
Subdivision B—Obtaining information or documents for
biologicals included or proposed to be included in the
Register
32JA Secretary may require information or documents
(1) The Secretary may, by written notice given to a person:
(a) who is an applicant for the inclusion of a biological in the
Register; or
(b) in relation to whom a biological is included in the Register;
or
(c) in relation to whom a biological was, at any time during the
previous 5 years, included in the Register;
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Section 32JA
require the person to give to the Secretary information, or to
produce to the Secretary documents, that are relevant to one or
more of the following:
(d) the formulation of the biological;
(e) the composition of the biological;
(f) the design specifications of the biological;
(g) the quality of the biological;
(h) the method and place of manufacture or preparation of the
biological and the procedures employed to ensure that proper
standards are maintained in the manufacture and handling of
the biological;
(i) the presentation of the biological;
(j) the safety and efficacy of the biological for the purposes for
which it is to be used;
(k) whether the biological conforms with a standard applicable to
it;
(l) whether the biological complies with conditions (if any) on
the inclusion of the biological in the Register;
(m) whether either of the following has not been complied with in
relation to the biological:
(i) an applicable provision of the Therapeutic Goods
Advertising Code;
(ii) any other requirement relating to advertising applicable
under Part 5-1 or under the regulations;
(n) if the biological is included in the Register in relation to the
person—whether the biological is being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
(o) the regulatory history of the biological in another country;
(p) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
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Division 9 Obtaining information or documents
Section 32JB
(2) The person must give the information, or produce the documents,
to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JB contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JC contains a civil penalty for giving false or
misleading information or documents.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) If a notice is given under subsection (1) to a person covered by
paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to
which they are relevant) apply in relation to that part of the period
of 5 years before the notice was given during which the biological
was included in the Register.
32JB Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(aa) the person is covered by paragraph 32JA(1)(b) or (c); and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
Note: Failure to comply with the notice might also lead to suspension or
cancellation of the entry of a biological in the Register (see
Divisions 6 and 7).
(1A) Subsection (1) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (1A): see subsection 13.3(3) of the Criminal Code.
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Section 32JB
(1B) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(b) the person is covered by paragraph 32JA(1)(b) or (c); and
(c) the person fails to comply with the notice.
Penalty: 100 penalty units.
(1C) An offence against subsection (1B) is an offence of strict liability.
(1D) Subsection (1B) does not apply if the person has a reasonable
excuse.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (1D): see subsection 13.3(3) of the Criminal Code.
(2) A person commits an offence if:
(a) the person is given a notice under section 32JA in relation to
a biological; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular; and
(d) either:
(i) the use of the biological has resulted in, will result in, or
is likely to result in, harm or injury to any person; or
(ii) the use of the biological, if the biological were used,
would result in, or would be likely to result in, harm or
injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (5) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(5) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
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Section 32JC
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(6) A person commits an offence if:
(a) the person is given a notice under section 32JA; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(7) An offence against subsection (6) is an offence of strict liability.
32JC Civil penalty for giving false or misleading information or
document in compliance with a notice
A person contravenes this section if:
(a) the person is given a notice under section 32JA; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32JD Self-incrimination
(1) A person is not excused from giving information or producing a
document under section 32JA on the ground that the information or
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Section 32JE
the production of the document might tend to incriminate the
person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; and
(b) giving the information or producing the document; and
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
are not admissible in evidence against the individual:
(d) in criminal proceedings, except proceedings for an offence
against subsection 32JB(1), (1B), (2), (5) or (6); or
(e) in civil proceedings, except proceedings under section 42Y
for a contravention of section 32JC.
Subdivision C—Obtaining information or documents for
biologicals covered by exemptions
32JE Secretary may require information etc. about biologicals
exempt under the regulations
(1) If a person is exempt under subsection 32CA(1) in relation to a
biological, the Secretary may give the person a written notice
requiring the person to give to the Secretary specified information,
or to produce to the Secretary specified documents, relating to one
or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
(2) If a biological is exempt under subsection 32CA(2), the Secretary
may give the sponsor of the biological a written notice requiring
the sponsor to give to the Secretary specified information, or to
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produce to the Secretary specified documents, relating to one or
more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(3) A person given a notice under subsection (1) or (2) must give the
information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(4) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JF Secretary may require information etc. about biologicals
exempt to deal with emergencies
(1) This section applies to a person who is required to comply with a
condition of an exemption of a biological under section 32CB.
(2) The Secretary may, by written notice given to the person, require
the person to give to the Secretary specified information, or to
produce to the Secretary specified documents, relating to one or
more of the following:
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Section 32JG
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
(3) The person must give the information, or produce the documents,
to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(4) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JG Secretary may require information etc. about biologicals
exempt for special and experimental uses
Approval under subsection 32CK(1)
(1) The Secretary may give to a person who is granted an approval
under subsection 32CK(1) in relation to a biological a written
notice requiring the person to give to the Secretary specified
information, or to produce to the Secretary specified documents,
relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
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(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Approval under subsection 32CK(1)—use by another person
(2) The Secretary may give to a person (the experimenter) using a
biological that is the subject of an approval:
(a) that is held by another person under subsection 32CK(1); and
(b) that covers the importation into Australia, or the supply in
Australia, of the biological for use solely for experimental
purposes in humans;
a written notice requiring the experimenter to give to the Secretary
specified information, or to produce to the Secretary specified
documents, relating to either or both of the following:
(c) the use of the biological;
(d) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Authority under subsection 32CM(1)
(3) The Secretary may give to a person who is granted an authority
under subsection 32CM(1) in relation to a biological a written
notice requiring the person to give to the Secretary specified
information, or to produce to the Secretary specified documents,
relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
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Section 32JH
Authority under subsection 32CM(7A) rules
(3A) If a person is authorised, by subsection 32CM(7A) rules, to supply
a biological, the Secretary may give the person a written notice
requiring the person to give the Secretary specified information, or
to produce to the Secretary specified documents, relating to one or
more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(4) A person given a notice under subsection (1), (2), (3) or (3A) must
give the information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(5) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JH Secretary may require information etc. about biologicals
exempt where substitutes are unavailable etc.
(1) The Secretary may give to a person who is granted an approval
under subsection 32CO(1), (1A) or (2) in relation to a biological a
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written notice requiring the person to give to the Secretary
specified information, or to produce to the Secretary specified
documents, relating to one or more of the following:
(a) the supply of the biological;
(b) the handling of the biological;
(c) the monitoring of the supply of the biological;
(d) the results of the supply of the biological;
(e) any other matter prescribed by the regulations for the
purposes of this paragraph in relation to a biological of that
kind.
Compliance
(2) A person given a notice under subsection (1) must give the
information, or produce the documents, to the Secretary:
(a) within the period, of not less than 14 days after the day the
notice is given, specified in the notice; and
(b) in the form specified in the notice.
Note: Section 32JI contains criminal offences for failing to comply with the
notice and for giving false or misleading information or documents
and section 32JJ contains a civil penalty for giving false or misleading
information or documents.
(3) The form may require or permit the information to be given, or the
documents to be produced, in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
32JI Criminal offences for failing to comply with a notice etc.
(1) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person fails to comply with the notice.
Penalty: 500 penalty units.
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Section 32JJ
(1A) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person fails to comply with the notice.
Penalty: 100 penalty units.
(1B) An offence against subsection (1A) is an offence of strict liability.
(2) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
Note: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(3) A person commits an offence if:
(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Penalty: 100 penalty units.
(4) An offence against subsection (3) is an offence of strict liability.
32JJ Civil penalty for giving false or misleading information or
document in compliance with a notice
A person contravenes this section if:
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(a) the person is given a notice under section 32JE, 32JF, 32JG
or 32JH; and
(b) the person gives information or produces a document in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
32JK Self-incrimination
(1) A person is not excused from giving information or producing a
document under section 32JE, 32JF, 32JG or 32JH on the ground
that the information or the production of the document might tend
to incriminate the person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; and
(b) giving the information or producing the document; and
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
are not admissible in evidence against the individual:
(d) in criminal proceedings, except proceedings for an offence
against subsection 32JI(1), (1A), (2) or (3); or
(e) in civil proceedings, except proceedings under section 42Y
for a contravention of section 32JJ.
Subdivision D—Inspecting, copying and retaining documents
32JL Secretary may inspect and copy documents
The Secretary may inspect a document produced under
section 32JA, 32JE, 32JF, 32JG or 32JH and may make and retain
copies of the whole or a part of the document.
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Section 32JM
32JM Secretary may retain documents
(1) The Secretary may take possession of a document produced under
section 32JA, 32JE, 32JF, 32JG or 32JH, and retain it for as long
as is reasonably necessary.
(2) The person otherwise entitled to possession of the document is
entitled to be supplied, as soon as practicable, with a copy certified
by the Secretary to be a true copy.
(3) The certified copy must be received in all courts and tribunals as
evidence as if it were the original.
(4) Until a certified copy is supplied, the Secretary must provide the
person otherwise entitled to possession of the document, or a
person authorised by that person, reasonable access to the
document for the purposes of inspecting and making copies of the
whole or a part of the document.
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Section 33A
Part 3-3—Manufacturing of therapeutic goods
33A Application of this Part to medical devices
This Part does not apply to a medical device unless Part 3-2 applies
to the device.
Note: Section 15A sets out when Part 3-2 applies to a medical device.
33B Application of this Part to biologicals
This Part does not apply to a Class 1 biological.
34 Exempt goods and exempt persons
(1) The regulations may exempt therapeutic goods or a class of
therapeutic goods identified in the regulations from the operation
of this Part.
(2) The regulations may exempt a person identified in the regulations
from the operation of this Part in relation to the manufacture or a
step in the manufacture of therapeutic goods or a class of
therapeutic goods identified in the regulations.
(3) Where the regulations revoke an exemption, the revocation takes
effect on the day, not being earlier than 28 days after the day on
which the regulations are made, as is specified in the regulations.
35 Criminal offences relating to manufacturing therapeutic goods
(1) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
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(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(e) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
carried out the step in the manufacture of the goods.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
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Section 35
(4A) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods (other than goods exempt
under section 18A or 32CB); and
(b) the goods are for supply for use in humans; and
(c) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: 100 penalty units.
(4B) An offence against subsection (4A) is an offence of strict liability.
(5) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises; and
(e) either:
(i) the use of the goods has resulted in, will result in, or is
likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would
result in, or would be likely to result in, harm or injury
to any person; and
(f) the harm or injury has resulted, will result, is likely to result,
would result, or would be likely to result, because the person
carried out the step in the manufacture of the goods.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Section 35A
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (9) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(9) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(10) A person commits an offence if:
(a) the person, at premises in Australia, carries out a step in the
manufacture of therapeutic goods; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Penalty: 100 penalty units.
(11) An offence against subsection (10) is an offence of strict liability.
35A Civil penalties relating to manufacturing therapeutic goods
(1) A person contravenes this subsection if:
(a) the person carries out a step in the manufacture of therapeutic
goods at premises in Australia; and
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Section 35B
(b) the goods are for supply for use in humans; and
(c) the goods are not exempt under section 18A or 32CB; and
(d) none of the following applies:
(i) the goods are exempt goods;
(ii) the person is an exempt person in relation to the
manufacture of the goods;
(iii) the person is the holder of a licence that is in force that
authorises the carrying out of that step in relation to the
goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) A person contravenes this subsection if:
(a) the person carries out a step in the manufacture of therapeutic
goods at premises in Australia; and
(b) the goods are for supply for use in humans; and
(c) the goods are exempt under section 18A or 32CB; and
(d) the person is not the holder of a licence that:
(i) is in force; and
(ii) authorises the carrying out of that step in relation to the
goods at those premises.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
35B Criminal offences relating to breaching a condition of a licence
(1) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence; and
(d) the act or omission has resulted in, will result in, or is likely
to result in, harm or injury to any person.
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Section 35C
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
(4) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
35C Civil penalty relating to breaching a condition of a licence
A person contravenes this section if:
(a) the person holds a licence; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the licence.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
36 Manufacturing principles
(1) The Minister may, from time to time, determine written principles
to be observed in the manufacture of therapeutic goods for use in
humans.
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Section 37
(2) The manufacturing principles may relate to:
(a) the standards to be maintained, and the equipment to be used,
at premises used for the manufacturing of therapeutic goods
for use in humans; or
(b) procedures for quality assurance and quality control to be
employed in the manufacturing of therapeutic goods for use
in humans; or
(c) the qualifications and experience required of persons
employed in the manufacture of therapeutic goods for use in
humans; or
(d) the manufacturing practices to be employed in the
manufacturing of therapeutic goods for use in humans; or
(e) other matters relevant to the quality, safety and efficacy of
therapeutic goods for use in humans that are manufactured in
Australia;
and may include codes of good manufacturing practice.
(4) Manufacturing principles are legislative instruments.
