Note: An electronic version of this Act is available on the Federal Register of Legislation
(https://www.legislation.gov.au/)
Therapeutic Goods Amendment (2020
Measures No. 1) Act 2020
No. 75, 2020
An Act to amend the Therapeutic Goods Act 1989,
and for related purposes
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No. 75, 2020 Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 i
Contents 1 Short title ...........................................................................................1
2 Commencement.................................................................................2
3 Schedules...........................................................................................2
Schedule 1—Medical devices 3
Part 1—Medical device definitions 3
Therapeutic Goods Act 1989 3
Part 2—Basis of certification of conformity assessment
procedures 5
Therapeutic Goods Act 1989 5
Part 3—Cancellation of entries of kinds of medical devices
from the Register 6
Therapeutic Goods Act 1989 6
Part 4—Medical device standards and conformity assessment
standards 7
Therapeutic Goods Act 1989 7
Schedule 2—Scientific advice about quality, safety and efficacy
of medicine 8
Therapeutic Goods Act 1989 8
Schedule 3—Variations to approved clinical trials 11
Therapeutic Goods Act 1989 11
Schedule 4—Preliminary assessment of applications for
variation of permissible ingredients determination 15
Therapeutic Goods Act 1989 15
Schedule 5—Approving supply of therapeutic goods under
authorised prescriber scheme 20
Therapeutic Goods Act 1989 20
Schedule 6—Removal of offences for person claiming to be able
to arrange supply of therapeutic goods 22
Therapeutic Goods Act 1989 22
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Schedule 7—Conditions of registration or listing of therapeutic
goods 23
Therapeutic Goods Act 1989 23
Schedule 8—Changes to provisionally registered medicine 24
Therapeutic Goods Act 1989 24
Schedule 9—Data protection for certain listed medicine 29
Therapeutic Goods Act 1989 29
Schedule 10—Other amendments 31
Patents Act 1990 31
Therapeutic Goods Act 1989 31
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No. 75, 2020 Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 1
Therapeutic Goods Amendment (2020
Measures No. 1) Act 2020
No. 75, 2020
An Act to amend the Therapeutic Goods Act 1989,
and for related purposes
[Assented to 25 June 2020]
The Parliament of Australia enacts:
1 Short title
This Act is the Therapeutic Goods Amendment (2020 Measures
No. 1) Act 2020.
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2 Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 No. 75, 2020
2 Commencement
(1) Each provision of this Act specified in column 1 of the table
commences, or is taken to have commenced, in accordance with
column 2 of the table. Any other statement in column 2 has effect
according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent. 25 June 2020
2. Schedule 1,
Part 1
The later of:
(a) 25 August 2020; and
(b) the 28th day after this Act receives the
Royal Assent.
25 August 2020
(paragraph (a)
applies)
3. Schedule 1,
Parts 2 to 4
The day after this Act receives the Royal
Assent.
26 June 2020
4. Schedules 2 to
4
The 28th day after this Act receives the
Royal Assent.
23 July 2020
5. Schedules 5 to
10
The day after this Act receives the Royal
Assent.
26 June 2020
Note: This table relates only to the provisions of this Act as originally
enacted. It will not be amended to deal with any later amendments of
this Act.
(2) Any information in column 3 of the table is not part of this Act.
Information may be inserted in this column, or information in it
may be edited, in any published version of this Act.
3 Schedules
Legislation that is specified in a Schedule to this Act is amended or
repealed as set out in the applicable items in the Schedule
concerned, and any other item in a Schedule to this Act has effect
according to its terms.
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Medical devices Schedule 1
Medical device definitions Part 1
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Schedule 1—Medical devices
Part 1—Medical device definitions
Therapeutic Goods Act 1989
1 Subsection 3(1) (definition of accessory)
After “enable”, insert “or assist”.
2 Paragraph 7B(1)(b)
Omit “or a system or procedure pack”.
3 Paragraph 41BD(1)(a)
After “appliance,”, insert “software, implant, reagent,”.
4 Subparagraph 41BD(1)(a)(i)
After “monitoring,”, insert “prediction, prognosis,”.
5 Subparagraph 41BD(1)(a)(iii)
Omit “physiological process”, substitute “physiological or pathological
process or state”.
6 Subparagraph 41BD(1)(a)(iv)
After “control”, insert “or support”.
7 After subparagraph 41BD(1)(a)(iv)
Insert:
(v) in vitro examination of a specimen derived from the
human body for a specific medical purpose;
8 Paragraph 41BD(1)(aa)
After “appliance,”, insert “software, implant, reagent,”.
