THERAPEUTIC GOODS ACT 1989
- Updated as at 14 January 1994 (HISTACT CHAP 1171 #DATE 14:01:1994)
*1* The Therapeutic Goods Act 1989 as shown in this reprint comprises Act No.
21, 1990 amended as indicated in the Tables below.
Table of Acts
Act Date of Date of Application,
Number Assent commencement saving or
and year transitional
provisions
Therapeutic Goods Act 1989
21, 1990 17 Jan 1990 15 Feb 1991
Community Services and Health Legislation Amendment Act (No. 2) 1990
141, 1990 28 Dec 1990 Part 8 (ss. 78-81): (a) -
Community Services and Health Legislation Amendment Act 1991
84, 1991 26 June 1991 S. 14: 1 Aug 1991 (see Ss. 33-36
s. 2 (2) and Gazette
1991, No. S207)
Remainder: Royal Assent
Therapeutic Goods Amendment Act 1991
204, 1991 24 Dec 1991 24 Dec 1991 Ss. 4 (2),
10 (2)
and 13 (2)
Health, Housing and Community Services Legislation Amendment Act 1992
88, 1992 30 June 1992 Ss. 82-88: Royal S. 83 (2)
Assent (b)
Health and Community Services Legislation Amendment Act (No. 2) 1993
76, 1993 25 Nov 1993 Ss. 28, 29 (a)-(g), Ss. 33 (2),
(j), 33-36, 37 (a), (c), 36 (2),
(d), 38 (a), (c), (d), 41 (2),
39-46, 48, 49, 50 (1) 49 (2),
(a)-(c), 50 (2), 51 and 52 50 (2)
: Royal Assent (see Note 2) and
Ss. 29 (h), (i), 30-32, 51 (2)
37 (b), 38 (b), 47 and 50
(1) (d): (see Note 2)
(a) The Therapeutic Goods Act 1989 was amended by Part 8 (sections 78-81)
only of the Community Services and Health Legislation Amendment Act (No. 2)
1990, subsection 2 (6) of which provides as follows:
"(6) Part 8 commences immediately after the commencement of the Therapeutic
Goods Act 1989."
The Therapeutic Goods Act 1989 came into operation on 15 February 1991.
(b) The Therapeutic Goods Act 1989 was amended by sections 82-88 only of the
Health, Housing and Community Services Legislation Amendment Act 1992,
subsection 2 (1) of which provides as follows:
"(1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent."
Table of Amendments
ad=added or inserted am=amended rep=repealed rs=repealed and substituted
Provision affected How affected
S. 3 am. No. 141, 1990; No. 84, 1991; No. 88, 1992; No.
76, 1993
S. 4 rs. No. 204, 1991
S. 7 am. No. 76, 1993
Ss. 7A, 7B ad. No. 76, 1993
S. 8 am. No. 84, 1991
S. 16 am. No. 141, 1990; No. 84, 1991; No. 76, 1993
S. 17 am. No. 84, 1991
S. 18 rs. No. 204, 1991
Ss. 19-22 am. No. 204, 1991
S. 22A ad. No. 204, 1991
S. 23 am. No. 84, 1991; No. 76, 1993
S. 24 am. Nos. 84 and 204, 1991
S. 24A ad. No. 84, 1991
am. No. 204, 1991
Ss. 24B, 24C ad. No. 84, 1991
S. 24D ad. No. 204, 1991
S. 24E ad. No. 88, 1992
S. 25 am. Nos. 84 and 204, 1991; No. 76, 1993
S. 26 am. No. 76, 1993
S. 27 rs. No. 84, 1991
S. 28 am. No. 84, 1991; No. 76, 1993
Ss. 29A, 29B ad. No. 88, 1992
S. 30 am. No. 88, 1992
S. 31 am. No. 84, 1991; No. 76, 1993
S. 32 am. Nos. 84 and 204, 1991; No. 76, 1993
Ss. 37, 38 am. No. 76, 1993
S. 40 am. No. 76, 1993
S. 42 am. No. 76, 1993
S. 44 am. No. 84, 1991
S. 47 am. No. 76, 1993
S. 54 am. No. 204, 1991; No. 76, 1993
S. 57 am. Nos. 84 and 204, 1991; No. 88, 1992
S. 58 am. No. 76, 1993
S. 61 am. No. 84, 1991; No. 88, 1992; No. 76, 1993
S. 63 am. No. 204, 1991; No. 76, 1993
S. 66 am. No. 76, 1993
Schedule am. No. 141, 1990
THERAPEUTIC GOODS ACT 1989 - TABLE OF PROVISIONS
TABLE
TABLE OF PROVISIONS
Section
PART 1 - PRELIMINARY
1. Short title
2. Commencement
3. Interpretation
4. Object of Act
5. Act to bind Crown
6. Operation of Act
6A-6C. (Not in operation - see Note 2)
