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This is a Bill, not an Act. For current law, see the Acts databases.
2002-2003
The Parliament of
the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
As read a third
time
Therapeutic
Goods Amendment Bill (No. 1) 2003
No.
, 2003
A Bill for an Act to
amend the Therapeutic Goods Act 1989, and for related
purposes
Contents
Part 1—Definition of therapeutic
goods 4
Part 2—Advertising of therapeutic
goods 5
Part 3—Other
amendments 19
THIS Bill originated in the House of Representatives; and,
having this day passed, is now ready for presentation to the Senate for its
concurrence.
House of Representatives
14 May
2003
A Bill for an Act to amend the Therapeutic Goods Act
1989, and for related purposes
The Parliament of Australia enacts:
This Act may be cited as the Therapeutic Goods Amendment Act
(No. 1) 2003.
(1) Each provision of this Act specified in column 1 of the table
commences, or is taken to have commenced, on the day or at the time specified in
column 2 of the table.
|
Commencement information |
||
|---|---|---|
|
Column 1 |
Column 2 |
Column 3 |
|
Provision(s) |
Commencement |
Date/Details |
|
1. Sections 1 to 3 and anything in this Act not elsewhere covered by
this table |
The day on which this Act receives the Royal Assent |
|
|
2. Schedule 1, Parts 1 and 2 |
A single day to be fixed by Proclamation, subject to
subsection (3) |
|
|
3. Schedule 1, items 20 to 78 |
The day on which this Act receives the Royal Assent |
|
|
4. Schedule 1, item 79 |
Immediately after the commencement of the Health and Aged Care
Legislation Amendment (Application of Criminal Code) Act 2001 |
|
|
5. Schedule 1, item 80 |
The day on which this Act receives the Royal Assent |
|
|
6. Schedule 2 |
At the same time as the provisions covered by item 2 of this
table |
|
Note: This table relates only to the provisions of this Act
as originally passed by the Parliament and assented to. It will not be expanded
to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table is for additional information that is not part
of this Act. This information may be included in any published version of this
Act.
(3) If a provision covered by item 2 of the table does not commence
within the period of 6 months beginning on the later of:
(a) the day on which this Act receives the Royal Assent; and
(b) the day on which Schedule 1 to the Therapeutic Goods Amendment
(Medical Devices) Act 2002 commences;
it commences on the first day after the end of that period.
Each Act 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.
Part 1—Definition
of therapeutic goods
1 Subsection 3(1) (paragraph (1)(e) of the
definition of therapeutic goods)
Repeal the paragraph, substitute:
(e) goods (other than goods declared to be therapeutic goods under an
order in force under section 7) for which there is a prescribed standard in
the Australia New Zealand Food Standards Code as defined in subsection 3(1) of
the Australia New Zealand Food Authority Act 1991; or
Part 2—Advertising
of therapeutic goods
2 Subsection 3(1) (definition of Therapeutic
Goods Advertising Code)
Repeal the definition, substitute:
Therapeutic Goods Advertising Code means the Code known as
the Therapeutic Goods Advertising Code notified in the Gazette with
effect from the date of commencement of Schedule 1 to the Therapeutic
Goods Amendment Act (No. 1) 2003 together with any amendments of the
Code published by the Minister in the Gazette from time to
time.
3 Paragraphs 25(1)(f), 26(1)(f), 26A(2)(d),
30(1A)(c), 30(2)(e), 31(1)(h), 31(2)(g), 41FD(h), 41GL(h) and
41JA(1)(h)
Before “under the regulations”, insert “under
Part 5-1 or”.
4 Part 5-1 of Chapter 5
(heading)
Repeal the heading, substitute:
(1) This Part does not apply to advertisements directed exclusively
to:
(a) medical practitioners, psychologists, dentists, veterinary surgeons,
pharmacists, physiotherapists, dietitians, scientists working in medical
laboratories or nurses; or
(b) persons who are:
(i) engaged in the business of wholesaling therapeutic goods; or
(ii) purchasing officers in hospitals; or
(c) herbalists, homoeopathic practitioners, chiropractors, naturopaths,
nutritionists, practitioners of traditional Chinese medicine, podiatrists or
osteopaths registered under a law of a State or Territory.