9 Paragraph 41BD(1)(ab)
After “appliance,”, insert “software, implant, reagent,”.
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Part 1 Medical device definitions
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10 Paragraph 41BD(1)(ab)
After “appliances,”, insert “software, implants, reagents,”.
11 Paragraph 41BD(1)(b)
After “appliance,”, insert “software, implant, reagent,”.
12 After paragraph 41BD(1)(b)
Insert:
; or (c) a system or procedure pack.
13 Subsection 41BD(2)
After “appliance,”, insert “software, implant, reagent,”.
14 Subsection 41BD(2A)
After “appliance,”, insert “software, implant, reagent,”.
15 Subsection 41BD(2B)
After “appliances,”, insert “software, implants, reagents,”.
16 Subsection 41BD(3)
After “appliance,”, insert “software, implant, reagent,”.
17 Subsection 41BD(3)
After “appliances,”, insert “software, implants, reagents,”.
18 Section 41BF
Repeal the section, substitute:
41BF System or procedure packs
Two or more goods (including at least one medical device) are a
system or procedure pack if:
(a) all of the goods are to be interconnected or combined for use
in a medical or surgical procedure; or
(b) all of the goods are packaged together for use in a medical or
surgical procedure.
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Medical devices Schedule 1
Basis of certification of conformity assessment procedures Part 2
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Part 2—Basis of certification of conformity assessment procedures
Therapeutic Goods Act 1989
19 Section 41FDA
Before “When”, insert “(1)”.
20 At the end of section 41FDA
Add:
(2) However, subsection (1) does not apply if devices of the kind in
question are class I medical devices (within the meaning of
regulations made for the purposes of this Chapter).
21 Application provision
The amendments made by this Part apply in relation to an application
made under section 41FC of the Therapeutic Goods Act 1989 on or after
the commencement of this item.
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Schedule 1 Medical devices
Part 3 Cancellation of entries of kinds of medical devices from the Register
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Part 3—Cancellation of entries of kinds of medical devices from the Register
Therapeutic Goods Act 1989
22 After paragraph 41GL(c)
Insert:
(ca) the kind of medical device is covered by an exemption under
paragraph 41HA(1)(b); or
23 Application provision
The amendment made by this Part applies in relation to a kind of
medical device included in the Register before, on or after the
commencement of this item.
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Medical device standards and conformity assessment standards Part 4
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Part 4—Medical device standards and conformity assessment standards
Therapeutic Goods Act 1989
24 At the end of section 41CB
Add:
(3) 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.
25 At the end of section 41DC
Add:
(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.
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Schedule 2 Scientific advice about quality, safety and efficacy of medicine
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Schedule 2—Scientific advice about quality, safety and efficacy of medicine
Therapeutic Goods Act 1989
1 After Division 1A of Part 3-2
Insert:
Division 1B—Scientific advice about aspects of quality,
safety or efficacy of medicine
22G Scientific advice about aspects of quality, safety or efficacy of
medicine
Requests about aspects of the quality of medicine
(1) A person may request the Secretary for advice about whether, if the
person were to make an application under section 23 for
registration of a medicine, a prescribed aspect of the quality of the
medicine, for the purposes identified by the person as purposes for
which the medicine may be used, has been satisfactorily
established.
(2) Each request under subsection (1) must relate only to one aspect of
the quality of the medicine.
Requests about aspects of the safety of medicine
(3) A person may request the Secretary for advice about whether, if the
person were to make an application under section 23 for
registration of a medicine, a prescribed aspect of the safety of the
medicine, for the purposes identified by the person as purposes for
which the medicine may be used, has been satisfactorily
established.
(4) Each request under subsection (3) must relate only to one aspect of
the safety of the medicine.
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Requests about aspects of the efficacy of medicine
(5) A person may request the Secretary for advice about whether, if the
person were to make an application under section 23 for
registration of a medicine, a prescribed aspect of the efficacy of the
medicine, for the purposes identified by the person as purposes for
which the medicine may be used, has been satisfactorily
established.
(6) Each request under subsection (5) must relate only to one aspect of
the efficacy of the medicine.
Secretary must give advice
(7) The Secretary must give advice in response to a request under this
section that is made in accordance with this section.
How request is to be made
(8) A request under this section:
(a) must be made in accordance with a form approved, in
writing, by the Secretary; and
(b) must be accompanied by the fee prescribed by the
regulations; and
(c) may be accompanied by any information or documents the
person making the request considers appropriate.