37 Application for licence
(1) An application for a licence must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods
that the applicant proposes to manufacture; and
(c) in accordance with subsections (1A) and (1B), identify one or
more manufacturing sites that will be used in the
manufacture of those goods; and
(d) identify the steps in the manufacture of those goods that the
applicant proposes to carry out under the licence; and
(da) if the applicant proposes to carry out steps in the manufacture
of blood or blood components under the licence—contain
information relating to those steps set out in regulations made
for the purposes of this paragraph; and
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(e) state the names, qualifications and experience of the persons
who are to have control of the production of the goods and of
the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the
form; and
(g) be accompanied by the prescribed application fee.
Manufacturing sites
(1A) Subject to subsection (1B), an application under subsection (1)
must relate to one manufacturing site only. This does not prevent
other applications from relating to other manufacturing sites.
(1B) If an applicant is of the view that, having regard to the guidelines
under section 38A, a licence could be granted covering 2 or more
manufacturing sites, the applicant may:
(a) identify those sites in the application; and
(b) state the applicant’s reasons for the applicant’s view.
Further information
(2) The Secretary may, by notice in writing given to an applicant for a
licence, require the applicant:
(a) to give to the Secretary, within such reasonable time as is
specified in the notice, such further information concerning
the application as is specified in the notice; or
(b) to allow an authorised person, at any reasonable time
specified in the notice, to inspect each manufacturing site
identified in the application and the equipment, processes and
facilities that will be used in the manufacture of the goods, or
other goods at that site.
Applications or information may be given electronically
(3) An approval of a form mentioned in paragraph (1)(a), or a notice
mentioned in subsection (2), may require or permit an application
or information to be given in accordance with specified software
requirements:
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(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
38 Grant of licence
(1) Where:
(a) a person has made an application to carry out steps in the
manufacture of therapeutic goods at one or more
manufacturing sites; and
(b) the prescribed application fee has been paid; and
(c) any applicable prescribed inspection fees have been paid; and
(d) the applicant has complied with any requirements made by
the Secretary under subsection 37(2) in relation to the
application;
the Secretary must grant the applicant a licence covering one or
more manufacturing sites specified in the licence unless the
Secretary is satisfied that:
(e) the applicant will be unable to comply with the
manufacturing principles; or
(f) one or more of the manufacturing sites identified in the
application are not satisfactory for the manufacture of the
goods; or
(g) at least one of the following persons:
(i) the applicant;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the applicant’s affairs;
(iii) if the applicant is a body corporate—a major interest
holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
the conduct resulting in that subparagraph applying
occurred when the person was a manager or major
interest holder of the body corporate; or
(h) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
Interpretation
(1A) A reference in paragraph (1)(g) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
(1B) In paragraph (1)(g):
manufacturing licence means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating
to therapeutic goods, relating to manufacturing therapeutic
goods.
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Special circumstances justifying grant of licence
(2) Notwithstanding paragraph (1)(g), the Secretary may grant a
licence to an applicant who, apart from this subsection, could not
be granted a licence because of that paragraph if, in the opinion of
the Secretary, special circumstances make it appropriate to do so.
Guidelines
(2A) The Secretary must have regard to the guidelines under
section 38A in granting licences under this section.
What the licence authorises
(2B) For each manufacturing site covered by a licence, the Secretary
must authorise, in the licence, the holder of the licence to carry out
specified steps in the manufacture of specified therapeutic goods at
that manufacturing site.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: Sections 40A and 40B deal with variation of authorisations.
Notice of decision
(3) Where the Secretary grants or refuses to grant a licence to an
applicant, the Secretary must:
(a) give the applicant written notice of the decision; and
(b) in the case of a refusal—include in the notice the reasons for
the refusal.
Publication
(4) Where the Secretary grants a licence, the Secretary must cause
particulars of the decision to be published in the Gazette or on the
Department’s website as soon as is practicable after the decision is
made.
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Section 38A
38A Guidelines for multi-site licences
The Secretary must, by legislative instrument, make guidelines
setting out the circumstances in which a licence may cover 2 or
more manufacturing sites.
38B Splitting multi-site licences
(1) This section applies if a licence (the old licence):
(a) either:
(i) was in force under this Part immediately before the
commencement of this section; or
(ii) was suspended under this Part immediately before that
commencement; and
(b) related to premises that comprise 2 or more sites (the old
sites).
(2) As soon as practicable after the commencement of this section, the
Secretary must:
(a) by writing, revoke the old licence; and
(b) on the day that the Secretary revokes the old licence, grant
new licences (each of which is a new licence) to the holder of
the old licence which, when considered together, cover the
old sites.
The Secretary must give the holder written notice of the revocation
and grant.
Note: Subsections (5) and (6) deal with when each new licence commences
and when the old licence ends.
Guidelines
(3) The Secretary must have regard to the guidelines under
section 38A in granting licences under this section.
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Application of this Part
(4) Subject to this section, subsections 38(2B) and (4) and sections 39
to 41A apply to a new licence in the same way as they apply to a
licence granted under section 38.
Note: This means, for example, that:
(a) the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and
(b) the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and
(c) the Secretary may revoke or suspend a new licence under section 41.
Commencement of new licence
(5) The day specified under subsection 39(1) for the commencement
of each new licence granted to the holder of the old licence must be
the day (the transition day) after the day each new licence is
granted.
Note: Subsection (7) deals with suspending a new licence from the transition
day.
When revocation of old licence takes effect
(6) The revocation of the holder’s old licence takes effect immediately
before the start of the transition day.
Suspension of new licence
(7) If:
(a) subparagraph (1)(a)(ii) applies in relation to an old licence;
and
(b) the period of suspension of the old licence is due to end at the
end of a day (the relevant day) after the transition day;
the Secretary may, on the day that the Secretary grants a new
licence to the holder of the old licence and by notice in writing
given to the holder, suspend the new licence for a period starting
on the transition day and ending at the end of the relevant day.
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(8) Subsection 41(2) does not apply in relation to a suspension under
subsection (7) of this section. However, subsections 41(4) to (6) do
apply in relation to the suspension.
(9) To avoid doubt, subsection (7) does not prevent subsection 41(1)
from applying in relation to a new licence.
Licence charges
(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does
not apply in relation to a new licence for the financial year in
which the new licence is granted.
No review of revocation of old licence
(11) The revocation of the old licence is taken not to be an initial
decision for the purposes of section 60.
39 Term of licence
(1) A licence commences on the day specified in the licence and
remains in force until it is revoked or suspended.
(2) If:
(a) the licence covers therapeutic goods that are exempt under
section 18A; and
(b) those goods cease to be exempt under that section before the
licence is revoked;
the licence ceases to be in force in relation to those goods when
those goods cease to be exempt under that section.
Note: An exemption under section 18A may cease to have effect only in
relation to some of the goods covered by the exemption, see
subsection 18A(5).
(3) If:
(a) the licence covers a biological that is exempt under
section 32CB; and
(b) the biological ceases to be exempt under that section before
the licence is revoked;
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the licence ceases to be in force in relation to the biological when
the biological ceases to be exempt under that section.
Note: An exemption under section 32CB may cease to have effect only in
relation to some of the biologicals covered by the exemption: see
subsections 32CB(5) and 32CD(1).
40 Conditions of licences
(1) A licence may be granted subject to such conditions relating to the
manufacture of the goods as the Secretary thinks appropriate.
(2) The Secretary may, by notice in writing given to the holder of a
licence, impose new conditions on the licence or vary or remove
existing conditions.
(3) The imposition, variation or removal of a condition under
subsection (2) takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(b) in any other case—on the day specified in the notice, which
must be at least 28 days after the notice is given to the
person, unless the person has agreed to an earlier day.
(3A) For the purposes of paragraph (3)(b), the earlier day must not be
earlier than the day the notice is given to the person.
(4) In addition to any conditions imposed under subsection (1) or (2),
each licence is, except as otherwise specified in the licence, subject
to the conditions that the holder of the licence will:
(a) ensure that:
(i) the goods conform to any standard applicable to the
goods; and
(ii) the holder of the licence observes the manufacturing
principles in carrying out any steps in the manufacture
of the goods under the licence;
unless:
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(iii) the goods are a biological and are for supply after the
circumstances prescribed by the regulations for the
purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have
occurred; or
(iv) the goods are a biological and are for export after the
circumstances prescribed by the regulations for the
purposes of paragraphs 14(13A)(b) and 14A(3A)(b)
have occurred; and
(aa) if:
(i) the holder of the licence carries out, or proposes to carry
out, steps in the manufacture of blood or blood
components under the licence; and
(ii) regulations made for the purposes of this paragraph set
out particular information relating to those steps;
comply with a request by the Secretary to provide such
information, in accordance with those regulations; and
(ab) as soon as the holder of the licence becomes aware of
information of a kind mentioned in subsection (5), give the
information to the Secretary in writing; and
(ac) give the Secretary the information specified in a notice under
subsection (6) within the period, and in the manner, specified
in the notice; and
(b) allow an authorised person:
(i) to enter, at any reasonable time, each manufacturing site
covered by the licence; and
(ii) while at such a site, to inspect the site, any therapeutic
goods at the site and the processes relating to the
manufacture of therapeutic goods at the site and to
examine, take measurements of, conduct tests on or take
samples of any therapeutic goods at the site or any thing
at the site that relates to any therapeutic goods; and
(iii) while at such a site, to make any still or moving image
or any recording of that site or those goods or processes;
and
(c) where an authorised person enters a site as mentioned in
subparagraph (b)(i), require the holder or his or her
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employees at that site to answer questions relating to
procedures carried out at that site; and
(d) if requested to do so by an authorised person:
(i) produce to the person such documents relating to the
manufacture of therapeutic goods manufactured at that
site as the person requires and allow the person to copy
the documents; or
(ii) produce to the person for examination any batch
samples kept by the holder; and
(e) comply with such other conditions (if any) as are specified in
the regulations for the purposes of this section.
(5) The information with which paragraph (4)(ab) is concerned is
information of the following kinds:
(a) information that indicates that the use of the goods in
accordance with the recommendations for their use may have
an unintended harmful effect;
(b) information that indicates that the goods, when used in
accordance with the recommendations for their use, may not
be as effective as was suggested by:
(i) the application for registration or listing of the goods; or
(ii) information already furnished by the holder of the
licence under this Act; or
(iii) if the holder of the licence is not the sponsor of the
goods—information already furnished by the sponsor of
the goods under this Act;
(c) information that indicates that the quality, safety or efficacy
of the goods is unacceptable.
(6) The Secretary may, by notice in writing given to the holder of a
licence, require the holder to give the Secretary, within the
specified period and in the specified manner, specified information
to be used by the Secretary in deciding whether to revoke or
suspend the licence under section 41 in the circumstances referred
to in paragraph 41(1)(a).
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(7) The period specified in a notice given under subsection (6) must be
at least 14 days after the notice is given.
40A Variation of manufacturing site authorisations—Secretary’s
own initiative
(1) The Secretary may, on his or her own initiative and by notice in
writing given to the holder of a licence, vary a manufacturing site
authorisation in relation to the licence.
(2) A variation under subsection (1) takes effect:
(a) if the notice states that the variation is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the holder; or
(b) in any other case—on the day specified in the notice (which
must not be earlier than 28 days after the notice is given to
the holder).
40B Variation of licences—application by licence holder
Addition of manufacturing sites
(1) If the holder of a licence is of the view that, having regard to the
guidelines under section 38A, the licence could cover one or more
additional manufacturing sites, the holder may apply to the
Secretary for a variation of the licence so that it covers one or more
additional manufacturing sites specified in the application.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods
that the holder proposes to manufacture at each additional
manufacturing site specified in the application; and
(c) identify the steps in the manufacture of those goods that the
holder proposes to carry out under the licence; and
(d) if the holder proposes to carry out steps in the manufacture of
blood or blood components under the licence—contain
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information relating to those steps set out in regulations made
for the purposes of paragraph 37(1)(da); and
(e) state the names, qualifications and experience of the persons
who are to have control of the manufacture of the goods and
of the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the
form; and
(g) be accompanied by the prescribed application fee.
(3) If an application is made under subsection (1) and any applicable
prescribed inspection fees have been paid, the Secretary may, by
notice in writing given to the holder of the licence, vary the licence
so that the licence covers each additional manufacturing site
specified in the notice.
(4) For each manufacturing site specified under subsection (3), the
Secretary must, in the notice under that subsection, vary the licence
to authorise the holder of the licence to carry out specified steps in
the manufacture of specified therapeutic goods at that
manufacturing site.
Note 1: For specification by class, see subsection 33(3AB) of the Acts
Interpretation Act 1901.
Note 2: Section 40A and subsections (6) to (9) of this section deal with
variation of authorisations.
(5) A variation under subsection (3) or (4) takes effect on the day on
which the notice is given to the holder.
Variation of manufacturing site authorisations
(6) The holder of a licence may apply to the Secretary for a variation
of a manufacturing site authorisation in relation to the licence.
(7) An application under subsection (6) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) set out the variation sought; and
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(c) be delivered to an office of the Department specified in the
form; and
(d) be accompanied by the prescribed application fee.