(2) This Part does not apply to advertisements directed exclusively to
persons who are members of an Australian branch (however described) of one of
the bodies prescribed for the purposes of this subsection.
(3) For the purposes of subsection (2), a person is taken to be a
member of an Australian branch of one of those bodies if, and only if, the
person has the qualifications and training that are necessary or appropriate for
membership of the relevant body.
(4) This Part does not apply to advice or information given directly to a
patient by a person referred to in paragraph (1)(a) or (c) or
subsection (2) in the course of treatment of that patient.
This Part does not apply to advertisements in respect of goods that are
not for use in humans.
(1) Subject to subsection (2), this Part does not apply to
advertisements solely for therapeutic goods that have been exported or are
intended exclusively for export.
(2) Section 42DC applies to advertisements of that kind.
5 Section 42A
Repeal the section.
6 Section 42B
Insert:
broadcaster, in relation to an advertisement for therapeutic
goods, means a person (other than a person who is required to enter those goods
on the Register) who undertakes, as a business activity in its own
right:
(a) the broadcasting of the advertisement in broadcast media; or
(b) the placement of the advertisement for such broadcasting.
7 Section 42B
Insert:
broadcast media, in relation to an advertisement or generic
information, means any means (other than a means declared in the regulations to
be an exempted means) by which the information is disseminated electronically in
a visible or audible form or a combination of such forms.
8 Section 42B
Insert:
generic information, in relation to therapeutic goods,
includes any statement, pictorial representation or design, however made, about
the composition, properties or other characteristics of therapeutic goods, but
does not include:
(a) an advertisement about the goods; or
(b) generic information included in an advertisement about the goods;
or
(c) bona fide news.
9 Section 42B
Insert:
prohibited representation means a representation referred to
in subsection 42DJ(1).
10 Section 42B (definition of
publisher)
Repeal the definition, substitute:
publisher, in relation to an advertisement for therapeutic
goods, means a person (other than a person who is required to enter those goods
on the Register) who undertakes, as a business activity in its own
right:
(a) the publishing of the advertisement in specified media other than
broadcast media; or
(b) the placement of the advertisement for such publication.
11 Section 42B
Insert:
publishing, in relation to an advertisement, includes
inserting material within the pages of an item of mainstream media.
12 Section 42B
Insert:
required representation means a representation referred to in
subsection 42DJ(2).
13 Section 42B
Insert:
restricted representation means a representation referred to
in subsection 42DD(1).
14 Section 42B
Insert:
specified media, in relation to an
advertisement or generic information, means:
(a) mainstream media; or
(b) broadcast media; or
(c) cinematograph films; or
(d) displays about goods, including posters:
(i) in shopping malls (except inside an individual shop); and
(ii) in or on public transport; and
(iii) on billboards.
15 Section 42B
Insert:
visual broadcast media means broadcast media that is intended
to be viewed by its audience.
16 After section 42B
Insert:
This Division applies only to advertisements to which Part 2 of the
Therapeutic Goods Regulations applies.
17 Sections 42C and 42D
Repeal the sections, substitute:
(1) A person is guilty of an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
in specified media, an advertisement that is required by the Therapeutic
Goods Regulations to be an approved advertisement; and
(b) the advertisement is not an approved advertisement.
Penalty: 60 penalty units.
(2) A person is guilty of an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
an advertisement in specified media; and
(b) the advertisement is not an approved advertisement in that it differs,
in any respect, from the advertisement that was approved.
Penalty: 60 penalty units.
(3) It is a defence to a prosecution under subsection (2)
if:
(a) the person prosecuted is a publisher or broadcaster who received the
advertisement to which the prosecution relates for publication or broadcasting
in specified media in the ordinary course of business; or
(b) the particular advertisement to which the prosecution relates differs
only in respect of a matter mentioned in paragraph 5C(2)(b), (e) or (f) of the
Therapeutic Goods Regulations.
