Commonwealth Numbered Acts Commonwealth Numbered Acts1 Subsection 3(1) (paragraph (1)(e) of the definition of therapeutic goods )
(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 ; 2 Subsection 3(1) (definition of Therapeutic Goods Advertising Code)
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) 4 Part 5-1 of Chapter 5 (heading)
(1) This Part does not
apply to advertisements directed exclusively to: 6 Section 42B
(a) the broadcasting of the advertisement in broadcast media; or
8 Section 42B
(a) an advertisement about the goods; or
10 Section 42B (definition of publisher)
(a) the publishing of the advertisement in specified media other than
broadcast media; or
12 Section 42B
13 Section 42B
14 Section 42B
(a) mainstream media; or
16 After section 42B Division 2—Therapeutic goods
advertisements for which an approval is required
(1) A person is guilty of an offence if: Penalty: 60
penalty units. (2) A person is guilty of an offence if: Penalty: 60
penalty units. (3) It is a defence to a prosecution under
subsection (2) if:
(4) A person is guilty of an offence if: Penalty: 30 penalty
units. (5) It is a defence to a prosecution under subsection (4)
if the person prosecuted:
(6) A person is guilty of an offence if: 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.
(8) An offence against this section is an offence of strict liability. Division 3—General
provisions about advertising 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.
Penalty: 60 penalty units. (2) For the purposes of an
offence against subsection (1), strict liability applies to the
following physical elements:
(1) A person is guilty of an offence if: Penalty: 60 penalty units. (2) An offence against
this section is an offence of strict liability. Penalty: 60
penalty units. (2) An offence against this section is an offence of
strict liability. ; or (l) under section 42DF, 42DH or
42DI. Part 3—Other amendments 21
Subsection 3(1)
22 Subsection 3(5) 23
Subsection 14(1) (penalty) Maximum penalty:
Imprisonment for 12 months or 1,000 penalty units, or both. 24 Subsection
14(3) (penalty) Maximum penalty:
Imprisonment for 12 months or 1,000 penalty units, or both. 25 Subsection
20(1AA) 26 After subsection 20(1A) (1B) A person is guilty of an
offence if: Maximum penalty:
Imprisonment for 12 months or 1,000 penalty units, or both. (1C) For
the purposes of paragraph (1B)(c): Maximum penalty:
Imprisonment for 12 months or 1,000 penalty units, or both. 28
Section 22A (penalty) Maximum
penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 29 After paragraph 25(1)(j) (ja) whether all of the
manufacturers of the goods are nominated as manufacturers of the goods
in the application; and ; or
(n) one or more of the manufacturers of the goods are not nominated as
manufacturers of the goods in the application. ; and (e) the medicine is not one that has
previously had its registration or listing cancelled; ; 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 34 Paragraph 29A(2)(c) 35 At the end of subsection 29A(2) ; (d)
information that indicates that the quality, safety or efficacy of the
goods is unacceptable. 37 After paragraph 30(1)(d) (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): 39 Subsections 30(6)
and (7) 40 Sections 30A and 30B 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. 42 After Division 2 of
Part 3-2 Division 2A—Public notification and
recovery of therapeutic goods (2) The requirements
may be one or more of the following: Maximum penalty: 60
penalty units. Maximum penalty: Imprisonment for 12 months or 1,000 penalty
units, or both. 44 Subsection 35(2) (penalty) Maximum penalty: Imprisonment for 12 months or 1,000 penalty
units, or both. 45 Subsection 35(4) (penalty) Maximum penalty: Imprisonment for 12 months or 1,000 penalty
units, or both. 46 Paragraph 38(1)(d) 47 Subsection 38(1)
(e) the applicant will be unable to comply with the manufacturing principles;
or (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) a licence granted under this Part; or 50 Subsection 38(2) 51 Subsection 38(2) 52
Subsection 38(3) 53
Paragraph 38(3)(a) 54
Subsection 40(1) (1) A licence
may be granted subject to such conditions relating to the manufacture
of the goods as the Secretary thinks appropriate. (a) was imposed on
a licence under that subsection; and (a) ensure that: (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 59 At the end of section 40 (5) The information with which paragraph (4)(ab) is concerned is
information of the following kinds: 61 Paragraphs 41(1)(aa) and (ab) 62 Paragraph 41(1)(ab)
63 Paragraph 41(1)(c) (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 (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). (3) In deciding
whether to issue the certificate, the Secretary must also consider: ;
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 (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).