(8) If an application is made under subsection (6) and any applicable
prescribed inspection fees have been paid, the Secretary may, by
notice in writing given to the holder of the licence, vary the
manufacturing site authorisation.
(9) A variation under subsection (8) takes effect on the day on which
the notice is given to the holder.
Removal of manufacturing sites
(9A) The holder of a licence may apply to the Secretary for a variation
of the licence so that it ceases to cover one or more manufacturing
sites specified in the application.
(9B) An application under subsection (9A) must:
(a) be made in accordance with a form approved by the
Secretary; and
(b) be delivered to an office of the Department specified in the
form; and
(c) be accompanied by the prescribed application fee.
(9C) If an application is made under subsection (9A), the Secretary may,
by notice in writing given to the holder of the licence, vary the
licence so that the licence does not cover each manufacturing site
specified in the notice.
(9D) A variation under subsection (9C) takes effect on the day specified
in the notice.
Further information
(10) The Secretary may, by notice in writing given to the holder of a
licence who has made an application under subsection (1), (6) or
(9A), require the holder:
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(a) to give to the Secretary, within such reasonable time as is
specified in the notice, such further information concerning
the application as is specified in the notice; or
(b) for an application under subsection (1) or (6)—to allow an
authorised person, at any reasonable time specified in the
notice, to inspect each manufacturing site identified in the
application and the equipment, processes and facilities that
will be used in the manufacture of therapeutic goods at that
site.
Applications or information may be given electronically
(11) An approval of a form mentioned in paragraph (2)(a), (7)(a) or
(9B)(a), or a notice mentioned in subsection (10), may require or
permit an application or information to be given in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41 Revocation and suspension of licences
(1) Subject to subsection (2), the Secretary may, by notice in writing
given to the holder of a licence, revoke the licence, or suspend the
licence for a period specified in the notice, if:
(a) at least one of the following persons:
(i) the holder;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the holder’s affairs;
(iii) if the holder is a body corporate—a major interest
holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
in that subparagraph applying occurred when the person
was a manager or major interest holder of the body
corporate; or
(d) the holder requests in writing that the licence be revoked or
suspended, as the case may be; or
(e) the holder ceases to carry on the business of manufacturing
the goods to which the licence relates; or
(ea) the holder contravenes a manufacturing site authorisation in
relation to the licence; or
(f) the annual licensing charge, or any applicable prescribed
inspection fees, have not been paid within 28 days after they
become payable; or
(g) the goods are exempt under section 18A and the holder has
breached a condition of the exemption in relation to those
goods; or
(ga) the licence covers a biological that is exempt under
section 32CB and the holder has breached a condition of the
exemption in relation to the biological; or
(h) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
(1A) A reference in paragraph (1)(a) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
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(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1B) Paragraph (1)(a) does not limit paragraph (1)(h).
(1C) In paragraph (1)(a):
manufacturing licence means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating
to therapeutic goods, relating to manufacturing therapeutic
goods.
(2) Where the Secretary proposes to revoke a licence or suspend a
licence otherwise than at the request of the holder of the licence,
the Secretary must, unless the Secretary considers that failure to
revoke or suspend the licence immediately would create an
imminent risk of death, serious illness or serious injury:
(a) by notice in writing given to the holder, inform the holder of
the action that the Secretary proposes to take and of the
reasons for that proposed action; and
(b) except where the proposed action is to be taken as a result of
a failure to pay the annual licensing charge or an applicable
prescribed inspection fee—give the holder an opportunity to
make, within such reasonable time as is specified in the
notice, submissions to the Secretary in relation to the
proposed action.
(3) Where the holder makes submissions in accordance with
paragraph (2)(b), the Secretary is not to make a decision relating to
the revocation or suspension of the licence before taking into
account the submissions.
(4) A licence may be revoked notwithstanding that the licence is
suspended.
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(5) Where a licence is suspended, the Secretary may, by notice in
writing given to the holder of the licence, revoke the suspension.
(6) Where the Secretary revokes or suspends a licence, the Secretary
must cause particulars of the decision to be published in the
Gazette or on the Department’s website as soon as is practicable
after the decision is made.
41AAAA Withdrawal of revocation of licence upon request
(1) If:
(a) the Secretary revokes a licence because of the request of a
person made under paragraph 41(1)(d); and
(b) before the end of the period of 90 days beginning on the day
the licence was revoked, the person requests, in writing, the
Secretary to withdraw the revocation; and
(c) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the person,
withdraw the revocation.
(2) If the revocation is withdrawn, the revocation is taken never to
have occurred.
41AA Spent convictions scheme
Nothing in section 40 or 41 affects the operation of Part VIIC of
the Crimes Act 1914 (which includes provisions that, in certain
circumstances, relieve persons from the requirement to disclose
spent convictions and require persons aware of such convictions to
disregard them).
41AB Secretary may require information or documents
(1) If:
(a) a person is the holder of a licence; and
(b) the person has carried out, or is carrying out, one or more
steps in the manufacture of therapeutic goods;
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the Secretary may, by written notice given to the person, require
the person to:
(c) give the Secretary information, or produce to the Secretary
documents, relating to one or more of the following:
(i) the therapeutic goods;
(ii) if the therapeutic goods consist of a mixture of
ingredients—those ingredients;
(iii) if the therapeutic goods consist of a mixture of
ingredients—the suppliers of those ingredients;
(iv) if the therapeutic goods consist of a combination of
component parts—those component parts;
(v) if the therapeutic goods consist of a combination of
component parts—the suppliers of those component
parts;
(vi) the containers or packages used, or proposed to be used,
to contain the therapeutic goods;
(vii) the batch numbers of the therapeutic goods;
(viii) the expiry dates of the therapeutic goods;
(ix) the distribution of the therapeutic goods;
(x) the conformity of the therapeutic goods to a standard
applicable to the goods;
(xi) the step or steps that the person has carried out, or is
carrying out, in the manufacture of the therapeutic
goods;
(xii) the premises used to carry out one or more steps in the
manufacture of the therapeutic goods;
(xiii) the observance of the manufacturing principles;
(xiv) the names, qualifications and experience of individuals
who have control of any of the steps that have been
carried out, or are being carried out, in the manufacture
of the therapeutic goods;
(xv) the measures for quality assurance and quality control
employed in the taking of any of the steps that have
been carried out, or are being carried out, in the
manufacture of the therapeutic goods;
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(xvi) compliance with the conditions of the licence;
(xvii) whether there are grounds for revoking or suspending
the licence;
(xviii) any other matter that is prescribed by the regulations
and that relates to the manufacture of the therapeutic
goods; and
(d) do so:
(i) within such reasonable time as is specified in the notice;
and
(ii) in such form as is specified in the notice.
(2) The time specified in the notice must not be shorter than 14 days
after the notice is given.
(3) The rule in subsection (2) does not apply if the Secretary is
satisfied that, because of circumstances of urgency, the time
specified in the notice should be shorter than 14 days after the
notice is given.
(4) An approval of a form may require or permit the information to be
given, or the documents to be produced, in accordance with
specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
41AC Criminal offence for contravening a requirement in a notice
under section 41AB
A person commits an offence if:
(a) the person has been given a notice under section 41AB; and
(b) the person omits to do an act; and
(c) the omission contravenes a requirement in the notice.
Penalty: 400 penalty units.
41AD False or misleading information—offence
(1) A person commits an offence if:
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(a) the person is given a notice under section 41AB; and
(b) the person gives information to the Secretary in compliance,
or purported compliance, with the notice; and
(c) the person does so knowing that the information:
(i) is false or misleading; or
(ii) omits any matter or thing without which the information
is misleading.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(2) Subsection (1) does not apply as a result of subparagraph (1)(c)(i)
if the information is not false or misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2).
(3) Subsection (1) does not apply as a result of subparagraph (1)(c)(ii)
if the information did not omit any matter or thing without which
the information is misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3).
41AE False or misleading documents—offence
(1) A person commits an offence if:
(a) the person produces a document to the Secretary; and
(b) the person does so knowing that the document is false or
misleading; and
(c) the document is produced in compliance, or purported
compliance, with a notice given under section 41AB.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(2) Subsection (1) does not apply if the document is not false or
misleading in a material particular.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (2).
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(3) Subsection (1) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
Note: A defendant bears an evidential burden in relation to the matter in
subsection (3).
41AF False or misleading information or documents—civil penalty
(1) A person contravenes this section if:
(a) the person is given a notice under section 41AB; and
(b) the person gives information, or produces a document, in
compliance or purported compliance with the notice; and
(c) the information or document is false or misleading in a
material particular.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
(2) Subsection (1) does not apply to a person who produces a
document if the document is accompanied by a written statement
signed by the person or, in the case of a body corporate, by a
competent officer of the body corporate:
(a) stating that the document is, to the knowledge of the
first-mentioned person, false or misleading in a material
particular; and
(b) setting out, or referring to, the material particular in which
the document is, to the knowledge of the first-mentioned
person, false or misleading.
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41AG Self-incrimination
(1) A person is not excused from giving information or a producing a
document under a section 41AB notice on the ground that the
giving of the information or the production of the document would
tend to incriminate the person or expose the person to a penalty.
(2) However, in the case of an individual:
(a) the information given or the document produced; or
(b) the giving of the information or the production of the
document; or
(c) any information, document or thing obtained as a direct or
indirect consequence of giving the information or producing
the document;
is not admissible in evidence in:
(d) criminal proceedings against the individual, except
proceedings under, or arising out of, section 41AD or 41AE;
or
(e) proceedings for a pecuniary penalty order against the
individual for a contravention of a civil penalty provision.
41AAA Transfer of licences
(1) The regulations may make provision for and in relation to the
transfer of licences.
(2) Regulations made for the purposes of subsection (1) may make
provision for and in relation to:
(a) the making of an application for the transfer of a licence; and
(b) the payment of a fee in respect of an application; and
(c) the assessment of an application; and
(d) the conditions of a licence upon the transfer of the licence;
and
(e) the review of decisions made under the regulations.
(3) Subsection (2) does not limit subsection (1).
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41A Publication of list of manufacturers etc.
The Secretary may, from time to time and in such manner as the
Secretary determines, publish a list of the persons who are licensed
under this Part, the classes of goods to which the licences relate,
the steps of manufacture that the licences authorise and the
addresses of the manufacturing sites to which the licences relate.
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Part 4-1 Introduction
Division 1 Overview of this Chapter
Section 41B
Chapter 4—Medical devices Note: This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that
are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.
Part 4-1—Introduction
Division 1—Overview of this Chapter
41B General
The purpose of this Chapter is to ensure the safety and satisfactory
performance of medical devices. It does this by:
(a) setting out particular requirements for medical devices; and
(b) establishing administrative processes principally aimed at
ensuring those requirements are met; and
(c) providing for enforcement through a series of offences and
civil penalty provisions.
41BA Requirements for medical devices (Parts 4-2 and 4-3)
The requirements for medical devices are:
(a) essential principles (that are about the safety and
performance characteristics of medical devices); and
(b) conformity assessment procedures (that are mainly about the
application of quality management systems) or requirements
comparable to conformity assessment procedures.
Note: Medical device standards may be made under Division 2 of Part 4-2,
and conformity assessment standards may be made under Division 2
of Part 4-3, but they are not requirements.
41BB Administrative processes (Parts 4-4 to 4-10)
The administrative processes under this Chapter are:
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(a) issuing conformity assessment certificates for some
manufacturers of medical devices; and
(aa) making conformity assessment body determinations; and
(b) including medical devices in the Register; and
(c) suspending or cancelling entries of medical devices from the
Register; and
(ca) exempting medical devices from various provisions of this
Chapter to deal with emergency situations; and
(d) exempting medical devices from the requirement to be
included in the Register; and
(e) obtaining information about medical devices; and
(f) requiring public notification of problems with medical
devices, and recall of such devices.
Note: Part 4-10 provides for assessment fees to be payable in some
circumstances.
41BC Enforcement (Part 4-11)
Part 4-11 contains offences and civil penalty provisions that are
aimed at ensuring that:
(a) the requirements for medical devices are complied with; and
(b) the administrative processes under this Chapter (particularly
the inclusion of medical devices in the Register) are
followed.
Note: There are some offences and civil penalty provisions in Parts 4-4 to
4-9. They generally relate to matters ancillary to administrative
processes in those Parts (e.g. false or misleading statements in
applications).
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Part 4-1 Introduction
Division 2 Interpretation
Section 41BD
Division 2—Interpretation
41BD What is a medical device
(1) A medical device is:
(a) any instrument, apparatus, appliance, material or other article
(whether used alone or in combination, and including the
software necessary for its proper application) intended, by
the person under whose name it is or is to be supplied, to be
used for human beings for the purpose of one or more of the
following:
(i) diagnosis, prevention, monitoring, treatment or
alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or disability;
(iii) investigation, replacement or modification of the
anatomy or of a physiological process;
(iv) control of conception;
and that does not achieve its principal intended action in or
on the human body by pharmacological, immunological or
metabolic means, but that may be assisted in its function by
such means; or
(aa) any instrument, apparatus, appliance, material or other article
specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, material or other article
that is included in a class of instruments, apparatus,
appliances, materials or other articles specified under
subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, material
or other article covered by paragraph (a), (aa) or (ab).