Note: A defendant bears an evidential burden in relation to
the matters in subsection (3) (see subsection 13.3 of the Criminal
Code).
(4) A person is guilty of an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
in specified media referred to in paragraph (a), (c) or (d) of the
definition of specified media, or in visual broadcast
media, a particular advertisement; and
(b) the advertisement:
(i) does not display its approval number; or
(ii) displays a number purporting to be its approval number but that is
not its approval number; or
(iii) displays an approval number that has expired.
Penalty: 30 penalty units.
(5) It is a defence to a prosecution under subsection (4) if the
person prosecuted:
(a) is a publisher who received the advertisement to which the prosecution
relates for publication in specified media referred to in paragraph (a),
(c) or (d) of the definition of specified media; or
(b) is a broadcaster who received the advertisement to which the
prosecution relates for broadcasting in visual broadcast media;
in the ordinary course of business.
Note: A defendant bears an evidential burden in relation to
the matters in subsection (5) (see subsection 13.3 of the Criminal
Code).
(6) A person is guilty of an offence if:
(a) the person:
(i) publishes or broadcasts; or
(ii) causes to be published or broadcast;
in specified media, an approved advertisement; and
(b) the person’s action is in contravention of a condition to which
the approval of the advertisement is subject.
Penalty: 60 penalty units.
(7) It is a defence to a prosecution under subsection (6) if the
person prosecuted is a publisher or broadcaster who received the advertisement
to which the prosecution relates for publication or broadcasting in specified
media in the ordinary course of business.
Note: A defendant bears an evidential burden in relation to
the matters in subsection (7) (see subsection 13.3 of the Criminal
Code).
(8) An offence against this section is an offence of strict
liability.
18 At the end of Part 5-1 of
Chapter 5
Add:
This Division applies to advertisements about therapeutic goods other
than advertisements for which an approval is required under Part 2 of the
Therapeutic Goods Regulations.
In this Division:
applicant means an applicant for approval of the use of a
restricted representation in an advertisement about therapeutic goods.
approval holder, in relation to a restricted representation,
means the person to whom notice of approval of the use of the restricted
representation was given.
If a representation in an advertisement about therapeutic goods is false
or misleading, the Secretary may, by notice given to the person apparently
responsible for publishing or broadcasting the advertisement, prevent that
person from publishing or broadcasting, or causing to be published or broadcast,
an advertisement containing that representation (whether express or implied)
about those goods.
(1) For the purposes of this Part, a representation in an advertisement
about therapeutic goods that refers to a serious form of a disease, condition,
ailment or defect specified in a part of the Therapeutic Goods Advertising Code
that is prescribed by the regulations for the purposes of this subsection is a
restricted representation about therapeutic goods.
(2) A person must not use a restricted representation in an advertisement
about therapeutic goods unless the Secretary:
(a) has approved its use under subsection 42DF(1); or
(b) has permitted its use under subsection 42DK(1).
An application for approval of the use of a restricted representation
must be:
(a) made to the Secretary in writing, in a form approved by the Secretary;
and
(b) signed by or on behalf of the applicant.
(1) If an application for approval of the use of a restricted
representation is made, the Secretary must approve the use of the restricted
representation if the Secretary is satisfied that:
(a) the representation is accurate and balanced; and
(b) the representation is not misleading or likely to be
misleading.
(2) Otherwise, the Secretary must refuse to approve the use of the
restricted representation.
(3) An approval may be subject to conditions imposed by the
Secretary.
(4) In deciding whether to approve or refuse to approve the use of a
restricted representation, the Secretary must take into consideration:
(a) any recommendation of the Therapeutic Goods Advertising Code Council;
and
(b) any advice of the Complementary Medicines Evaluation Committee or the
Medicines Evaluation Committee; and
(c) the public interest criteria mentioned in a part of the Therapeutic
Goods Advertising Code that is prescribed by the regulations made for the
purposes of this paragraph.
(1) The Secretary must give written notice to the applicant of the
approval of, or of the refusal to approve, the use of a restricted
representation.
(2) If written notice is not given to the applicant within the period of
60 days after the day on which the application was made (or within such longer
period as the Secretary specifies by written notice to the applicant before the
end of that period), the Secretary is taken to have approved the use of the
restricted representation at the end of the period.