(9) An approval of a form may require or permit a request, information
or a document 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.
2 After subsection 25(2)
Insert:
(2AA) If:
(a) the applicant is applying for the registration of a medicine;
and
(b) the Secretary has given the applicant or any other person
advice under section 22G in relation to the medicine;
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the Secretary must have regard to the advice in evaluating the
medicine under this section.
(2AB) Subsection (2AA) does not limit the matters the Secretary may take
into account in evaluating the medicine under this section.
3 Before paragraph 60(1A)(aa)
Insert:
(aaa) the giving of advice under section 22G;
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Schedule 3—Variations to approved clinical trials
Therapeutic Goods Act 1989
1 At the end of subsection 19(1)
Add:
Note: For variation of an approval for use of the kind referred to in
paragraph (1)(b), see subsection (4B).
2 Subparagraph 19(2)(b)(i)
Repeal the subparagraph, substitute:
(i) be in a form (if any) approved, in writing, by the
Secretary; and
3 After subsection 19(4A)
Insert:
(4B) If:
(a) the Secretary grants an approval to a person under
subsection (1) for use of the kind referred to in
paragraph (1)(b); and
(b) the person requests the Secretary to do either or both of the
following:
(i) vary the therapeutic goods specified in the approval;
(ii) vary the conditions imposed under subsection (1) on the
approval; and
(c) the request is in a form (if any) approved, in writing, by the
Secretary; and
(d) the request is accompanied by such information relating to
the therapeutic goods as is required by the Secretary; and
(e) the request is accompanied by the fee prescribed by the
regulations;
the Secretary must, by notice in writing, vary or refuse to vary the
approval. Any variation may be different than the variation
requested and may involve imposing new conditions on the
approval or varying or removing existing conditions.
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(4C) The Secretary must notify the person making the request under
subsection (4B) of:
(a) the Secretary’s decision on the request; and
(b) for a decision to vary the approval in a way that is different
than the variation requested or a decision to refuse to vary the
approval—the reasons for the decision.
(4D) A variation under subsection (4B) takes effect at the time the
Secretary notifies the person under subsection (4C) of the
variation.
4 At the end of subsection 32CK(1)
Add:
Note: For variation of an approval for use of the kind referred to in
paragraph (1)(e), see subsection (9A).
5 Paragraph 32CK(4)(b)
Repeal the paragraph, substitute:
(b) be in a form (if any) approved, in writing, by the Secretary;
and
6 After subsection 32CK(9)
Insert:
Varying approval for use solely for experimental purposes in
humans
(9A) If:
(a) the Secretary grants an approval to a person under
subsection (1) for use of the kind referred to in
paragraph (1)(e); and
(b) the person requests the Secretary to do either or both of the
following:
(i) vary the biological specified in the approval;
(ii) vary the conditions imposed under subsection (6) on the
approval; and
(c) the request is in a form (if any) approved, in writing, by the
Secretary; and
(d) the request is accompanied by such information relating to
the biological as is required by the Secretary; and
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(e) the request is accompanied by the fee prescribed by the
regulations;
the Secretary must, by notice in writing, vary or refuse to vary the
approval. Any variation may be different than the variation
requested and may involve imposing new conditions on the
approval or varying or removing existing conditions.
(9B) The Secretary must notify the person making the request under
subsection (9A) of:
(a) the Secretary’s decision on the request; and
(b) for a decision to vary the approval in a way that is different
than the variation requested or a decision to refuse to vary the
approval—the reasons for the decision.
(9C) A variation under subsection (9A) takes effect at the time the
Secretary notifies the person under subsection (9B) of the
variation.
7 At the end of subsection 41HB(1)
Add:
Note: For variation of an approval for use of the kind referred to in
paragraph (1)(e), see subsection (8).
8 Paragraph 41HB(5)(a)
Repeal the paragraph, substitute:
(a) be in a form (if any) approved, in writing, by the Secretary;
and
9 At the end of section 41HB
Add:
Varying approval for use solely for experimental purposes in
humans
(8) If:
(a) the Secretary grants an approval to a person under
subsection (1) for use of the kind referred to in
paragraph (1)(e); and
(b) the person requests the Secretary to do either or both of the
following:
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(i) vary the medical device or kind of medical device
specified in the approval;
(ii) vary the conditions imposed under subsection (2) on the
approval; and
(c) the request is in a form (if any) approved, in writing, by the
Secretary; and
(d) the request is accompanied by such information relating to
the medical device or kind of medical device as is required
by the Secretary; and
(e) the request is accompanied by the fee prescribed by the
regulations;
the Secretary must, by notice in writing, vary or refuse to vary the
approval. Any variation may be different than the variation
requested and may involve imposing new conditions on the
approval or varying or removing existing conditions.