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both. 69 Subsection 41MA(1) (penalty) Maximum penalty: Imprisonment for 12 months or 1,000
penalty units, or both. 70 Subsection 41MA(2) (penalty) Maximum penalty: Imprisonment for 12 months or
1,000 penalty units, or both. 71 Subsection 41MA(3) (penalty) Maximum penalty: Imprisonment for 12 months
or 1,000 penalty units, or both. 72 Subsection 41ME(1) (penalty) Maximum penalty: Imprisonment for 12
months or 1,000 penalty units, or both. 73 Subsection 41ME(2)
(penalty) Maximum penalty:
Imprisonment for 12 months or 1,000 penalty units, or both. 74
Subsection 41MF(1) (penalty) Maximum
penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 75 Subsection 41MF(2) (penalty)
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or
both. 76 Section 41MH (penalty) Maximum penalty: Imprisonment for 12 months or 1,000 penalty units,
or both. 77 Subsection 41MI(1) (penalty) Maximum penalty: Imprisonment for 12 months or 1,000
penalty units, or both. 78 Subsection 42E(4) 79 Subsection 54AA(1) 80 After section 54AA
(1) A person is guilty of an offence if: Maximum
penalty: Imprisonment for 5 years or 2,000 penalty units, or both. (2) Strict liability applies to paragraph (1)(b).
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.
(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.
42AB This
Part not to apply to advertisements for goods not for human use
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
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:
(b) the placement of the advertisement for such broadcasting.
7
Section 42B 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.
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:
(b) generic information included in an advertisement about the goods; or
(c) bona fide news.
9 Section 42B prohibited
representation means a representation referred to in subsection
42DJ(1).
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:
(b) the placement of the advertisement for such publication.
11
Section 42B publishing , in relation to an
advertisement, includes inserting material within the pages of an item
of mainstream media.
required representation means a representation
referred to in subsection 42DJ(2).
restricted representation means a
representation referred to in subsection 42DD(1).
specified media , in relation to an
advertisement or generic information, means:
(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 visual broadcast media
means broadcast media that is intended to be viewed by its audience.
This Division applies only to advertisements to which Part 2 of the
Therapeutic Goods Regulations applies.
17 Sections 42C and 42D
(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.
(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.
(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.
(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.
(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.
(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.
18 At
the end of Part 5-1 of Chapter 5
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:
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. applicant means an applicant for approval of the use of a
restricted representation in an advertisement about therapeutic 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.
(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).
(a) the person publishes or broadcasts an advertisement about therapeutic
goods; and
(b) the advertisement does not comply with the Therapeutic Goods
Advertising Code.
Division 4—Generic information about ingredients or
components of therapeutic goods
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.
19 Subsection 60(1) (at the end of the definition
of initial decision)
20 Subsection 3(1) (at the
end of paragraph (b) of the definition of authorised person) Customs officer means an officer of Customs
within the meaning of the Customs Act 1901 .
(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.
(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)
30 At the end of subsection 26(1)
31 After paragraph
26A(1)(d)
32 At the end
of subsection 28(5)
(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)
36 Subsection 29B(1)
(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)
(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.
(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: (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 they do not conform with a
standard applicable to the goods The person supplying the goods 4.
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 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
(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.
43 Subsection 35(1) (penalty) the applicant a licence to carry out those steps at those
premises unless the Secretary is satisfied that:
(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)
(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:
(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)
55 Saving provision
(b) was in force immediately before that commencement.
56 Paragraph
40(4)(a)
(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)
58 Subparagraph 40(4)(b)(ii)
(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
(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)
65 At the end of section 41EC
(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)
(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)
68 Section 41FE (penalty)
(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.
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