(3) If an approval is subject to conditions, the conditions must be set
out in the notice.
(4) A notice of refusal to approve the use of a restricted representation
must:
(a) give the Secretary’s reasons for the refusal; and
(b) inform the applicant of the applicant’s right to have the
Secretary’s decision reviewed by the Minister under
section 60.
(1) The Secretary, by written notice to an approval holder, may vary any
condition of approval of the use of a restricted representation.
(2) The notice must:
(a) give the Secretary’s reasons for the variation; and
(b) inform the approval holder of the approval holder’s right to
have the Secretary’s decision reviewed by the Minister under
section 60.
(1) The Secretary, by written notice, may withdraw the approval of the use
of a restricted representation if:
(a) the Secretary is satisfied that:
(i) information given by the applicant in the application was false or
incorrect and the Secretary, or the Minister on review of a decision of the
Secretary under section 42DF or 42DH, relied on the information in deciding
to approve the use of the representation; or
(ii) the restricted representation has become a prohibited representation;
or
(iii) there has been a breach of a condition of approval; or
(b) both:
(i) additional information about the safety of the therapeutic goods
becomes available; and
(ii) the Secretary is satisfied that, if that information had been
available at the time of the approval, the Secretary would not have approved the
use of the restricted representation.
(2) The notice must:
(a) give the Secretary’s reasons for the withdrawal; and
(b) inform the approval holder of the approval holder’s right to
have the Secretary’s decision reviewed by the Minister under
section 60.
(1) For the purposes of this Part, representations of a kind specified in
regulations made for the purposes of this subsection are prohibited
representations about therapeutic goods of a kind specified in those
regulations.
(2) For the purposes of this Part, representations of a kind specified in
regulations made for the purposes of this subsection are required
representations about the therapeutic goods of a kind specified in those
regulations.
(1) The Secretary may, by notice in writing published in the
Gazette or on the Department’s web site on the Internet, permit, in
relation to therapeutic goods, the use of a restricted representation (including
its use on the label of the goods or in information included in the package in
which the goods are contained).
(2) The Secretary may, by notice in writing published in the Gazette
or on the Department’s web site on the Internet, permit a prohibited
representation to be included on the label of therapeutic goods, or in
information included in the package in which therapeutic goods are contained, if
the representation is necessary for the appropriate use of the goods.
(1) A person must not publish or broadcast an advertisement about
therapeutic goods:
(a) that contains a prohibited representation (whether in express terms or
by necessary implication) about those goods; or
(b) that does not contain a required representation about those goods;
or
(c) that contains a restricted representation, about those goods, the use
of which has not been approved under subsection 42DF(1) or permitted under
subsection 42DK(1); or
(d) that is in contravention:
(i) of a notice referred to in section 42DC that was served on the
person; or
(ii) of a notice referred to in section 42DK of which the person was
aware when the advertisement was published; or
(e) that contains:
(i) a reference to the Act other than in a statement of the registration
number, listing number or device number of the goods; or
(ii) a statement suggesting or implying the goods have been recommended or
approved by or on behalf of a government or government authority (including a
foreign government or foreign government authority), other than a statement of
their availability as a pharmaceutical benefit or a statement authorised or
required by a government or government authority (including a foreign government
or foreign government authority); or
(f) that refers to goods, or substances or preparations containing goods,
included in Schedule 3, 4 or 8 to the Poisons Standard; or
(g) that are not entered in the Register; or
(h) if the goods are therapeutic goods, or come within a class of
therapeutic goods, that:
(i) are exempt goods or exempt devices prescribed in the regulations for
the purposes of this provision; or
(ii) have been approved under subsection 19(1) or section 41HB of
this Act for importation into, exportation from, or supply within,
Australia.
Penalty: 60 penalty units.