Note: Declarations under subsection (3) exclude articles from the scope of
this definition. Declarations under section 7 can also have this effect:
see subsection 7(4).
(2) For the purposes of paragraph (1)(a), the purpose for which an
instrument, apparatus, appliance, material or other article (the main
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equipment) is to be used is to be ascertained from the information
supplied, by the person under whose name the main equipment is
or is to be supplied, on or in any one or more of the following:
(a) the labelling on the main equipment;
(b) the instructions for using the main equipment;
(c) any advertising material relating to the main equipment;
(d) technical documentation describing the mechanism of action
of the main equipment.
(2A) The Secretary may, by notice published in the Gazette or on the
Department’s website, specify a particular instrument, apparatus,
appliance, material or other article for the purposes of
paragraph (1)(aa). The notice is not a legislative instrument.
(2B) The Secretary may, by legislative instrument, specify a particular
class of instruments, apparatus, appliances, materials or other
articles for the purposes of paragraph (1)(ab).
(3) The Secretary may, by order published in the Gazette or on the
Department’s website, declare that a particular instrument,
apparatus, appliance, material or other article, or that a particular
class of instruments, apparatus, appliances, materials or other
articles, are not, for the purposes of this Act, medical devices.
Note: A declaration under this section does not stop articles from being
therapeutic goods.
(4) A declaration under this section takes effect on the day on which
the declaration is published in the Gazette or on the Department’s
website or on such later day as is specified in the order.
41BE Kinds of medical devices
General
(1) For the purposes of this Chapter, a medical device is taken to be of
the same kind as another medical device if they:
(a) have the same sponsor; and
(b) have the same manufacturer; and
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(c) have the same device nomenclature system code (see
subsection (3)); and
(d) have the same medical device classification; and
(e) are the same in relation to such other characteristics as the
regulations prescribe, either generally or in relation to
medical devices of the kind in question.
Unique medical devices
(2) If a medical device is not of the same kind as any other medical
device:
(a) this Chapter applies in relation to the device as if it were a
kind of medical device; and
(b) references in this Chapter to delivering a reasonable number
of samples of the kind of device are taken to be references to
delivering the device.
Device nomenclature codes
(3) The Minister may, by legislative instrument, determine device
nomenclature codes for medical devices.
41BEA Excluded purposes
The Secretary may, by legislative instrument, specify purposes for
the purposes of paragraph 41FD(ia) and subsection 41FF(1A).
41BF System or procedure packs
(1) A package and therapeutic goods in the package are a system or
procedure pack if:
(a) the package and the therapeutic goods are for use as a unit,
either in combination as a system or in a medical or surgical
procedure; and
(b) the package contains at least one medical device; and
(c) the package and the therapeutic goods do not constitute a
composite pack.
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(2) To avoid doubt, a system or procedure pack is a medical device.
41BG Manufacturers of medical devices
(1) The manufacturer of a medical device is the person who is
responsible for the design, production, packaging and labelling of
the device before it is supplied under the person’s name, whether
or not it is the person, or another person acting on the person’s
behalf, who carries out those operations.
(2) If subsection (1) does not apply to a medical device, the
manufacturer of the device is the person who, with a view to
supplying the device under the person’s name, does one or more of
the following using ready-made products:
(a) assembles the device;
(b) packages the device;
(c) processes the device;
(d) fully refurbishes the device;
(e) labels the device;
(f) assigns to the device its purpose by means of information
supplied, by the person, on or in any one or more of the
following:
(i) the labelling on the device;
(ii) the instructions for using the device;
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of
action of the device.
(3) However, a person is not the manufacturer of a medical device if:
(a) the person assembles or adapts the device for an individual
patient; and
(b) the device has already been supplied by another person; and
(c) the assembly or adaptation does not change the purpose
intended for the device by means of information supplied by
that other person, on or in any one or more of the following:
(i) the labelling on the device;
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Section 41BH
(ii) the instructions for using the device;
(iii) any advertising material relating to the device;
(iv) technical documentation describing the mechanism of
action of the device.
(4) A person is not the manufacturer of a medical device if the person
is included in a class of persons prescribed by the regulations for
the purposes of this subsection.
41BH Meaning of compliance with essential principles
(1) A medical device complies, for the purposes of this Chapter
(including Part 4-11), with the essential principles if and only if it
does not contravene any of the essential principles.
(2) However, a medical device is also taken, for the purposes of this
Chapter (other than Part 4-11), to comply with the essential
principles if:
(a) the medical device complies with one or more medical device
standards that apply to it; and
(b) the medical device contravenes the essential principles only
in respect of a part or parts of the essential principles to
which that medical device standard, or one or more of those
medical device standards, relate.
(3) For the purposes of this section, a medical device standard relates
to a part or parts of the essential principles only if the standard
specifies that part or parts.
41BI Meaning of non-application of conformity assessment
procedures
(1) A conformity assessment procedure is taken, for the purposes of
this Chapter, not to have been applied to a medical device if:
(a) there has been a contravention of the conformity assessment
procedures; and
(b) the contravention relates, wholly or partly, to that device or
its manufacture.
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(2) However, for the purposes of this Chapter (other than Part 4-11),
subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of
the medical device complies with one or more conformity
assessment standards that apply to it; and
(b) the contravention is only in respect of a part or parts of the
conformity assessment procedures to which that conformity
assessment standard, or one or more of those conformity
assessment standards, relate.
(3) For the purposes of this section, a conformity assessment standard
relates to a part or parts of the conformity assessment procedures
only if the standard specifies that part or parts.
41BIA Meaning of non-application of overseas requirements
comparable to conformity assessment procedures
(1) A requirement that is comparable to a conformity assessment
procedure is taken, for the purposes of this Chapter, not to have
been applied to a medical device by the manufacturer of the device
if:
(a) there has been a contravention of the requirement; and
(b) the contravention relates, wholly or partly, to that device or
its manufacture.
(2) However, for the purposes of this Chapter (other than Part 4-11),
subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of
the medical device complies with one or more conformity
assessment standards that apply to it; and
(b) the contravention is only in respect of a part or parts of the
requirement to which that conformity assessment standard, or
one or more of those conformity assessment standards, relate.
41BIB Overseas regulators
(1) An overseas regulator is a body determined in an instrument under
subsection (2).
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Section 41BIB
(2) The Secretary may, by notifiable instrument, determine a body for
the purposes of subsection (1). The Secretary must be satisfied that
the body:
(a) is established outside Australia; and
(b) is empowered to issue certificates or other documents to the
effect that the body is satisfied that requirements, comparable
to the conformity assessment procedures, have been applied
to medical devices by the manufacturers of the devices.
(3) Without limiting subsection (2), the Secretary may determine a
body by reference to a designation, recognition, approval or
authorisation (however described) of the body:
(a) by one or more countries; or
(b) by another body.
Note: For specification by class, see subsection 13(3) of the Legislation Act
2003.
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Section 41BJ
Division 3—Application provisions
41BJ Application of this Chapter to medical devices covered by
Part 3-2
(1) This Chapter does not apply to a medical device if section 15A
applies to the device, except for purposes connected with:
(a) applications for including the medical device in the Register
under this Chapter; or
(b) including the medical device in the Register under this
Chapter.
Note: Section 15A sets out the circumstances in which Part 3-2 applies or
continues to apply to medical devices.
(2) However, if an exemption under section 34 applied to a medical
device, or the manufacturer of the device, immediately before the
commencement of this Chapter:
(a) Parts 4-3 and 4-4, and Division 2 of Part 4-11, apply in
relation to the device after the end of the period of 2 years
after that commencement; and
(b) Parts 4-8, 4-9 and 4-10, and Divisions 3 and 4 of Part 4-11,
apply in relation to the device, to the extent that they relate to
any of the provisions referred to in paragraph (a), after the
end of that period.
41BJA Application of this Chapter to a biological
(1) Subject to this section, this Chapter does not apply to a biological
on and after the commencement of this section.
Biologicals currently included in the Register
(2) If, immediately before the commencement of this section,
therapeutic goods that are a biological were included in the
Register under this Chapter, this Chapter continues to apply to the
biological on and after that commencement until the time the
biological is included in the Register under Part 3-2A.
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Section 41BJA
Note: Section 32DN deals with including the biological under Part 3-2A.
Pending applications
(3) If:
(a) before the commencement of this section, an application was
made under this Chapter for the inclusion in the Register of
therapeutic goods that are a biological; and
(b) immediately before that commencement, the application was
not finally determined; and
(c) the application had not been withdrawn before that
commencement;
this Chapter continues to apply to the biological on and after that
commencement until the earliest of the following:
(d) the time the biological is included in the Register under
Part 3-2A;
(e) if the application is unsuccessful when it is finally
determined—the time the application is finally determined;
(f) the time the application is withdrawn;
(g) the time the application lapses.
Note: Section 32DN deals with including the biological under Part 3-2A.
(4) For the purposes of this section, an application is finally
determined when the application, and any applications for review
or appeals arising out of it, have been finally determined or
otherwise disposed of.
Transitional
(5) This Chapter applies to a biological on and after the
commencement of this section in relation to things done, or
omitted to be done, in relation to the biological before the
commencement of this section.
(6) If this Chapter continues to apply to a biological during a period
described in subsection (2) or (3), then this Chapter also applies to
the biological after the end of that period in relation to things done,
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Section 41BK
or omitted to be done, in relation to the biological during that
period.
41BK Application of the Criminal Code
Chapter 2 of the Criminal Code applies to all offences against this
Chapter.
Note: Chapter 2 of the Criminal Code sets out the general principles of
criminal responsibility.
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Part 4-2 Essential principles and medical device standards
Section 41C
Part 4-2—Essential principles and medical device
standards
41C What this Part is about
The essential principles set out the requirements relating to the
safety and performance characteristics of medical devices.
Compliance with applicable medical device standards is not
required, but it is one way to establish compliance with essential
principles.
Note: Dealing in medical devices that do not comply with the essential
principles may be an offence or may contravene a civil penalty
provision: see Division 1 of Part 4-11.
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Essential principles Division 1
Section 41CA
Division 1—Essential principles
41CA Essential principles
(1) The regulations may set out requirements for medical devices.
(2) These requirements are to be known as the essential principles.
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Part 4-2 Essential principles and medical device standards
Division 2 Medical device standards
Section 41CB
Division 2—Medical device standards
41CB Medical device standards
(1) The Minister may, by legislative instrument, make an order
determining that:
(a) matters specified in the order constitute a medical device
standard for kinds of medical devices identified in the order;
and
(b) medical devices of those kinds that comply with the standard
are to be treated as complying with those parts of the
essential principles specified in the standard.
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
41CC Content of medical device standards
(1) Without limiting the scope of section 41CB, an order establishing a
medical device standard for kinds of medical devices may be
specified by reference to:
(a) the safety or performance characteristics of the devices; or
(b) a monograph in the British Pharmacopoeia, the European
Pharmacopoeia or the United States Pharmacopeia-National
Formulary; or
(c) a monograph in a publication approved by the Minister for
the purposes of this subsection; or
(d) such a monograph as modified in a manner specified in the
order; or
(e) a standard published by a standards organisation; or
(f) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(e), these are standards
organisations:
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Section 41CD
(a) Standards Australia;
(b) the International Organisation for Standardization;
(c) the International Electrotechnical Commission;
(d) the European Committee for Standardization;
(e) the European Committee for Electrotechnical
Standardization;
(f) any other organisation declared by the Minister by notice
published in the Gazette or on the Department’s website.
41CD Inconsistencies between medical device standards
(1) A medical device standard that:
(a) applies to a kind of medical device; and
(b) is inconsistent with another medical device standard that
applies only to some of the devices of that kind;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
(2) A medical device standard that applies to a kind of medical device
that consists of a combination of component parts takes precedence
over any medical device standard that applies to the component
parts.
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Part 4-3 Conformity assessment procedures
Section 41D
Part 4-3—Conformity assessment procedures
41D What this Part is about
The conformity assessment procedures set out the requirements
relating to the application of quality management systems for
medical devices, and other requirements imposed on
manufacturers.
Compliance with applicable conformity assessment standards is
not required, but it is one way to establish that one or more parts of
the conformity assessment procedures have been applied to
medical devices.
Note 1: Dealing in medical devices that have not had the conformity
assessment procedures applied may be an offence or may contravene a
civil penalty provision: see Division 2 of Part 4-11.
Note 2: See section 41BI on applying the conformity assessment procedures.
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Section 41DA
Division 1—Conformity assessment procedures
41DA Conformity assessment procedures
(1) The regulations may set out requirements relating to the
obligations of manufacturers of medical devices.
(2) These requirements are to be known as the conformity assessment
procedures.
(3) The conformity assessment procedures, or any part of the
conformity assessment procedures, may:
(a) be limited in their application to one or more medical device
classifications; or
(b) apply differently to different medical device classifications,
different kinds of medical devices or different manufacturers.