(9) The Secretary must notify the person making the request under
subsection (8) of:
(a) the Secretary’s decision on the request; and
(b) for a decision to vary the approval in a way that is different
than the variation requested or a decision to refuse to vary the
approval—the reasons for the decision.
(10) A variation under subsection (8) takes effect at the time the
Secretary notifies the person under subsection (9) of the variation.
10 Application provisions
(1) Paragraph 19(4B)(a) of the Therapeutic Goods Act 1989, as inserted by
this Schedule, applies in relation to an approval granted before, on or
after the commencement of this item.
(2) Paragraph 32CK(9A)(a) of the Therapeutic Goods Act 1989, as inserted
by this Schedule, applies in relation to an approval granted before, on or
after the commencement of this item.
(3) Paragraph 41HB(8)(a) of the Therapeutic Goods Act 1989, as added by
this Schedule, applies in relation to an approval granted before, on or
after the commencement of this item.
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Schedule 4—Preliminary assessment of applications for variation of permissible ingredients determination
Therapeutic Goods Act 1989
1 Subsection 3(1) (after paragraph (b) of the definition of passed preliminary assessment)
Insert:
(ba) when used in relation to a section 26BD application—has the
meaning given by subsection 26BD(4); and
2 After section 26BC
Insert:
26BD Requirements relating to an application for variation of a
section 26BB determination
(1) A person may make an application to the Secretary for a
recommendation by the Secretary that the Minister vary a
section 26BB determination.
(2) If such an application is made, the Secretary must carry out an
assessment of whether the requirements set out in subsection (3)
have been met in relation to the application.
(3) The requirements are as follows:
(a) the application must be made in accordance with a form
approved, in writing, by the Secretary;
(b) the application must set out the recommendation sought;
(c) the prescribed application fee must be paid;
(d) the application must be delivered to an office of the
Department specified in the form;
(e) the application must be accompanied by information that is:
(i) of a kind determined under subsection (8); and
(ii) in a form determined under subsection (9).
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Passing preliminary assessment
(4) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (2), in
relation to the application; and
(b) is satisfied that the requirements set out in subsection (3)
have been met in relation to the application.
(5) 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.
(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) An approval of a form mentioned in paragraph (3)(a) 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
(8) The Secretary may, by legislative instrument, determine a kind of
information for the purposes of subparagraph (3)(e)(i).
(9) The Secretary may, by legislative instrument, determine a form of
information for the purposes of subparagraph (3)(e)(ii).
26BDA Lapsing of application for variation of a section 26BB
determination
If an application made under subsection 26BD(1) has passed
preliminary assessment, the application 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.
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3 Section 26BE (heading)
Repeal the heading, substitute:
26BE Evaluation of whether to make recommendation for variation
of a section 26BB determination
4 Subsections 26BE(1) to (2B)
Repeal the subsections.
5 Paragraph 26BE(3)(a)
Repeal the paragraph, substitute:
(a) an application is made under subsection 26BD(1) for a
recommendation by the Secretary that the Minister vary a
section 26BB determination; and
(aa) the application has passed preliminary assessment; and
6 Paragraph 26BE(3)(c)
Omit “subsection (2A)”, substitute “subsection (3A)”.
7 After subsection 26BE(3)
Insert:
(3A) The Secretary may, by written notice given to a person who has
made an application under subsection 26BD(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.
8 Subsection 26BE(5B) (heading)
Omit “application”, substitute “evaluation”.
9 Paragraph 26BE(5B)(a)
Repeal the paragraph, substitute:
(a) an evaluation fee is prescribed for the purposes of
paragraph (3)(b); and
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10 Paragraph 26BE(5B)(c)
Omit “subsection (1)”, substitute “subsection 26BD(1)”.
11 Subsection 26BE(5B)
Omit “the application fee”, substitute “the evaluation fee”.
12 Paragraph 26BE(5C)(b)
Omit “subsection (1)”, substitute “subsection 26BD(1)”.
13 Subsection 26BE(9)
Repeal the subsection, substitute:
Information may be given electronically
(9) A notice mentioned in subsection (3A) 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.