(2) For the purposes of an offence against subsection (1), strict
liability applies to the following physical elements:
(a) that the use of a restricted representation, as referred to in
paragraph (1)(c), has not been approved under subsection 42DF(1) or
permitted under subsection 42DK(1);
(b) that the notice referred to in paragraph (1)(d):
(i) in a case to which subparagraph (1)(d)(i) applies—is a
notice referred to in section 42DC; and
(ii) in a case to which subparagraph (1)(d)(ii) applies—is a
notice referred to in section 42DK;
(c) that goods, substances or preparations referred to in
paragraph (1)(f) are included in Schedule 3, 4 or 8 to the Poisons
Standard;
(d) that the therapeutic goods, or class of therapeutic goods, referred to
in paragraph (1)(h):
(i) are exempt goods or exempt devices prescribed in the regulations made
for the purposes of subparagraph (1)(h)(i); or
(ii) have been approved under subsection 19(1) or section 41HB of the
Act for importation into, exportation from or supply within,
Australia.
(3) It is a defence to a prosecution under subsection (1)
if:
(a) in relation to an advertisement mentioned in paragraph (1)(a) or
(f)—the advertisement is made by, or on behalf of, the Commonwealth;
and
(b) in relation to an advertisement mentioned in
paragraph (1)(f)—the goods, substances or preparations are mentioned
in Appendix H of the Poisons Standard; and
(c) in relation to goods mentioned in paragraph (1)(g)—the
goods are exempt goods or exempt devices other than goods of a kind mentioned in
paragraph (1)(h).
Note: A defendant bears an evidential burden in relation to
the matters mentioned in subsection (3) (see section 13.3 of the
Criminal Code).
(1) A person is guilty of an offence if:
(a) the person publishes or broadcasts an advertisement about therapeutic
goods; and
(b) the advertisement does not comply with the Therapeutic Goods
Advertising Code.
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict
liability.
This Division applies to generic information about goods that:
(a) may be used as an ingredient or component in the manufacture of
therapeutic goods; and
(b) although not presented for supply as therapeutic goods, come within
the meaning of therapeutic goods because they are represented to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of other
therapeutic goods.
Generic information to which this Division applies must comply with
principles of the Therapeutic Goods Advertising Code specified in regulations
made for the purposes of this section as if those principles applied to generic
information in the same way as they apply to advertisements.
(1) A person is guilty of an offence if:
(a) the person publishes or broadcasts generic information about
therapeutic goods; and
(b) the publication or broadcasting of that generic information does not
comply with principles contained in the part of the Therapeutic Goods
Advertising Code that are specified in Regulations.
Penalty: 60 penalty units.
(2) An offence against this section is an offence of strict
liability.
19 Subsection 60(1) (at the end of the definition of
initial decision)
Add:
; or (l) under section 42DF, 42DH or 42DI.
20 Subsection 3(1) (at the end of paragraph (b)
of the definition of authorised person)
Add “, or a Customs officer exercising powers in a Customs place
(within the meaning of section 183UA of the Customs Act
1901)”.
21 Subsection 3(1)
Insert:
Customs officer means an officer of Customs within the
meaning of the Customs Act 1901.
22 Subsection 3(5)
After “proper use”, insert “or
identification”.
23 Subsection 14(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
24 Subsection 14(3) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
25 Subsection 20(1AA)
Omit “a fine not more than 240 penalty units”, substitute
“imprisonment for 12 months or a fine not more than 1,000 penalty units,
or both”.
26 After subsection 20(1A)
Insert:
(1B) A person is guilty of 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.
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
(1C) For the purposes of paragraph (1B)(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.
27 Subsection 22(2A) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
28 Section 22A (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
29 After paragraph 25(1)(j)
Insert:
(ja) whether all of the manufacturers of the goods are nominated as
manufacturers of the goods in the application; and
30 At the end of subsection
26(1)
Add:
; or (n) one or more of the manufacturers of the goods are not nominated
as manufacturers of the goods in the application.
31 After paragraph 26A(1)(d)
Insert:
; and (e) the medicine is not one that has previously had its registration
or listing cancelled;
32 At the end of subsection
28(5)
Add:
; and (c) in relation to each batch of the 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
(d) if requested to do so by an authorised person, make any such record
available to the authorised person for inspection:
(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 goods, with any reporting requirements that
are prescribed; and
(f) if a manufacturer who was not nominated as a manufacturer of the 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 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.