(4) Without limiting subsection (1), the regulations may relate to all or
any of the following:
(a) application of quality management systems for the
manufacture of medical devices;
(b) certification of compliance with the essential principles, or
the quality management systems for the manufacture of
medical devices;
(c) notification of, and assessment of, changes to a
manufacturer’s product range, product design or quality
management systems;
(d) declarations to be made by manufacturers of medical devices
that conformity assessment procedures have been applied to
the devices;
(e) marks to be affixed to medical devices indicating the
application of the conformity assessment procedures to the
devices;
(f) monitoring and inspecting the design of medical devices or
the manufacturing processes for medical devices;
(g) monitoring the performance of medical devices;
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Section 41DB
(h) corrective action required in relation to the design,
manufacture, packaging, labelling and supply of medical
devices;
(i) keeping records of the manufacture of medical devices, the
design of medical devices or the manufacturing processes for
medical devices.
41DB Medical device classifications
The regulations may specify:
(a) classifications, to be known as medical device
classifications, applying to medical devices or kinds of
medical devices; and
(b) matters in relation to the classification of medical devices or
kinds of medical devices.
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Conformity assessment standards Division 2
Section 41DC
Division 2—Conformity assessment standards
41DC Conformity assessment standards
(1) The Minister may, by legislative instrument, make an order
determining that:
(a) matters specified in the order constitute a conformity
assessment standard for quality management systems
identified in the order; and
(b) a quality management system that complies with the standard
is to be treated as having had applied to it those parts of the
conformity assessment procedures specified in the standard.
Note: Section 12 of the Legislation Act 2003 deals with when a legislative
instrument commences.
(2) A conformity assessment standard may be limited to particular
kinds of medical devices.
(3) The Minister may, by legislative instrument, vary or revoke an
order made under subsection (1).
41DD Content of conformity assessment standards
(1) Without limiting the scope of section 41DC, an order establishing a
conformity assessment standard for a kind of medical device may
be specified by reference to:
(a) procedures to be carried out under the quality management
systems for the design, manufacture and final inspection of
the devices; or
(b) a standard published by a standards organisation; or
(c) such other matters as the Minister thinks fit.
(2) For the purposes of paragraph (1)(b), these are standards
organisations:
(a) Standards Australia;
(b) the International Organisation for Standardization;
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Section 41DE
(c) the European Committee for Standardization;
(d) any other organisation declared by the Minister by notice
published in the Gazette or on the Department’s website.
41DE Inconsistencies between conformity assessment standards
A conformity assessment standard that:
(a) identifies quality management systems to which it applies;
and
(b) is inconsistent with another conformity assessment standard
that applies only to particular kinds of medical devices;
is, to the extent of the inconsistency, of no effect in relation to the
devices referred to in paragraph (b).
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Section 41E
Part 4-4—Conformity assessment certificates
41E What this Part is about
The Secretary can issue a conformity assessment certificate (which
may be limited to some medical devices) in respect of a
manufacturer of medical devices, signifying one or more of these:
(a) that relevant quality management systems have
been applied to the device;
(b) the essential principles for the device have been
complied with;
(c) other certification requirements of the conformity
assessment procedures have been met.
Note: A conformity assessment certificate may be required for an
application to include a kind of medical device in the Register to pass
preliminary assessment: see paragraph 41FDB(2)(e).
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Division 1 Issuing conformity assessment certificates
Section 41EA
Division 1—Issuing conformity assessment certificates
41EA When conformity assessment certificates are required
The regulations may prescribe:
(a) kinds of manufacturers in respect of whom a conformity
assessment certificate must be issued before valid
applications can be made for kinds of medical devices,
manufactured by those manufacturers, to be included in the
Register; or
(b) kinds of medical devices in respect of which a conformity
assessment certificate must be issued before valid
applications can be made for those kinds of medical devices
to be included in the Register.
Note: The regulations may prescribe different levels of fees for different
kinds of manufacturers and medical devices: see subsection 41LA(2).
41EB Applications
(1) An application for a conformity assessment certificate must:
(a) be made in accordance with a form approved, in writing, by
the Secretary or in such other manner as is approved, in
writing, by the Secretary; and
(b) be delivered to an office of the Department specified by the
Secretary.
Note: A conformity assessment fee is payable under section 41LA for
consideration of the application.
(2) An application is not effective if:
(a) the prescribed application fee has not been paid; or
(b) the application contains information that is false or
misleading in a material particular.
Note: A person might also commit an offence, or contravene a civil penalty
provision, if the person makes a statement in an application that is
false or misleading in a material particular: see sections 41EI and
41EIA.
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Section 41EC
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) The Secretary may, by written notice given to an applicant for a
conformity assessment certificate, require the applicant to allow an
authorised person, at any reasonable time specified in the notice, to
inspect:
(a) the premises (including premises outside Australia) and
equipment, processes and facilities that are being or will be
used to manufacture medical devices of the kind in question;
and
(b) any other kinds of medical devices on those premises.
41EC Considering applications
(1) If the application is made in accordance with section 41EB, the
Secretary must decide whether to issue the conformity assessment
certificate.
(2) In deciding whether to issue the certificate, the Secretary must
consider some or all aspects of whether the conformity assessment
procedures relating to one or more of the following have been
applied to the medical device:
(a) the application of quality management systems for the
manufacture of medical devices;
(b) the certification of compliance with the essential principles;
(c) any other requirement of the conformity assessment
procedures specified in regulations made for the purposes of
this subsection.
(3) In deciding whether to issue the certificate, the Secretary must also
consider:
(a) whether at least one of the following persons:
(i) the applicant;
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Section 41EC
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the applicant’s affairs;
(iii) if the applicant is a body corporate—a major interest
holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment
document; or
(ix) had a conformity assessment document suspended or
revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies in that 10 year period, if
the conduct resulting in that subparagraph applying
occurred when the person was a manager or major
interest holder of the body corporate; or
(b) whether any other circumstances prescribed by the
regulations for the purposes of this paragraph exist.
(4) A reference in paragraph (3)(a) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
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Section 41ECA
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(5) Paragraph (3)(a) does not limit paragraph (3)(b).
(6) The Secretary may, by written notice given to the applicant, require
the applicant:
(a) to deliver to the office to which the application was made a
reasonable number of samples of the kind of medical device
to which the application relates within the period, of not less
than 14 days after the day the notice is given, specified in the
notice; and
(b) to do so in a manner specified in the notice.
41ECA Conformity assessment (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make conformity assessment (priority
applicant) determinations.
(2) A conformity assessment (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 41EB application
that may be made by the person for a conformity assessment
certificate in relation to medical devices of a kind specified in the
determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for conformity assessment (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
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Section 41ECA
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a conformity assessment
(priority applicant) determination;
(b) the consequences of the revocation of a conformity
assessment (priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
(6) The regulations may make provision for and in relation to the
priority to be given by the Secretary to consideration of a
section 41EB application where the applicant is a priority
applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 41EB
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a conformity assessment (priority applicant) determination is in
force under the regulations, the determination may be published on
the Department’s website.
(10) A conformity assessment (priority applicant) determination made
under the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a conformity assessment
(priority applicant) determination.
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Section 41ED
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
41ED Time for making decisions on applications
If the application relates to the issuing of a conformity assessment
certificate in relation to which a period has been prescribed under
paragraph 63(2)(dc), a decision on the application must be made
within that period, unless the application lapses under
section 41EG.
41EE Procedure following making a decision whether to issue
certificate
(1) After making a decision whether to issue a conformity assessment
certificate, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days; and
(b) if the decision is not to issue the certificate—state in the
notice the reasons for the decision; and
(c) if the decision is to issue the certificate and all assessment
fees that are due and payable for the application have been
paid:
(i) issue the certificate to the manufacturer in relation to
whom the application was made; and
(ii) give the applicant a copy of the certificate (if the
applicant is not the manufacturer).
(2) A conformity assessment certificate must specify whether it
covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the
manufacturer.
(3) A conformity assessment certificate must contain any other
information prescribed by the regulations for the purposes of this
subsection.
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Section 41EF
41EF Duration of certificate
(1) The conformity assessment certificate commences on the day
specified for the purpose in the certificate. The certificate must
specify the period for which it is to be in force (which must be no
longer than 5 years).
(2) A conformity assessment certificate has effect at all times:
(a) unless the certificate is suspended under Division 3; or
(b) until the end of the period specified in the certificate, or if the
Secretary extends that period, until the end of that extended
period; or
(c) until the certificate is revoked under Division 4.
Extensions
(3) The Secretary may, in writing and on his or her own initiative,
extend the period for which a conformity assessment certificate is
in force.
(4) An extension must be no longer than 12 months.
(5) Only one extension may be given.
(6) The Secretary:
(a) must give notice of an extension to the manufacturer in
relation to whom the certificate was issued; and
(b) may give notice of an extension to the applicant for the
certificate (if the applicant is not the manufacturer).
41EG Lapsing of applications
An application for a conformity assessment certificate lapses if:
(a) the applicant does not deliver to the office to which the
application was made such information (in a form approved
in writing by the Secretary) as will allow the certificate to be
issued; or
(b) the applicant does not comply with a requirement by the
Secretary under subsection 41EC(6) to deliver to the office to
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Section 41EH
which the application was made a reasonable number of
samples of the kind of medical device to which the
application relates; or
(c) the applicant fails to comply with a notice under
section 41JA to give to the Secretary information within a
further 10 working days from the day specified in the notice;
or
(d) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a notice under
section 41JA, is false or misleading in a material particular;
or
(e) the applicant fails to allow an authorised person to carry out
any inspection as required under subsection 41EB(4); or
(f) for the whole or a part of the conformity assessment fee for
the application that is due and payable in accordance with
regulations made for the purposes of Part 4-10—the applicant
fails to pay that whole or part in accordance with those
regulations.
41EH Treating applications as having been refused
(1) The applicant for an application for a conformity assessment
certificate may give the Secretary written notice that the applicant
wishes to treat the application as having been refused if:
(a) a period is prescribed under paragraph 63(2)(dc) for making a
decision on the application; and
(b) at the end of the period, the applicant has not been notified of
a decision whether to issue the certificate.
(2) The notice may be given at any time before the applicant is notified
of the decision.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to issue the certificate; and
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Section 41EI
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary.
41EI Criminal offences for making a false statement
(1) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is made in or in connection with an application
for a conformity assessment certificate; and
(c) the person knows that the statement is false or misleading in
a material particular; and
(d) either:
(i) the use of the kind of medical device has resulted in,
will result in, or is likely to result in, harm or injury to
any person; or
(ii) the use of the kind of medical device, if the kind of
medical device were used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is in or in connection with an application for a
conformity assessment certificate; and
(c) the person knows that the statement is false or misleading in
a material particular.
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Section 41EIA
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is in or in connection with an application for a
conformity assessment certificate; and
(c) the statement is false or misleading in a material particular.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
41EIA Civil penalty for making a false statement
A person contravenes this section if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with an application for a
conformity assessment certificate.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
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Section 41EJ
Division 2—Conditions
Note: Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (8) and (8A)), and may contravene a civil penalty provision (see subsection 41MNA(2)).
41EJ Automatic conditions on conformity assessment certificates
Entry and inspection powers
(1) A conformity assessment certificate is subject to the conditions that
the manufacturer in respect of whom the certificate is issued will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, premises (including
premises outside Australia) at which the person or any
other person deals with medical devices of a kind
covered by the certificate; and
(ii) while on those premises, to inspect those premises and
medical devices of any kind on those premises and to
examine, take measurements of, conduct tests on,
require tests to be conducted on or take samples of
medical devices of any kind on those premises or any
thing on those premises that relates to medical devices
of any kind; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(b) if requested to do so by an authorised person:
(i) produce to the person such documents relating to
devices of a kind covered by the certificate, or to the
manufacturer’s quality management system, as the
person requires; and
(ii) allow the person to copy the documents.
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Section 41EJ
Review
(2) A conformity assessment certificate is subject to the condition that
the manufacturer in respect of whom the certificate is issued will
cooperate in any review by the Secretary of the certificate to
determine whether the conformity assessment procedures relating
to the following matters have been applied to the kinds of medical
devices covered by the certificate:
(a) the application of quality management systems for the
manufacture of medical devices;
(b) the certification of compliance with the essential principles;
(c) any other requirement of the conformity assessment
procedures specified in the regulations made for the purposes
of subsection 41EC(2).
Notification of substantial changes
(3) A conformity assessment certificate is subject to the condition that
the person in respect of whom the certificate is issued will notify
the Secretary, in writing, of any plan for substantial changes to:
(a) quality management systems; or
(b) the product range covered by those systems; or
(c) the product design of kinds of medical devices;
in respect of which the certificate is issued.
Fees
(4) A conformity assessment certificate is subject to the condition that
the applicant for the certificate will pay a fee, prescribed in the
regulations, for a review under subsection (2), when the fee
becomes due and payable.