14 Paragraph 60(1A)(aa)
After “23B,”, insert “26BD,”.
15 Subsection 60(2B)
Omit “subsection 26BE(1)”, substitute “subsection 26BD(1)”.
16 Application, saving and transitional provisions
(1) The amendments made by this Schedule apply in relation to an
application made under subsection 26BD(1) of the Therapeutic Goods
Act 1989 on or after the commencement of this item.
(2) Section 26BE and subsection 60(2B) of the Therapeutic Goods Act
1989, as in force immediately before the commencement of this item,
continue to apply on and after that commencement in relation to an
application made under subsection 26BE(1) of that Act before that
commencement.
(3) An approved form that was in effect immediately before the
commencement of this item for the purposes of paragraph 26BE(2)(a)
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of the Therapeutic Goods Act 1989 continues in force on and after that
commencement as if it were an approved form in effect for the purposes
of paragraph 26BD(3)(a) of that Act.
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Schedule 5—Approving supply of therapeutic goods under authorised prescriber scheme
Therapeutic Goods Act 1989
1 Subsection 19(6)
Omit “exceptional”.
2 Subsection 32CM(4)
Omit “exceptional”.
3 Subsection 41HC(4)
Omit “exceptional”.
4 Application and transitional provisions
(1) The amendment of subsection 19(6) of the Therapeutic Goods Act 1989
made by this Schedule applies in relation to an authority given under
subsection 19(5) of that Act on or after the commencement of this item.
(2) Regulations made for the purposes of subsection 19(6) of the
Therapeutic Goods Act 1989 that are in force immediately before the
commencement of this item are taken, on and after that commencement,
to have been made for the purposes of that subsection as amended by
this Schedule.
(3) The amendment of subsection 32CM(4) of the Therapeutic Goods Act
1989 made by this Schedule applies in relation to an authority given
under subsection 32CM(1) of that Act on or after the commencement of
this item.
(4) Regulations made for the purposes of subsection 32CM(4) of the
Therapeutic Goods Act 1989 that are in force immediately before the
commencement of this item are taken, on and after that commencement,
to have been made for the purposes of that subsection as amended by
this Schedule.
(5) The amendment of subsection 41HC(4) of the Therapeutic Goods Act
1989 made by this Schedule applies in relation to an authority given
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under subsection 41HC(1) of that Act on or after the commencement of
this item.
(6) Regulations made for the purposes of subsection 41HC(4) of the
Therapeutic Goods Act 1989 that are in force immediately before the
commencement of this item are taken, on and after that commencement,
to have been made for the purposes of that subsection as amended by
this Schedule.
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Schedule 6—Removal of offences for person claiming to be able to arrange supply of therapeutic goods
Therapeutic Goods Act 1989
1 Subsection 22(6)
Repeal the subsection.
2 Subsection 32BJ(4)
Repeal the subsection.
3 Section 41MM
Repeal the section.
4 Saving provisions
(1) Despite the repeal of subsection 22(6) of the Therapeutic Goods Act
1989 made by this Schedule, that subsection, as in force immediately
before the commencement of this item, continues to apply on and after
that commencement in relation to claims made before that
commencement.
(2) Despite the repeal of subsection 32BJ(4) of the Therapeutic Goods Act
1989 made by this Schedule, that subsection, as in force immediately
before the commencement of this item, continues to apply on and after
that commencement in relation to claims made before that
commencement.
(3) Despite the repeal of section 41MM of the Therapeutic Goods Act 1989
made by this Schedule, that section, as in force immediately before the
commencement of this item, continues to apply on and after that
commencement in relation to claims made before that commencement.
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Schedule 7—Conditions of registration or listing of therapeutic goods
Therapeutic Goods Act 1989
1 Before paragraph 28(5)(aa)
Insert:
(aaa) if:
(i) the person proposes to make a change to the information
included in the entry in the Register that relates to the
subject goods; and
(ii) the information proposed to be changed is of a kind that
relates to one or more of the matters referred to in
paragraphs 25(1)(c) to (ja), 26(1)(c) to (n), 26A(2)(a) to
(ja) or 26AB(2)(a) to (p) (as appropriate); and
(iii) the Secretary would be required, under section 9D, to
vary that entry, or to consider whether to vary that entry,
in relation to the information proposed to be changed if
the person made a request under that section for a
variation of that entry;
make that request and not make the change unless the
Secretary varies that entry in accordance with that request;
and
2 Application provision
The amendment made by this Schedule applies on and after the
commencement of this item in relation to therapeutic goods included in
the Register before, on or after that commencement.