33 Subsection 29A(1)
After “registered”, insert “or listed”.
34 Paragraph 29A(2)(c)
After “registration”, insert “or
listing”.
35 At the end of subsection
29A(2)
Add:
; (d) information that indicates that the quality, safety or efficacy of
the goods is unacceptable.
36 Subsection 29B(1)
After “registration”, insert “or
listing”.
37 After paragraph 30(1)(d)
Insert:
(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
38 Paragraph 30(2)(c)
After “subject”, insert “(other than the condition under
paragraph 28(5)(d))”.
39 Subsections 30(6) and (7)
Repeal the subsections.
40 Sections 30A and 30B
Repeal the sections.
41 Saving provisions
(1) The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act
1989 does not affect the application, after the commencement of this item,
of paragraph 30(6)(b) and subsection 30(7) of that Act in relation to a
requirement imposed under paragraph 30(6)(a) of that Act before that
commencement.
(2) The repeal of section 30A of the Therapeutic Goods Act 1989
does not affect the application, after the commencement of this item, of
subsections 30A(3) and (4) of that Act in relation to a requirement imposed
under subsection 30A(2) of that Act before that commencement.
(3) The repeal of section 30B of the Therapeutic Goods Act 1989
does not affect the application, after the commencement of this item, of
subsections 30B(3), (4) and (5) of that Act in relation to a requirement imposed
under subsection 30B(2) of that Act before that commencement.
42 After Division 2 of
Part 3-2
Insert:
(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
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 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: but they do not conform with a standard applicable to the goods |
The person supplying the goods |
|
4. |
The goods are supplied while: but the manufacturing principles have not been observed in the manufacture
of the goods |
The person supplying the goods |
|
5. |
The goods are supplied in contravention of subsection 20(1) or
42E(1) |
The person supplying the goods |
|
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 |
|
7. |
The registration or listing of the goods has been cancelled under this
Part |
The person in relation to whom the goods were included in the
Register |
(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 recover 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;
(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.
(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.
(4) A requirement to recover therapeutic goods under this section does not
apply to therapeutic goods that cannot be recovered because they have been
administered to, or applied in the treatment of, a person.
The Secretary must cause to be published in the Gazette, as soon
as practicable after imposing a requirement under section 30EA, a notice
setting out particulars of the requirement.
A person is guilty of an offence if:
(a) the person does an act, or omits to do an act; and
(b) the act or omission constitutes a contravention of a requirement
imposed on the person under section 30EA.
Maximum penalty: 60 penalty units.
Imposition of a requirement under section 30EA does not affect the
Secretary’s power to cancel the registration or listing of therapeutic
goods under this Part.
43 Subsection 35(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
44 Subsection 35(2) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
45 Subsection 35(4) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
46 Paragraph 38(1)(d)
Omit “person”, substitute “applicant”.
47 Subsection 38(1)
Omit all the words after “Secretary must grant”,
substitute:
the applicant a licence to carry out those steps at those premises unless
the Secretary is satisfied that:
(e) the applicant will be unable to comply with the manufacturing
principles; or
(f) the premises are not satisfactory for the manufacture of the goods;
or
(g) the applicant is not a fit and proper person to hold a licence;
or
(h) a person who is participating in, or is likely to participate in,
managing the applicant’s affairs is not a fit and proper person to
participate in the management of the affairs of a holder of a licence;
or
(i) a person who has, or is likely to have, effective control over the
applicant is not a fit and proper person to have effective control over a holder
of a licence.
48 After subsection 38(1)
Insert:
(1A) Without limiting the matters to which the Secretary may have regard
in considering whether the applicant or person is not a fit and proper person
for the purposes of paragraph (1)(g), (h) or (i), the Secretary must have
regard to:
(a) any suspension or revocation of a manufacturing licence granted
to:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time of
the suspension or revocation; or
(b) any conviction, for an offence against a law of the Commonwealth or a
law of a State or Territory, against:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time the
offence was committed or the time of the conviction; or
(c) any failure to comply with a condition of a manufacturing licence
by:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time of
the failure.