(5) The regulations may prescribe different levels of fees for different
kinds of manufacturers and medical devices.
Conditions in regulations
(5A) A conformity assessment certificate is subject to any conditions
prescribed by the regulations for the purposes of this subsection.
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Section 41EK
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
41EK Conditions imposed when conformity assessment certificates
are issued
If the Secretary issues a conformity assessment certificate in
respect of a manufacturer, the Secretary may, in writing, impose
conditions on the certificate in respect of:
(a) one or more kinds of medical devices covered by the
certificate; or
(b) the manufacturer’s quality management system.
41EL Conditions imposed after issuing a conformity assessment
certificate
(1) The Secretary may, by written notice given to a manufacturer in
respect of whom a conformity assessment certificate has been
issued:
(a) impose new conditions on the certificate in respect of:
(i) one or more kinds of medical devices covered by the
certificate; or
(ii) the manufacturer’s quality management system; or
(b) vary or remove existing conditions.
The power may be exercised at the request of the applicant for the
certificate or on the Secretary’s own initiative.
(2) The imposition, variation or removal of a condition under this
section takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 20 working
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Section 41EL
days after the notice is given to the person, unless the person
has agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 20 working days after the notice is given to the person,
unless the person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(3) For the purposes of paragraphs (2)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
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Division 3 Suspension of conformity assessment certificates
Section 41EM
Division 3—Suspension of conformity assessment
certificates
41EM Suspension of conformity assessment certificates
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, suspend the
certificate if the Secretary is satisfied that it is likely that there are
grounds for revoking the certificate under section 41ET.
(2) The suspension may be limited to some medical devices of that
kind, as specified in the notice.
(3) The notice must specify the period of the suspension. The period
must not exceed 6 months.
Note: The period of the suspension may be extended under section 41EO.
41EN Notice of proposed suspension
(1) However, before suspending a conformity assessment certificate,
the Secretary must:
(a) inform the person in writing that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (1)(b).
(3) This section does not apply if the notice under section 41EM states
that the suspension is necessary to prevent imminent risk of death,
serious illness or serious injury.
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Section 41EO
41EO Duration of suspension
(1) The suspension takes effect:
(a) if the notice under section 41EM states that the suspension is
necessary to prevent imminent risk of death, serious illness or
serious injury—on the day on which the notice is given to the
person; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41EP; or
(b) the expiry of:
(i) the period specified in the notice under section 41EM;
or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Note: Unless a suspension of a conformity assessment certificate has been
revoked, the certificate is automatically revoked: see section 41ER.
(3) If a person in relation to whom a kind of medical device is
included in the Register shows that he or she has taken steps to
address the grounds for revoking the certificate under
section 41ET, the Secretary may, by written notice given to the
person, extend the period specified in the notice under
section 41EM by a further specified period not exceeding 6
months.
41EP Revocation of suspension
(1) The Secretary must revoke the suspension if the Secretary is
satisfied that:
(a) the ground on which the conformity assessment certificate
was suspended no longer applies; and
(b) there are no other grounds for suspending the certificate.
(2) The Secretary’s power to revoke the suspension may be exercised:
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Section 41EQ
(a) if:
(i) the manufacturer in relation to whom the conformity
assessment certificate was issued; or
(ii) the person who applied for the certificate (if the
applicant was not the manufacturer);
applies in writing to the Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must, within 20
working days after the revocation, give written notice of the
revocation to the person in relation to whom the conformity
assessment certificate was issued.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
41EQ Powers of revocation of conformity assessment certificates
unaffected
(1) This Division does not affect the Secretary’s powers to revoke a
conformity assessment certificate under Division 4.
(2) To the extent that a suspension under this Division relates to a
conformity assessment certificate to which such a revocation
relates, the suspension ceases to have effect.
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Section 41ER
Division 4—Revocation of conformity assessment
certificates
41ER Automatic revocation of conformity assessment certificates
The Secretary must, by written notice given to the person in
relation to whom a conformity assessment certificate is issued,
revoke the certificate if:
(a) the certificate has been suspended under section 41EM; and
(b) the period applying to the suspension under
subsection 41EM(3) or 41EO(3) (as the case requires)
expires before the suspension is revoked under section 41EP.
41ES Immediate revocation of conformity assessment certificates
(1) The Secretary may, by written notice given to the manufacturer in
relation to whom a conformity assessment certificate is issued,
revoke the certificate if the manufacturer requests in writing the
revocation of the certificate.
(2) If:
(a) the Secretary revokes a certificate under subsection (1); and
(b) before the end of the period of 90 days beginning on the day
the certificate was revoked, the manufacturer requests, in
writing, the Secretary to withdraw the revocation; and
(c) the request is accompanied by the prescribed application fee
(if any);
the Secretary may, by notice in writing given to the manufacturer,
withdraw the revocation.
(3) If the revocation is withdrawn, the revocation is taken never to
have occurred.
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Division 4 Revocation of conformity assessment certificates
Section 41ET
41ET Revocation of conformity assessment certificates after notice
of proposed revocation
(1) The Secretary may, by written notice given to the person in relation
to whom a conformity assessment certificate is issued, revoke the
certificate if:
(a) the conformity assessment procedures have not been applied
to medical devices of a kind to which the certificate applies;
or
(b) the manufacturer in relation to whom the certificate is issued
refuses or fails to comply with a condition to which the
certificate is subject; or
(c) the Secretary gives to the person a notice under section 41JA
that requires the person to give to the Secretary information
or documents and the person fails to comply with that notice
within a further 10 working days from the day specified in
that notice; or
(d) the manufacturer in respect of whom the certificate is issued
no longer manufactures any of the kinds of medical devices
to which the certificate applies; or
(e) at least one of the following persons:
(i) the person (the holder) in relation to whom the
certificate is issued;
(ii) a person (a manager) who makes, or participates in
making, decisions that affect the whole, or a substantial
part, of the holder’s affairs;
(iii) if the holder is a body corporate—a major interest
holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a
corresponding State law; or
(v) been convicted of an offence against a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
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Section 41ET
(vi) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of this Act or
a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the
contravention of a civil penalty provision of a law of the
Commonwealth or a law of a State or Territory
involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment
document; or
(ix) had a conformity assessment document suspended or
revoked; or
(x) been a manager, or a major interest holder, of a body
corporate in respect of which subparagraph (iv), (v),
(vi), (vii), (viii) or (ix) applies, if the conduct resulting
in that subparagraph applying occurred when the person
was a manager or major interest holder of the body
corporate; or
(f) any other circumstances prescribed by the regulations for the
purposes of this paragraph exist.
(1A) A reference in paragraph (1)(e) to a person convicted of an offence
includes a reference to a person in respect of whom an order has
been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found
a person to have committed an offence to take action without
proceeding to record a conviction.
(1B) Paragraph (1)(e) does not limit paragraph (1)(f).
(2) However, before revoking the certificate, the Secretary must:
(a) inform the person in writing that the Secretary proposes the
revocation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
revocation.
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Section 41EU
(3) The Secretary is not to make a decision relating to the proposed
revocation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) Nothing in this section affects the operation of Part VIIC of the
Crimes Act 1914 (which includes provisions that, in certain
circumstances, relieve persons from the requirement to disclose
spent convictions and require persons aware of such convictions to
disregard them).
41EU Limiting revocation of conformity assessment certificates to
some medical devices of a particular kind
(1) If the Secretary is satisfied that the ground for revoking a
conformity assessment certificate applies only to:
(a) some of the kinds of medical devices to which the certificate
applies; or
(b) some medical devices of the kinds to which the certificate
applies;
the Secretary must limit the revocation to the medical devices to
which that ground or any other ground for revocation applies.
(2) If the revocation of the certificate is so limited, the Secretary must
vary the certificate so that it no longer applies to the medical
devices referred to in subsection (1).
41EV Publication of revocation etc. of conformity assessment
certificates
The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after revoking a
conformity assessment certificate, or varying a conformity
assessment certificate under subsection 41EU(2), a notice setting
out particulars of the revocation or variation.
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Section 41EW
41EW Date of effect of revocation etc. of conformity assessment
certificates
If the Secretary revokes a conformity assessment certificate, or
varies a conformity assessment certificate under
subsection 41EU(2), the revocation or variation has effect:
(a) if the revocation is under section 41ER or 41ES, or the
variation relates to a ground of revocation in section 41ER or
41ES—on the day on which the notice of revocation or
variation is given to the person in relation to whom the
certificate was issued; or
(b) in any other case—on such later day as is specified in the
notice.
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Part 4-4A Australian conformity assessment bodies
Section 41EWA
Part 4-4A—Australian conformity assessment
bodies
41EWA Conformity assessment body determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make conformity assessment body
determinations.
(2) A conformity assessment body determination is a determination
that a specified Australian corporation is an Australian conformity
assessment body for the purposes of this Act.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for conformity assessment body determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) the lapsing of such an application;
(f) the assessment by the Secretary of whether a conformity
assessment body determination should be made in response
to such an application;
(g) the assessment fee for such an assessment;
(h) the duration of conformity assessment body determinations.
(4) A conformity assessment body determination:
(a) may be of general application; or
(b) may be limited to either or both of the following:
(i) one or more specified medical devices;
(ii) one or more specified conformity assessment
procedures.
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(4A) If under the regulations the Secretary makes a conformity
assessment body determination, the Secretary must assign a unique
identification number to the body.
(4B) The Secretary must publish a list of the Australian conformity
assessment bodies on the Department’s website.
(4C) The Secretary may also publish on the Department’s website any
information relating to Australian conformity assessment bodies
and either to conformity assessment body determinations or to
certification-related activities of Australian conformity assessment
bodies.
(5) The regulations may provide that a conformity assessment body
determination is subject to:
(a) the conditions prescribed by the regulations; and
(b) such other conditions (if any) as are specified in the
determination.
Note: See subsections 41MN(10) to (12) and 41MNA(3) for offences and a
civil penalty for a breach of the conditions.
(6) The following are examples of conditions that may be prescribed:
(a) a condition that the body will allow an authorised person:
(i) to enter, at any reasonable time, premises used by the
body to carry on certification-related activities; and
(ii) while on those premises, to inspect those premises and
anything on those premises that concerns
certification-related activities carried on by the body;
and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or anything on
those premises that concerns certification-related
activities carried on by the body; and
(iv) while on those premises, to inspect, and make copies of,
any documents that concern certification-related
activities carried on by the body;
(b) a condition that the body will, if requested to do so by the
Secretary, give the Secretary information, or produce to the
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Secretary documents, that concern certification-related
activities carried on by the body.
(6A) The regulations may make provision for and in relation to the
effect on an Australian conformity assessment body certificate of
the Australian conformity assessment body ceasing to carry on
certification-related activities.
(6B) Without limiting subsection (6A), regulations made for the
purposes of that subsection may make provision in relation to a
matter by conferring on the Secretary a power to make a decision
of an administrative character.
(7) The regulations may make provision for and in relation to
empowering the Secretary to revoke, suspend or vary a conformity
assessment body determination.
(7A) If under the regulations the Secretary suspends a conformity
assessment body determination, the conditions referred to in
subsection (5) continue during the suspension.
(8) Subsections (3) to (7) do not limit subsection (1).
(9) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(10) If a conformity assessment body determination is in force under the
regulations, the determination must be published on the
Department’s website.
(11) A conformity assessment body determination made under the
regulations is not a legislative instrument.
(12) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of an Australian corporation in a
conformity assessment body determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
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Section 41EWB
41EWB Content of Australian conformity assessment body
certificates
(1) An Australian conformity assessment body certificate that is issued
to a manufacturer of medical devices must specify whether it
covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the
manufacturer.
(2) An Australian conformity assessment body certificate must contain
any other information prescribed by the regulations for the
purposes of this subsection.
(3) An Australian conformity assessment body certificate may be
subject to conditions specified in the certificate.
41EWC Duration of Australian conformity assessment body
certificates
(1) An Australian conformity assessment body certificate commences
on the day specified for the purpose in the certificate. The
certificate must specify the period for which it is to be in force
(which must be no longer than 5 years).
(2) An Australian conformity assessment body certificate has effect at
all times:
(a) unless the certificate is suspended by the Australian
conformity assessment body; or
(b) until the end of the period specified in the certificate, or if the
Australian conformity assessment body extends that period,
until the end of that extended period; or
(c) until the certificate is revoked by the Australian conformity
assessment body.
Extensions
(3) An Australian conformity assessment body that has issued an
Australian conformity assessment body certificate may, in writing
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and on its own initiative, extend the period for which the certificate
is in force.
(4) An extension must be no longer than 12 months.
(5) Only one extension may be given.
(6) The Australian conformity assessment body must give notice of an
extension to the person to whom the certificate was issued.
41EWD Record-keeping
(1) If an Australian corporation:
(a) is an Australian conformity assessment body; and
(b) is required by a condition referred to in
subsection 41EWA(5) to keep records relating to
certification-related activities carried on by the corporation;
the Australian corporation must keep the records at all times while
the corporation is an Australian conformity assessment body.