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Schedule 8—Changes to provisionally registered medicine
Therapeutic Goods Act 1989
1 Section 23AA
Before “If”, insert “(1)”.
2 At the end of section 23AA
Add:
(2) If:
(a) in accordance with subsection 29(2), a medicine (the original
medicine) is provisionally registered because of an
application by a person that, under subsection (1) of this
section, is taken to be an application for provisional
registration of the original medicine; and
(b) another medicine (the new medicine) is taken, under
subsection 16(1), to be separate and distinct from the original
medicine; and
(c) the person makes an application under section 23 for the
registration of the new medicine; and
(d) the person makes the application before the end of the
provisional registration period for the original medicine
under subsection 29(3) (including that period as extended
under subsection 29(6)); and
(e) the person specifies in the application that the person is
seeking provisional registration of the new medicine; and
(f) at the time the person makes the application, the active
ingredients of the new medicine are the same as the active
ingredients of the original medicine; and
(g) at the time the person makes the application, the indications
of the new medicine are the same as the indications of the
original medicine;
then, for the purposes of this Act, the application is taken to be an
application for provisional registration of the new medicine.
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3 Subparagraph 25(1)(d)(iii)
Before “whether”, insert “if subsection 23AA(1) applies in relation to
the application—”.
4 Subsection 29(3)
Repeal the subsection, substitute:
(3) Subject to this section, the provisional registration period, for a
medicine that is provisionally registered because of an application
that, under subsection 23AA(1), is taken to be an application for
provisional registration of the medicine, is the period of 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.
(3A) Subject to this section, the provisional registration period, for a
medicine (the new medicine) that is provisionally registered
because of an application that, under subsection 23AA(2), is taken
to be an application for provisional registration of the new
medicine, is as follows:
(a) if, in relation to the new medicine, the day (the start day)
referred to in subsection 25AB(6) occurs in the period (the
original period) referred to in subsection (3) of this section in
relation to the original medicine concerned—the period
starting on the start day and ending at the end of the original
period;
(b) if, in relation to the new medicine, the start day occurs in a
period of extension of the original period that is granted
under subsection (6)—the period starting on the start day and
ending at the end of that extension period.
Note: Subsection 25AB(6) provides that registration commences on the day
specified in the certificate of registration.
5 Paragraph 29(5)(c)
Repeal the paragraph, substitute:
(c) be made:
(i) if the medicine is provisionally registered because of an
application that, under subsection 23AA(1), was taken
to be an application for provisional registration of the
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medicine—at least 6 months before the provisional
registration of the medicine is due to end; or
(ii) if the medicine is provisionally registered because of an
application that, under subsection 23AA(2), was taken
to be an application for provisional registration of the
medicine—at least 1 month before the provisional
registration of the medicine is due to end; and
6 Subsection 29(6)
Repeal the subsection, substitute:
(6) If:
(a) a person makes an application under subsection (4) in
accordance with this section; and
(b) the medicine is provisionally registered because of an
application that, under subsection 23AA(1), was taken to be
an application for provisional registration of the medicine;
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:
(c) 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
(d) such other matters (if any) as the Secretary considers
relevant.
(6A) If:
(a) a person makes an application under subsection (4) in
accordance with this section; and
(b) the medicine is provisionally registered because of an
application that, under subsection 23AA(2), was taken to be
an application for provisional registration of the medicine;
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 such matters as the
Secretary considers relevant.
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7 Subsection 29(7)
Omit “after making the decision”, substitute “after making a decision
under subsection (6) or (6A)”.
8 Subsection 29(8)
After “granted”, insert “in relation to a medicine”.
9 After subsection 29(8)
Insert:
(8A) The Secretary must not, under subsection (6A), extend the
provisional registration period applicable under subsection (3A) for
the new medicine so that period would end more than 6 years after
the provisional registration for the original medicine concerned
commenced.
10 Paragraph 60(2D)(a)
After “subsection 29(6)”, insert “or (6A)”.
11 Application, saving and transitional provisions
(1) Paragraph 23AA(2)(a) of the Therapeutic Goods Act 1989, as added by
this Schedule, applies in relation to a medicine provisionally registered
before, on or after the commencement of this item.
(2) Paragraph 23AA(2)(d) of the Therapeutic Goods Act 1989, as added by
this Schedule, applies in relation to an application made on or after the
commencement of this item.