(1B) In subsection (1A):
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.
49 Subsection 38(2)
Omit “paragraph (1)(f)”, substitute
“paragraphs (1)(g), (h) and (i)”.
50 Subsection 38(2)
Omit “a person”, substitute “an
applicant”.
51 Subsection 38(2)
Omit “that paragraph”, substitute “one or more of those
paragraphs”.
52 Subsection 38(3)
Omit “a person”, substitute “an
applicant”.
53 Paragraph 38(3)(a)
Omit “person”, substitute “applicant”.
54 Subsection 40(1)
Repeal the subsection, substitute:
(1) A licence may be granted subject to such conditions relating to the
manufacture of the goods as the Secretary thinks appropriate.
55 Saving provision
The repeal and substitution of subsection 40(1) of the Therapeutic Goods
Act 1989 does not affect the application, after the commencement of this
item, of any condition that:
(a) was imposed on a licence under that subsection; and
(b) was in force immediately before that commencement.
56 Paragraph 40(4)(a)
Repeal the paragraph, substitute:
(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;
and
57 After paragraph 40(4)(aa)
Insert:
(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
58 Subparagraph 40(4)(b)(ii)
Omit “, with the agreement of the holder,”.
59 At the end of
section 40
Add:
(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.
60 Application provision
Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by
this Act, and subsection 40(5) of that Act, apply to any licence in force after
the commencement of this item, whether or not the licence was granted after that
commencement.
61 Paragraphs 41(1)(aa) and
(ab)
Omit “a body corporate”, substitute “another
person”.
62 Paragraph 41(1)(ab)
Omit “the body” (wherever occurring), substitute “the
other person”.
63 Paragraph 41(1)(c)
Repeal the paragraph, substitute:
(c) the holder is controlled by another person (whether directly, or
indirectly through one or more interposed entities) and that other person has
breached a condition of a licence; or
(ca) the holder controls another person (whether directly, or indirectly
through one or more interposed entities) and that other person has, while
controlled by the holder, breached a condition of a licence; or
(cb) the holder is not a fit and proper person to hold a licence;
or
(cc) a person who is participating in managing the holder’s affairs
is not a fit and proper person to participate in the management of the affairs
of a holder of a licence; or
(cd) a person who has effective control over the holder is not a fit and
proper person to have effective control over a holder of a licence; or
64 After subsection 41(1)
Insert:
(1A) Without limiting the matters to which the Secretary may have regard
in considering whether the holder or another person is not a fit and proper
person for the purposes of paragraph (1)(cb), (cc) or (cd), the Secretary
must have regard to the matters set out in paragraphs 38(1A)(a), (b) and
(c).
65 At the end of
section 41EC
Add:
(3) In deciding whether to issue the certificate, the Secretary must also
consider:
(a) whether the applicant is a fit and proper person to hold a conformity
assessment certificate; and
(b) whether the persons who participate in, or who are likely to
participate in, managing the applicant’s affairs are fit and proper
persons to participate in managing the affairs of a manufacturer in respect of
whom a conformity assessment certificate is issued; and
(c) whether the persons who have, or are likely to have, effective control
over the applicant are fit and proper persons to have effective control over a
manufacturer in respect of whom a conformity assessment certificate is
issued.
(4) Without limiting the matters to which the Secretary may have regard in
considering whether the applicant or person is a fit and proper person for the
purposes of paragraph (3)(a), (b) or (c), the Secretary must have regard
to:
(a) any suspension or revocation of a conformity assessment certificate
issued to:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time of
the suspension or revocation; or
(b) any conviction, for an offence against a law of the Commonwealth or a
law of a State or Territory, against:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time the
offence was committed or the time of the conviction; or
(c) any failure to comply with a condition of a conformity assessment
certificate by:
(i) the applicant or person; or
(ii) another person who controls the applicant or person (whether
directly, or indirectly through one or more interposed entities); or
(iii) another person whom the applicant or person controlled (whether
directly, or indirectly through one or more interposed entities) at the time of
the failure.