7. Declaration that goods are/are not therapeutic goods
7A. Authorised persons
7B. Kits
8. Power to obtain information with respect to therapeutic goods
9. Arrangements with States etc.
PART 2 - STANDARDS
10. Determination of standards
11. Date of effect of standards
12. Standards to be disallowable
13. Special provisions relating to standards
14. Compliance with standards
15. Consent may be subject to conditions etc.
PART 3 - AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
Division 1 - Preliminary
16. Therapeutic goods and gazetted groups
17. Australian Register of Therapeutic Goods
18. Exempt goods
19. Exemptions for special and experimental uses
20. Offences by sponsors
21. Offence relating to wholesale supply
22. General offences relating to this Part
22A. False statements in applications for registration
Division 2 - Registration and Listing
23. Applications generally
24. Applications for registration
24A. When evaluation fee due for payment
24B. Payment of evaluation fee by instalments
24C. Recovery of evaluation fee
24D. Reduction of evaluation fee where evaluation not completed
within prescribed period
24E. Deemed refusal of application
25. Evaluation of therapeutic goods
26. Listing of therapeutic goods
27. Registration or listing number
28. Conditions of registration or listing
29. Duration of registration or listing
29A. Notification of adverse effects etc. of goods
29B. Notification of adverse effects etc. where application
withdrawn or lapses
30. Cancellation of registration or listing
Division 3 - General
31. Secretary may require information
32. Inspection and variation of entries in Register
33. Publication of list of goods on Register
PART 4 - MANUFACTURING OF THERAPEUTIC GOODS
34. Exempt goods and exempt persons
35. Offences relating to manufacturing and licences
36. Manufacturing principles
37. Application for licence
38. Grant of licence
39. Term of licence
40. Conditions of licences
41. Revocation and suspension of licences
42. Publication of list of manufacturers etc.
PART 5 - PAYMENT OF CHARGES
43. By whom charges payable
44. Time for payment of charges
45. Money to be paid into trust account
PART 6 - MISCELLANEOUS
46. Monitoring compliance with Act
47. Entry and search of premises - evidence of offences
48. General powers of authorised persons in relation to premises
49. Monitoring warrants
50. Offence related warrants
51. Offence related warrants by telephone
51A. (Not in operation - see Note 2)
52. Identity cards
53. Retention of material on withdrawal of applications
54. Offences
55. Conduct by directors, servants and agents
56. Judicial notice
57. Delegation
58. Export certifications
59. Fees
60. Review of decisions
61. Release of information
62. Consequential amendments
63. Regulations
PART 7 - REPEAL AND TRANSITIONAL PROVISIONS
64. Interpretation
65. Repeal
66. Transitional arrangements for goods required to be registered
or listed
67. Transitional provision for therapeutic goods for export only
68. Transitional arrangements for Part 4
69. Continuation of standards and requirements
SCHEDULE
CONSEQUENTIAL AMENDMENTS
THERAPEUTIC GOODS ACT 1989 - LONG TITLE
SECT
An Act relating to therapeutic goods
THERAPEUTIC GOODS ACT 1989 - PART 1
PART 1 - PRELIMINARY
THERAPEUTIC GOODS ACT 1989 - SECT 1
Short title
SECT
1. This Act may be cited as the Therapeutic Goods Act 1989.*1*
SEE NOTES TO FIRST ARTICLE OF THIS CHAPTER .
THERAPEUTIC GOODS ACT 1989 - SECT 2
Commencement
SECT
2.*1* This Act commences on the day after the day on which a House of the
Parliament approves regulations made under this Act in the same form as
approved by the other House, provided that:
(a) not more than 90 days have elapsed; and
(b) the places of Senators have not become vacant under section 13 of the
Constitution; and
(c) a dissolution or expiration of the House of Representatives has not
occurred;
between the approval of one House and the approval of the other House.
SEE NOTES TO FIRST ARTICLE OF THIS CHAPTER .