(3) The amendment of subparagraph 25(1)(d)(iii) of the Therapeutic Goods
Act 1989 made by this Schedule applies in relation to an application for
provisional registration of a medicine that is made on or after the
commencement of this item.
(4) Subsections 29(3) and (3A) of the Therapeutic Goods Act 1989, as
substituted by this Schedule, apply in relation to an application for
provisional registration of a medicine that is made on or after the
commencement of this item.
(5) The repeal and substitution of paragraph 29(5)(c) of the Therapeutic
Goods Act 1989 made by this Schedule applies in relation to an
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application made under subsection 29(4) of that Act on or after the
commencement of this item.
(6) Subsections 29(6) and (6A) of the Therapeutic Goods Act 1989, as
substituted by this Schedule, apply in relation to an application made
under subsection 29(4) of that Act on or after the commencement of this
item.
(7) The repeal of subsection 29(6) of the Therapeutic Goods Act 1989 made
by this Schedule does not affect the validity of a decision made under
that subsection before the commencement of this item.
(8) If, before the commencement of this item, an application was taken,
under section 23AA of the Therapeutic Goods Act 1989, to be an
application for provisional registration of a medicine, then, on and after
that commencement, the application is to be treated as if it was taken,
under subsection 23AA(1) of that Act, to be an application for
provisional registration of the medicine.
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Schedule 9—Data protection for certain listed medicine
Therapeutic Goods Act 1989
1 Subsection 3(1)
Insert:
restricted information has the meaning given by section 26AF.
2 At the end of subsection 26AE(1)
Add:
Note: The Secretary must not use restricted information when evaluating the
medicine for listing: see section 26AF.
3 After section 26AE
Insert:
26AF When the Secretary must not use restricted information in
evaluating medicine for listing under section 26AE
(1) If an application is made under section 23 for the listing of a
medicine under section 26AE, then, in evaluating the medicine
under section 26AE, the Secretary must not use information about
other medicine that is restricted information.
(2) Information is restricted information if:
(a) the information was given to the Secretary in relation to an
application made under section 23 for the listing of a
medicine (the existing medicine) under section 26AE; and
(b) the information is derived from a clinical trial in relation to
an indication of the existing medicine, being an indication
that is not covered by a determination under
paragraph 26BF(1)(a); and
(c) the information is not available to the public; and
(d) at the time the application to list the existing medicine was
made:
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(i) no other medicine with that indication was included in
the Register; and
(ii) no other medicine with that indication had been
included in the Register at any time before that time;
and
(e) the existing medicine was listed under section 26AE on or
after the commencement of this subsection; and
(f) 5 years have not passed since the day that listing
commenced; and
(g) the person in relation to whom the existing medicine is listed
has not given the Secretary permission in writing for the
Secretary to use the information.
4 After subsection 30(4A)
Insert:
(4B) The Secretary must, 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 the Secretary becomes aware that
restricted information was used when evaluating the medicine for
listing.
5 Subsection 61(8)
Omit “section 25A”, substitute “sections 25A and 26AF”.
6 Application provisions
(1) Subsection 26AF(1) of the Therapeutic Goods Act 1989, as inserted by
this Schedule, applies in relation to an application made on or after the
commencement of this item.
(2) Subsection 30(4B) of the Therapeutic Goods Act 1989, as inserted by
this Schedule, applies in relation to a medicine listed on or after the
commencement of this item, where the application for the listing was
made on or after that commencement.
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Schedule 10—Other amendments
Patents Act 1990
1 Subparagraph 119A(1)(a)(ii)
Omit “, or therapeutic devices,”.
Therapeutic Goods Act 1989
2 Subsection 3(1)
Insert:
Australia-UK Mutual Recognition Agreement means the
Agreement on Mutual Recognition in Relation to Conformity
Assessment, Certificates And Markings between the Government
of Australia and the Government of the United Kingdom of Great
Britain and Northern Ireland, as in force from time to time.
Note: The Agreement could in 2020 be viewed in the Australian Treaties
Library on the AustLII website (http://www.austlii.edu.au).
3 Subsection 3(1) (definition of gazetted therapeutic devices group)
Repeal the definition.
4 Subsection 3(1) (paragraph (b) of the definition of grouped therapeutic goods)
Repeal the paragraph.
5 Subsection 3(1) (note to the definition of included in the Register)
Repeal the note.
6 Subsection 3(1) (definition of listable devices)
Repeal the definition.