(2) If the Australian corporation ceases to be an Australian conformity
assessment body, the corporation must keep the records referred to
in subsection (1) for 15 years after that cessation.
Offences
(3) An Australian corporation commits an offence if:
(a) the corporation is subject to a requirement under this section;
and
(b) the corporation contravenes the requirement.
Penalty: 1,200 penalty units.
(4) An Australian corporation commits an offence if:
(a) the corporation is subject to a requirement under this section;
and
(b) the corporation contravenes the requirement.
Penalty: 300 penalty units.
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(5) An offence against subsection (4) is an offence of strict liability.
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Part 4-5 Including medical devices in the Register
Section 41F
Part 4-5—Including medical devices in the Register
41F What this Part is about
Kinds of medical devices can be included in the Register if they
comply with the essential principles, and conformity assessment
procedures have been applied to the kinds of devices or
requirements, comparable to those procedures, have been applied
to the kinds of devices (and certain other requirements are
complied with).
Inclusions in the Register are subject to certain automatic
conditions and the Secretary may impose further conditions.
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Section 41FA
Division 1—Including medical devices in the Register
41FA What this Division is about
Kinds of medical devices are usually included in the Register once
an application is made, together with the required certification and
the application passes preliminary assessment. However,
applications may be selected for audit, which involves checking
some or all aspects of the application and certification.
Note 1: In some cases, an application relating to a kind of medical device will
not pass preliminary assessment unless that kind of device is covered
by a conformity assessment certificate under Part 4-4: see
paragraph 41FDB(2)(e).
Note 2: Dealing in medical devices of a kind not included in the Register may
be an offence or may contravene a civil penalty provision: see
Division 3 of Part 4-11.
Subdivision A—Applications
41FC Making an application
(1) A person may make an application to the Secretary for a kind of
medical device to be included in the Register.
(2) An application must not contain information that is false or
misleading in a material particular.
Note: A person might also commit an offence, or contravene a civil penalty
provision, if the person makes a statement in an application that is
false or misleading in a material particular: see sections 41FE and
41FEA.
41FD Matters to be certified
The applicant must certify that:
(a) devices of the kind in question are medical devices; and
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(b) devices of that kind are intended for a specified purpose, as
ascertained under subsection 41BD(2); and
(c) the kind of device is correctly classified according to the
medical device classifications; and
(d) devices of that kind comply with the essential principles; and
(e) the applicant:
(i) has available sufficient information to substantiate that
compliance with the essential principles; or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(f) either:
(i) appropriate conformity assessment procedures have
been applied to devices of that kind; or
(ii) requirements, comparable to the conformity assessment
procedures, have been applied to devices of that kind;
and
(g) the applicant:
(i) has available sufficient information to substantiate the
application of the procedures referred to in
subparagraph (f)(i) or the requirements referred to in
subparagraph (f)(ii); or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(h) both of the following are complied with in relation to devices
of that kind:
(i) the applicable provisions of the Therapeutic Goods
Advertising Code;
(ii) the other requirements (if any) relating to advertising
applicable under Part 5-1 or under the regulations; and
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Section 41FDA
(i) devices of that kind do not contain substances that are
prohibited imports for the purposes of the Customs Act 1901;
and
(ia) devices of that kind are not to be used exclusively for one or
more of the purposes specified under section 41BEA; and
(j) the information included in or with the application is
complete and correct.
Note: See section 41BH for when a medical device complies with the
essential principles, section 41BI for when conformity assessment
procedures are taken not to have been applied to a medical device and
section 41BIA for when requirements comparable to those procedures
are taken not to have been applied to a medical device.
41FDA Basis of certification of conformity assessment procedures
When certifying the matter referred to in paragraph 41FD(f), the
applicant must also state that the certification of the matter is
based:
(a) on a conformity assessment certificate that is in force; or
(b) on an Australian conformity assessment body certificate that
is in force; or
(c) on an overseas regulator conformity assessment document
that is in force.
41FDB Preliminary assessment of applications
(1) If an application is made under section 41FC for a kind of medical
device to be included in the Register in relation to a person, the
Secretary must carry out an assessment of whether the
requirements set out in subsection (2) have been met in relation to
the application.
(2) The requirements are as follows:
(a) the application must be made:
(i) in accordance with the form approved, in writing, by the
Secretary for that classification of medical device; or
(ii) in such other manner as is approved, in writing, by the
Secretary for that classification of medical device;
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Section 41FDB
(b) the prescribed application fee for that classification of
medical device must be paid;
(c) the application must be delivered to an office of the
Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (7) for that
classification of medical device; and
(ii) in a form determined under subsection (8) for that
classification of medical device;
(e) if regulations made for the purposes of section 41EA require
the manufacturer of the kind of device to have a conformity
assessment certificate relating to the kind of medical device
before an application under section 41FC can be made—such
a certificate is in force;
(f) the applicant has certified the matters in section 41FD.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (2)
have been met in relation to the application.
(4) If the application has not passed preliminary assessment, the
Secretary must refuse the application.
Note: The Secretary is required to give notice of the refusal: see
section 41FG.
Approval of forms etc.
(5) For the purposes of paragraph (2)(a), the Secretary may approve
different forms and different manners for making applications for
different medical device classifications.
(6) An approval of a form may require or permit an application or
information to be given in accordance with specified software
requirements:
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(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
Determination of kinds and forms of information
(7) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of the application of
subparagraph (2)(d)(i) to medical devices of a particular
classification.
(8) The Secretary may, by legislative instrument, determine a form of
information for the purposes of the application of
subparagraph (2)(d)(ii) to medical devices of a particular
classification.
41FE Criminal offences for making a false statement
(1) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the person knows that the statement is false or misleading in
a material particular; and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD; and
(d) either:
(i) the use of the kind of medical device has resulted in,
will result in, or is likely to result in, harm or injury to
any person; or
(ii) the use of the kind of medical device, if the kind of
medical device were used, would result in, or would be
likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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Note 1: A jury may acquit a person of an offence against this subsection and
may convict the person of an offence against subsection (4) instead:
see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see
sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the person knows that the statement is false or misleading in
a material particular; and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(5) A person commits an offence if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Penalty: 100 penalty units.
(6) An offence against subsection (5) is an offence of strict liability.
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41FEA Civil penalty for making a false statement
A person contravenes this section if:
(a) the person makes a statement (whether orally, in a document
or in any other way); and
(b) the statement is false or misleading in a material particular;
and
(c) the statement is in or in connection with:
(i) an application for including a kind of medical device in
the Register under this Chapter; or
(ii) a certification or purported certification under
section 41FD.
Maximum civil penalty:
(a) for an individual—5,000 penalty units; and
(b) for a body corporate—50,000 penalty units.
Subdivision B—Including kinds of medical devices in the
Register
41FF Obligation to include kinds of medical devices in the Register
(1) If:
(a) an application for a kind of medical device to be included in
the Register in relation to a person has passed preliminary
assessment; and
(b) the application has not been selected for audit under
section 41FH;
the Secretary must include the kind of device in the Register in
relation to the person.
(1A) However, the Secretary must not include the kind of device in the
Register in relation to the person if the Secretary is satisfied that
the kind of device is to be used exclusively for one or more of the
purposes specified under section 41BEA.
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Section 41FG
(2) As soon as practicable after the kind of device has been included in
the Register, the Secretary must make available to the applicant a
certificate of the inclusion of the kind of device in the Register.
(3) The certificate must specify the day on which the inclusion of the
kind of device in the Register commences.
41FG Notification of unsuccessful applications
(1) This section applies if an application under subsection 41FC(1) for
a kind of medical device to be included in the Register:
(a) is refused under subsection 41FDB(4); or
(b) is refused under subsection 41FF(1A).
(2) The Secretary must notify the applicant in writing, of the refusal
within 20 working days after the application has been received and
the prescribed application fee has been paid.
Subdivision C—Auditing of applications
41FH Selecting applications for auditing
(1A) This section applies to applications that have passed preliminary
assessment.
(1) The Secretary:
(a) must select for auditing any application for a kind of medical
device to be included in the Register that is an application of
the kind prescribed by the regulations; and
(b) may select for auditing any other application for a kind of
medical device to be included in the Register.
Note: An application audit assessment fee is payable in respect of any
application that the Secretary must select for auditing: see Part 4-10.
(2) If an application is selected for auditing:
(a) the Secretary must give the applicant a written notice (the
selection notice) that:
(i) informs the applicant of the selection; and
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(ii) requires the applicant to provide, within the period
specified in the notice, information or documents that
the Secretary is satisfied is relevant to the audit; and
(b) the application must be dealt with under this Subdivision and
not under Subdivision B.
(3) The selection notice must be given within:
(a) 20 working days after the application is made and the
prescribed application fee is paid; or
(b) if the regulations prescribe a longer period for that kind of
application—that longer period.
(4) Subparagraph (2)(a)(ii) does not limit section 41JA (Secretary may
require information).
41FI Auditing of applications
(1) In auditing the application, the Secretary may consider all or some
aspects of one or both of the following matters:
(a) whether the application is in accordance with Subdivision A;
(b) whether matters as to which the applicant has certified under
section 41FD are correct.
(1A) In auditing the application, the Secretary may, by written notice
given to the applicant, require the applicant:
(a) to deliver to the office to which the application was made a
reasonable number of samples of the kind of medical device
to which the application relates within the period, of not less
than 14 days after the day the notice is given, specified in the
notice; and
(b) to do so in a manner specified in the notice.
(2) The Secretary must decide to include the kind of device to which
the application relates in the Register, in relation to the person to
whom the application relates, if the Secretary is satisfied as to all
such aspects considered in the audit.
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Section 41FIA
(3) The Secretary must decide not to include the kind of device to
which the application relates in the Register if the Secretary is not
so satisfied.
41FIA Certificates issued by Australian conformity assessment
bodies
(1) If:
(a) a section 41FC application is made for a kind of medical
device to be included in the Register; and
(b) the application has been selected for audit; and
(c) a person has obtained a certificate issued by an Australian
conformity assessment body to the effect that the body is
satisfied that an appropriate conformity assessment procedure
has been applied to devices of that kind; and
(d) the certificate has been given to the Secretary; and
(e) if the conformity assessment body determination that relates
to the body is limited as mentioned in
paragraph 41EWA(4)(b)—the Secretary is satisfied that the
certificate has been issued consistently with the
determination;
the Secretary may have regard to the certificate in auditing the
application.
(2) This section does not, by implication, limit the matters to which the
Secretary may have regard.
41FJ Procedure following audits
After auditing the application, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) if the decision is not to include the kind of device to which
the application relates in the Register—state in the notice the
reasons for the decision; and
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(c) if the decision is to include the kind of device in the Register
and all assessment fees for the application that are due and
payable have been paid:
(i) include the kind of device in the Register, in relation to
the person in relation to whom the application was
made; and
(ii) give the applicant a certificate of the inclusion of the
kind of device in the Register.
41FK Lapsing of applications
An application that has been selected for auditing lapses if:
(a) the applicant fails to comply with a notice under
section 41FH within 10 working days after the end of the
period specified in the notice; or
(b) the applicant does not comply with a requirement by the
Secretary under subsection 41FI(1A) to deliver to the office
to which the application was made a reasonable number of
samples of the kind of medical device to which the
application relates; or
(c) the applicant fails to comply with a notice under
section 41JA to give information relating to devices of that
kind to the Secretary within a further 10 working days from
the day specified in the notice; or
(d) information given to the Secretary by, or on behalf of, the
applicant in connection with the application, including
information given for the purpose of a requirement under
section 41JA, is false or misleading in a material particular;
or
(e) the applicant fails to pay an assessment fee for the
application in accordance with section 41LB or 41LC.
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Section 41FKA
Subdivision D—Miscellaneous
41FKA Medical devices (priority applicant) determinations
(1) The regulations may make provision for and in relation to
empowering the Secretary to make medical devices (priority
applicant) determinations.
(2) A medical devices (priority applicant) determination is a
determination that, for the purposes of this Act, a specified person
is a priority applicant in relation to any section 41FC application
that may be made by the person for the inclusion in the Register of
a medical device of a kind specified in the determination.
(3) The regulations may make provision for and in relation to the
following matters:
(a) applications for medical devices (priority applicant)
determinations;
(b) the approval by the Secretary of a form for such an
application;
(c) information that must accompany such an application;
(d) the application fee for such an application;
(e) empowering the Secretary to give the applicant a written
notice requiring the applicant to give to the Secretary
specified information or documents in connection with the
application within a specified period (which must be at least
10 working days after the notice is given to the applicant).
(4) The regulations may make provision for and in relation to the
following matters:
(a) empowering the Secretary to revoke a medical devices
(priority applicant) determination;
(b) the consequences of the revocation of a medical devices
(priority applicant) determination.
(5) Subsections (3) and (4) do not limit subsection (1).
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(6) The regulations may make provision for and in relation to the
priority to be given by the Secretary to consideration of a
section 41FC application where the applicant is a priority
applicant.
