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Therapeutic Goods Act 1989 (consolidated as of January 1, 2019), Australia

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Details Details Year of Version 2019 Dates Entry into force: February 15, 1991 Adopted: January 17, 1991 Type of Text IP-related Laws Subject Matter Patents (Inventions)

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Main text(s) Main text(s) English Therapeutic Goods Act 1989 (consolidated as of January 1, 2019)        

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If a provision of the compiled law has been repealed in accordance with a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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Section 3

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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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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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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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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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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Section 21

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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(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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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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Section 26AC

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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Section 26AE

(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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Section 26BC

(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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(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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Reporting medicine shortages and discontinuation of supply of medicine Division 2B

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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Section 30F

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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Section 30F

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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Section 31A

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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Section 31B

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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Section 31BA

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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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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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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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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(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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(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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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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(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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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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(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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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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Main criminal offences and civil penalties Division 2

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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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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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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Section 32CC

(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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Section 32CE

(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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Section 32CH

(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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Section 32CJ

(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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Section 32CJ

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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Section 32CK

(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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Section 32CN

(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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Section 32CN

(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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(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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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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(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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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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(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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(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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(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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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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(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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(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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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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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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(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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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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(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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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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(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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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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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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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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Section 32JF

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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Section 32JI

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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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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(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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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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Section 41AG

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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Chapter 4 Medical devices

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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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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Division 3 Application provisions

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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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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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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Conformity assessment procedures Division 1

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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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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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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Division 2 Conditions

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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Division 3 Suspension of conformity assessment certificates

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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Division 4 Revocation of conformity assessment certificates

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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Section 41EWA

(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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Section 41EWA

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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Section 41FD

(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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(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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(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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(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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