66 At the end of subsection
41ET(1)
Add:
; or (e) the manufacturer is not a fit and proper person to be a
manufacturer in respect of whom a conformity assessment certificate is issued;
or
(f) a person who is participating in managing the manufacturer’s
affairs is not a fit and proper person to participate in managing the affairs of
a manufacturer in respect of whom a conformity assessment certificate is issued;
or
(g) a person who has effective control over the manufacturer is not a fit
and proper person to have effective control over a manufacturer in respect of
whom a conformity assessment certificate is issued.
67 After subsection 41ET(1)
Insert:
(1A) Without limiting the matters to which the Secretary may have regard
in considering whether the holder or another person is not a fit and proper
person for the purposes of paragraph (1)(e), (f) or (g), the Secretary must
have regard to the matters set out in paragraphs 41EC(4)(a), (b) and
(c).
68 Section 41FE (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
69 Subsection 41MA(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
70 Subsection 41MA(2) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
71 Subsection 41MA(3) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
72 Subsection 41ME(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
73 Subsection 41ME(2) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
74 Subsection 41MF(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
75 Subsection 41MF(2) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
76 Section 41MH (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
77 Subsection 41MI(1) (penalty)
Repeal the penalty, substitute:
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both.
78 Subsection 42E(4)
Omit “500 penalty units”, substitute “2,000 penalty
units”.
79 Subsection 54AA(1)
After “whichever of n or (3) applies”, insert “whichever
of subsection (2) or (3) applies”.
80 After section 54AA
Insert:
(1) A person is guilty of an offence if:
(a) the person damages, destroys, alters, conceals or falsifies a
document; and
(b) the document is created, retained or issued for the purposes of this
Act, or for purposes that include the purposes of this Act.
Maximum penalty: Imprisonment for 5 years or 2,000 penalty units, or
both.
(2) Strict liability applies to paragraph (1)(b).
Note: For strict liability, see section 6.1 of the
Criminal Code.
1 Clause 1 of Schedule 2 (definition of
medicine)
Repeal the definition.
2 Subclauses 6(2) to (8) of
Schedule 2
Repeal the subclauses, substitute:
(2) A broadcaster must not broadcast an advertisement relating to
therapeutic goods that is required to be approved under the Therapeutic Goods
Act 1989 unless the text of the advertisement has been so
approved.
3 Saving and transitional
provisions
(1) If, before the date of commencement of items 1 and 2 of this
Schedule:
(a) a person has applied, under clause 6 of Schedule 2 to the
Broadcasting Services Act 1992, to the Secretary (the Health
Secretary) of the Department whose Minister (the Health
Minister) is responsible for the administration of the Therapeutic
Goods Act 1989 for approval of an advertisement proposed for broadcasting;
and
(b) a decision has not been made by the Health Secretary before that
date;
that application is to be treated, on and after that date, for all purposes
as if it were an application for approval under the Therapeutic Goods
Regulations 1990.
(2) If, before the date of commencement of items 1 and 2 of this
Schedule:
(a) the Health Secretary has made a decision in relation to an
application, under clause 6 of Schedule 2 to the Broadcasting
Services Act 1992, for approval of an advertisement proposed for
broadcasting; and
(b) an appeal from that decision has not been made to the Minister
responsible for the administration of the Broadcasting Services Act
1992;
the person who sought that approval has the same right to appeal to the
Health Minister under the Therapeutic Goods Regulations 1990, on and
after that date, as if that decision had been made under those
regulations.
(3) If, before the date of commencement of items 1 and 2 of this
Schedule:
(a) the Health Secretary has made a decision in relation to an
application, under clause 6 of Schedule 2 to the Broadcasting
Services Act 1992, for approval of an advertisement proposed for
broadcasting; and
(b) an appeal from that decision has been made to the Minister responsible
for the administration of the Broadcasting Services Act 1992;
and
(c) the appeal has not been finally determined before that date;
that appeal is to continue to be dealt with under the Broadcasting
Services Act 1992, on and after that date, as if the amendments made by
items 1 and 2 had not been
made.
(143/02)