7 Subsection 3(1) (definition of medicine)
Repeal the definition, substitute:
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medicine means 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.
8 Subsection 3(1) (definition of therapeutic device)
Repeal the definition.
9 Paragraph 7B(2)(b)
Omit “or therapeutic devices”.
10 Section 9B
Repeal the section.
11 Chapter 3 (note to Chapter heading)
Repeal the note.
12 Section 10A
Repeal the section.
13 Section 15A
Repeal the section, substitute:
15A Part does not apply to a medical device
This Part does not apply to a medical device.
Note: Chapter 4 deals with medical devices.
14 Subsection 16(2)
Omit “or therapeutic devices”.
15 Subsection 16(3)
Repeal the subsection.
16 Subsection 16(4)
Omit “, (3)”.
17 Section 19 (heading)
Repeal the heading, substitute:
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19 Approvals or authorities for certain uses
18 Section 19A (heading)
Repeal the heading, substitute:
19A Approvals where unavailability etc. of therapeutic goods
19 Paragraph 19D(3)(a)
Omit “(other than listed goods that are therapeutic devices)”.
20 Paragraph 19D(4)(a)
Omit “(other than listed goods that are therapeutic devices)”.
21 Section 21
Omit “(other than listable devices)”.
22 Section 23A
Before “The”, insert “(1)”.
23 At the end of section 23A
Add:
(2) Without limiting subsection (1), a class of therapeutic goods may
be specified by reference to one or more of the matters referred to
in paragraphs 16(1)(a) to (g) or 16(1A)(a) to (d).
24 Transitional provision
An instrument in force immediately before the commencement of this
item under section 23A of the Therapeutic Goods Act 1989 continues in
force on and after that commencement as if it were an instrument made
under subsection 23A(1) of that Act.
25 Subsection 23C(2) (note)
Omit “26AA,”.
26 Subparagraphs 25(2)(a)(i) and (ia)
Omit “the goods are not therapeutic devices and”.
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27 Subsection 25AB(1)
Repeal the subsection.
28 Subsection 25AB(2) (heading)
Repeal the heading.
29 Paragraph 25AB(2)(b)
Omit “and”.
30 Paragraph 25AB(2)(c)
Repeal the paragraph.
31 Paragraph 25A(2)(a)
Repeal the paragraph, substitute:
(a) the information was given to the Secretary in relation to an
application to register therapeutic goods (the new goods)
consisting of, or containing, an active component; and
32 Section 25B
Repeal the section.
33 Paragraph 26(1)(aa)
Omit “if goods are not therapeutic devices—”.
34 Subsection 26(1)
Omit “and section 26AA”.
35 Paragraph 26(1)(g)
Omit “(not being therapeutic devices other than devices prescribed for
the purposes of this paragraph)”.
36 Subparagraphs 26(2)(a)(i) and (ia)
Omit “the goods are not therapeutic devices and”.
37 Section 26AA
Repeal the section.
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38 Section 32CM (heading)
Repeal the heading, substitute:
32CM Authorities for health practitioners
39 Section 33A
Repeal the section, substitute:
33A Part does not apply to a medical device
This Part does not apply to a medical device.
Note: Chapter 4 deals with medical devices.
40 Chapter 4 (note to Chapter heading)
Repeal the note.
41 Section 41BJ
Repeal the section.
42 Section 41HC (heading)
Repeal the heading, substitute:
41HC Authorities for health practitioners
43 Paragraph 46A(4)(b)
Omit “registration or listing of the therapeutic goods”, substitute
“registration, listing or inclusion”.
44 Section 52EB
Repeal the section.
45 Subsection 60(1) (paragraph (a) of the definition of initial decision)
Omit “under the definition of therapeutic devices in subsection 3(1)
or”.
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46 Subsection 60(1) (paragraph (c) of the definition of initial decision)
After “goods)”, insert “, other than a decision under
paragraph 26BE(4)(a), or a decision under subsection 26BJ(8), to make
a recommendation”.
47 Application provision
The amendment made by item 46 applies in relation to a decision made
on or after the commencement of this item.
48 Paragraph 60(2AB)(c)
Repeal the paragraph.
49 Subsection 61(1) (definition of therapeutic goods information)
Omit “or the EFTA Mutual Recognition Agreement”, substitute “, the
EFTA Mutual Recognition Agreement or the Australia-UK Mutual
Recognition Agreement”.
[Minister’s second reading speech made in—
House of Representatives on 4 March 2020
Senate on 17 June 2020]
(23/20)
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