(7) The regulations may provide that, if:
(a) a person is a priority applicant in relation to a section 41FC
application made by the person; and
(b) a decision is made on the application;
a statement setting out the decision may be published on the
Department’s website.
(8) The express references in this section to the Secretary do not, by
implication, prevent the regulations from empowering the
Secretary to delegate any or all of the Secretary’s functions or
powers under regulations made for the purposes of this section.
(9) If a medical devices (priority applicant) determination is in force
under the regulations, the determination may be published on the
Department’s website.
(10) A medical devices (priority applicant) determination made under
the regulations is not a legislative instrument.
(11) Subsection 33(3AB) of the Acts Interpretation Act 1901 does not
apply to the specification of a person in a medical devices (priority
applicant) determination.
Note: Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with
specification by class.
41FL Device number
If a kind of medical device is included in the Register, the
Secretary is to assign a unique device number to it.
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Section 41FM
41FM Duration of inclusion in the Register
(1) The inclusion of a kind of medical device in the Register
commences on the day specified for the purpose in the certificate
under section 41FF or 41FJ.
(2) The inclusion of a kind of medical device in the Register has effect
at all times:
(a) unless the kind of device is suspended from the Register
under Division 1 of Part 4-6; or
(b) until entry of the kind of device is cancelled from the
Register under Division 2 of Part 4-6.
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Section 41FN
Division 2—Conditions
Note: Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4-6), may be an offence (see subsections 41MN(1), (4) and (4A)), and may contravene a civil penalty provision (see subsection 41MNA(1)).
41FN Conditions applying automatically
Entry and inspection powers
(1) The inclusion of a kind of medical device in the Register is subject
to the conditions that the person in relation to whom the kind of
device is included in the Register will:
(a) allow an authorised person:
(i) to enter, at any reasonable time, any premises (including
premises outside Australia) at which that person or any
other person deals with medical devices of that kind;
and
(ii) while on those premises, to inspect those premises and
medical devices of any kind on those premises and to
examine, take measurements of, conduct tests on,
require tests to be conducted on or take samples of
medical devices of any kind on those premises or any
thing on those premises that relates to medical devices
of any kind; and
(iii) while on those premises, to make any still or moving
image or any recording of those premises or any thing
on those premises; and
(b) if requested to do so by an authorised person, produce to the
person such documents relating to devices of the kind
included in the Register as the person requires and allow the
person to copy the documents.
Delivery of samples
(2) The inclusion of a kind of medical device in the Register is subject
to a condition that the person in relation to whom the kind of
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device is included in the Register will deliver a reasonable number
of samples of the kind of device if the Secretary so requests:
(a) within the period specified in the request; and
(b) in accordance with any other requirements specified in the
request.
The period specified in the request must include at least 10
working days.
Availability etc. of information
(3) The inclusion of a kind of medical device in the Register is subject
to conditions that:
(a) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register:
(i) has available sufficient information to substantiate
compliance with the essential principles; or
(ii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(b) at all times while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register:
(i) has available sufficient information to substantiate that
the conformity assessment procedures have been
applied to the kind of medical device or that
requirements, comparable to those procedures, have
been applied to the kind of medical device to the
satisfaction of an overseas regulator; or
(ii) has available information relating to changes to the kind
of medical device, the product range, and quality
management system, of the manufacturer of the device;
or
(iii) has procedures in place, including a written agreement
with the manufacturer of the kind of devices setting out
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the matters required by the regulations, to ensure that
such information can be obtained from the manufacturer
within the period specified in the regulations; and
(c) at any time while the inclusion in the Register has effect, the
person in relation to whom the kind of device is included in
the Register will, if asked to do so by the Secretary, give the
information to the Secretary; and
(d) the person in relation to whom the kind of device is included
in the Register will give information of a kind mentioned in
subsection 41MP(2) or 41MPA(2) to the Secretary within the
period specified in the regulations; and
(e) the person in relation to whom the kind of device is included
in the Register will give the manufacturer of the kind of
medical device information relevant to:
(i) the manufacturer’s obligations under the conformity
assessment procedures or requirements comparable to
those procedures; and
(ii) whether medical devices of that kind comply with the
essential principles.
(4) The regulations may prescribe the amount, standard or kind of
information or evidence required for the purposes of
paragraphs (3)(c), (d) and (e).
Advertising material
(5) The inclusion of a kind of medical device in the Register is subject
to a condition that advertising material relating to medical devices
of that kind is consistent with the intended purpose as certified
under section 41FD.
Conditions prescribed by the regulations
(5A) The inclusion of a kind of medical device in the Register is subject
to such conditions (if any) as are prescribed by the regulations.
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Section 41FO
Conditions determined by the Minister
(5B) The inclusion of a kind of medical device in the Register is subject
to such conditions (if any) as are determined under
subsection (5C).
(5C) The Minister may, by legislative instrument, determine one or
more conditions for the purposes of subsection (5B).
Conditions do not limit other conditions
(6) A condition imposed under this section is in addition to any
conditions imposed under this Division.
41FO Conditions imposed when kinds of medical devices are
included in the Register
(1) If the Secretary includes a kind of medical device in the Register in
relation to a person, the Secretary may, in writing, impose
conditions on the inclusion of the kind of device in the Register.
(2) Conditions referred to in subsection (1) may relate to:
(a) manufacture of devices of that kind; or
(b) custody, intended purpose, supply, disposal or destruction of
devices of that kind; or
(c) keeping of records relating to devices of that kind, including
records relating to the tracking and location of devices of that
kind after their supply; or
(d) matters dealt with in, or matters additional to matters dealt
with in, the essential principles; or
(e) such other matters relating to devices of that kind as the
Secretary thinks appropriate.
41FP Conditions imposed after kinds of medical devices are
included in the Register
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register:
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(a) impose new conditions on including the kind of device in the
Register under this Chapter; or
(b) vary or remove existing conditions.
The power may be exercised at the person’s request or on the
Secretary’s own initiative.
(2) The imposition, variation or removal of a condition under this
section takes effect:
(a) if the notice states that the action is necessary to prevent
imminent risk of death, serious illness or serious injury—on
the day on which the notice is given to the person; or
(aa) in the case of an imposition or variation requested by the
person, and to which paragraph (a) does not apply—on the
day specified in the notice, which must be at least 20 working
days after the notice is given to the person, unless the person
has agreed to an earlier day; or
(ab) in the case of a removal to which paragraph (a) does not
apply—on the day specified in the notice, which must be at
least 20 working days after the notice is given to the person,
unless the person has agreed to an earlier day; or
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(3) For the purposes of paragraphs (2)(aa) and (ab), the earlier day
must not be earlier than the day the notice is given to the person.
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Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41G
Part 4-6—Suspension and cancellation from the
Register
Division 1—Suspension from the Register
Subdivision A—General power of suspension
41G What this Part is about
Inclusions in the Register may be suspended in certain
circumstances, such as when a conformity assessment document is
suspended. A kind of medical device that is suspended is taken not
to be included in the Register for most purposes.
Inclusions in the Register may also be cancelled in certain
circumstances.
41GA Suspension of kinds of medical devices from the Register
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or
serious injury if the kind of device continues to be
included in the Register; and
(ii) it is likely that the person will, within the period of the
suspension, be able to take the action necessary to
ensure that the kind of device would not cause a
potential risk of death, serious illness or serious injury if
it were to continue to be included in the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds
for cancelling the entry of the kind of device from the
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Section 41GB
Register under Division 2 (other than under
paragraph 41GL(a), (d) or (f) or section 41GM).
(2) The suspension may be limited to some medical devices of that
kind, as specified in the notice.
(3) The notice must specify the period of the suspension. The period
must not exceed 6 months.
Note: The period of the suspension may be extended under section 41GC.
(4) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the suspension,
a notice setting out particulars of the suspension.
41GB Notice of proposed suspension must be given in certain cases
(1) However, before suspending a kind of medical device from the
Register because it is likely that there are grounds for cancelling
the entry of the kind of device from the Register under
section 41GN, the Secretary must:
(a) inform the person by written notice that the Secretary
proposes the suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(2) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (1)(b).
41GC Duration of suspension
(1) The suspension takes effect:
(a) if the notice under subsection 41GA(1) states that the
suspension is necessary to prevent a potential risk of death,
serious illness or serious injury—on the day on which the
notice is given to the person; or
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Division 1 Suspension from the Register
Section 41GD
(b) in any other case—on the day specified for the purpose in the
notice, being a day not earlier than 20 working days after the
notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 41GD; or
(b) the end of:
(i) the period specified in the notice under
subsection 41GA(3); or
(ii) if the period is extended under subsection (3) of this
section, the period as so extended.
Note: Unless a suspension of a kind of medical device has been revoked, the
entry of the kind of medical device is automatically cancelled from the
Register: see section 41GK.
(3) If a person in relation to whom a kind of medical device is
included in the Register shows that he or she has taken steps to
remove the grounds for cancelling the entry of the kind of device
from the Register under section 41GN, the Secretary may, by
written notice given to the person, extend the period specified in
the notice under subsection 41GA(1) by a further specified period
not exceeding 6 months.
(4) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the extension, a
notice setting out particulars of the extension.
41GD Revocation of suspension
(1) The Secretary must revoke the suspension if the Secretary is
satisfied that:
(a) the ground on which the kind of medical device concerned
was suspended from the Register no longer applies; and
(b) there are no other grounds for suspending the kind of device
from the Register.
(2) The Secretary’s power to revoke the suspension may be exercised:
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GE
(a) if the person in relation to whom the kind of medical device
concerned is included in the Register applies in writing to the
Secretary; or
(b) on the Secretary’s own initiative.
(3) After revoking the suspension, the Secretary must:
(a) within 20 working days after the revocation, give written
notice of the revocation to the person in relation to whom the
kind of medical device concerned is included in the Register;
and
(b) as soon as practicable after the revocation, cause to be
published in the Gazette or on the Department’s website a
notice setting out particulars of the revocation.
(4) If the Secretary decides, after an application is made under
paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision within 20
working days after the decision is made; and
(b) state in the notice the reasons for the decision.
41GE Treating applications for revocation as having been refused
(1) The applicant for the suspension to be revoked may give the
Secretary written notice that the applicant wishes to treat the
application as having been refused if:
(a) a period is prescribed under paragraph 63(2)(dd) for the
Secretary to make a decision on the application; and
(b) at the end of the period, the Secretary has not made a
decision.
(2) The notice may be given at any time before the Secretary makes a
decision on the application.
(3) If a notice has been given, this Act (except for subsection 60(5)) has
effect as if:
(a) the Secretary had decided not to revoke the suspension; and
(b) the Minister had made a decision under subsection 60(3)
confirming the decision of the Secretary; and
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Chapter 4 Medical devices
Part 4-6 Suspension and cancellation from the Register
Division 1 Suspension from the Register
Section 41GF
(c) the Minister’s decision had been made on the day on which
notice was given to the Secretary.
Subdivision B—Suspension as a result of suspension of
conformity assessment document
41GF Suspension where conformity assessment certificate
suspended
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if the conformity
assessment certificate applying to that kind of device is suspended
under Division 3 of Part 4-4.
(2) If the suspension under Division 3 of Part 4-4 is limited to some
medical devices of that kind, the suspension under this section is
taken to be limited to the same extent.
(3) The Secretary must cause to be published in the Gazette or on the
Department’s website, as soon as practicable after the suspension,
a notice setting out particulars of the suspension.
41GFA Suspension where other certificates or documents are
suspended
(1) The Secretary may, by written notice given to the person in relation
to whom a kind of medical device is included in the Register,
suspend the kind of device from the Register if:
(a) an Australian conformity assessment body certificate that
applies to the kind of device is suspended by the Australian
conformity assessment body; or
(b) an overseas regulator conformity assessment document that
applies to the kind of device is suspended by the overseas
regulator.
(2) However, before suspending the kind of device from the Register,
the Secretary must:
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Medical devices Chapter 4
Suspension and cancellation from the Register Part 4-6
Suspension from the Register Division 1
Section 41GG
(a) inform the person in writing that the Secretary proposes the
suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make
submissions to the Secretary in relation to the proposed
suspension.
(3) The Secretary is not to make a decision relating to the proposed
suspension until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).
(4) The Secretary must cause to be published on the Department’s
website, as soon as practicable after the suspension, a notice setting
out particulars of the suspension.
41GG Duration of suspension
(1) A suspension under section 41GF or 41GFA takes effect on the
day on which the notice is given to the person.
(2) The suspension has effect until the Secretary revokes it under
section 41GH.
41GH Revocation of suspension
(1) The Secretary must revoke a suspension under section 41GF if:
(a) the suspension under Division 3 of Part 4-4 ceases to have
effect; and
(b) the Secretary is satisfied that there are no other grounds for
suspending the kind of device from the Register.
(1A) The Secretary may revoke a suspension under section 41GFA if:
(a) either:
(i) the suspension referred to in paragraph 41GFA(1)(a) or
(b) ends; or
(ii) the person in relation to whom the kind of medical
device is included in the Register provides the Secretary
with another conformity assessment document that
applies to the kind of device; and
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