THERAPEUTIC GOODS ACT 1989 - SECT 3
Interpretation
SECT
3.*2* (1) In this Act, unless the contrary intention appears:
"advertisement", in relation to therapeutic goods, includes any statement,
pictorial representation or design, however made, that is intended, whether
directly or indirectly, to promote the use or supply of the goods;
"authorised person" means:
(a) in relation to any provision of this Act, a person authorised by the
Secretary to exercise powers under that provision; or
(b) in relation to a provision of Part 6, a member of the Australian Federal
Police;
"batch" means a quantity of a product that is:
(a) uniform in composition, method of manufacture and probability of
chemical or microbial contamination; and
(b) made in one cycle of manufacture and, in the case of a product that is
sterilised or freeze dried, sterilised or freeze dried in one cycle;
"bioburden", in relation to therapeutic goods, means the quantity and
characteristics of microorganisms present in the goods or to which the goods
may be exposed in a manufacturing environment;
"British Pharmacopoeia" means the edition of the book of that name,
including any additions or amendments, that was in effect for the purposes of
the Therapeutic Goods Act 1966 immediately before the commencement of this
section and, if additions or amendments of that book are made after that
commencement, or new editions of that book are published after that
commencement, includes those additions or amendments, or those new editions,
from a day specified by the Minister by order published in the Gazette;
"British Pharmacopoeia (Veterinary)" means the latest edition of the book of
that name, including any additions or amendments, published on the
recommendation of the Medicines Commission of the United Kingdom immediately
before the commencement of this section and, if additions or amendments of
that book are made after that commencement, or new editions of that book are
published after that commencement, includes those additions or amendments, or
those new editions, from a day specified by the Minister by order published in
the Gazette;
"container", in relation to therapeutic goods, means the vessel, bottle,
tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover
or other similar article that immediately covers the goods, but does not
include an article intended for ingestion;
"corporation" means a body corporate that is:
(a) a foreign corporation; or
(b) a trading corporation formed within the limits of the Commonwealth or a
financial corporation so formed;
"data processing device" means any article or material (for example, a disc)
from which information is capable of being reproduced with or without the aid
of any other article or device;
"directions for use", in relation to therapeutic goods, includes information
on:
(a) appropriate doses of the goods; and
(b) the method of administration or use of the goods; and
(c) the frequency and duration of treatment for each indication of the
goods; and
(d) the use of the goods by persons of particular ages or by persons having
particular medical conditions;
"exempt goods", in relation to a provision of Part 3 or 4, means therapeutic
goods that are exempted from the operation of that Part by the regulations;
"exempt person", in relation to therapeutic goods, means a person exempted
from the operation of Part 4 in relation to those goods by the regulations;
"financial corporation" means a financial corporation within the meaning of
paragraph 51 (xx) of the Constitution;
"foreign corporation" means a foreign corporation within the meaning of
paragraph 51 (xx) of the Constitution;
"gazetted kits group" means a group of kits identified in an order in force
under subsection 16 (3A);
"gazetted therapeutic devices group" has the meaning given by subsection 16
(3);
"gazetted therapeutic goods group" has the meaning given by subsection 16
(2);
"grouped therapeutic goods" means therapeutic goods included in:
(a) a gazetted therapeutic goods group; or
(b) a gazetted therapeutic devices group; or
(c) a gazetted kits group;
"indications", in relation to therapeutic goods, means the specific
therapeutic uses of the goods;
"label", in relation to therapeutic goods, means a display of printed
information:
(a) on or attached to the goods; or
(b) on or attached to a container or primary pack in which the goods are
supplied; or
(c) supplied with such a container or pack;
"licence" means a licence under Part 4;
"listable devices" means therapeutic devices that are required to be
included in the part of the Register for listed goods;
"listed goods" means therapeutic goods that are included in the Part of the
Register for goods known as listed goods;
"listing number", in relation to listed goods, means any combination of
numbers, symbols and letters assigned to the goods under section 27;
"manufacture", in relation to therapeutic goods, means:
(a) to produce the goods; or
(b) to engage in any part of the process of producing the goods or of
bringing the goods to their final state, including engaging in the processing,
assembling, packaging, labelling, storage, sterilising, testing or releasing
for supply of the goods or of any component or ingredient of the goods as part
of that process;
"manufacturing premises" means premises (including premises that comprise 2
or more sites):
(a) that are for use in the manufacture of a particular kind of therapeutic
goods; and
(b) at which the same persons have control of the management of the
production of the goods and the procedures for quality control;
"manufacturing principles" means the principles for the time being having
effect under section 36;
"premises" includes:
(a) a structure, building, aircraft, vehicle or vessel; and
(b) a place (whether enclosed or built upon or not); and
(c) a part of a thing referred to in paragraph (a) or (b);
"presentation", in relation to therapeutic goods, means the way in which the
goods are presented for supply, and includes matters relating to the name of
the goods, the labelling and packaging of the goods and any advertising or
other informational material associated with the goods;
"primary pack", in relation to therapeutic goods, means the complete pack in
which the goods, or the goods and their container, are to be supplied to
consumers;
"quality", in relation to therapeutic goods, includes the composition,
strength, potency, stability, sterility, purity, bioburden, design,
construction and performance characteristics of the goods;
"Register" means the Australian Register of Therapeutic Goods maintained
under section 17;
"registered goods" means therapeutic goods included in the part of the
Register for goods known as registered goods;
"registration number", in relation to registered goods, means any
combination of numbers, symbols and letters assigned to the goods under
section 27;
"Secretary" means the Secretary to the Department;
"sponsor", in relation to therapeutic goods, means:
(a) a person who exports, or arranges the exportation of, the goods from
Australia; or
(b) a person who imports, or arranges the importation of, the goods into
Australia; or
(c) a person who, in Australia, manufactures the goods, or arranges for
another person to manufacture the goods, for supply (whether in Australia or
elsewhere);
but does not include a person who:
(d) exports, imports or manufactures the goods; or
(e) arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation,
manufacture or arrangements, is a resident of, or is carrying on business in,
Australia;
"standard", in relation to therapeutic goods, means a standard that:
(a) is specified in an order under section 10 that is applicable to the
goods; or
(b) if no such order is applicable to the goods but the goods are the
subject of a monograph in:
(i) in the case of goods for use in humans - the British
Pharmacopoeia; or
(ii) in the case of goods for use in animals - the British
Pharmacopoeia (Veterinary);
is constituted by the statements in that monograph;
"supply" includes:
(a) supply by way of sale, exchange, gift, lease, loan, hire or
hire-purchase; and
(b) supply, whether free of charge or otherwise, by way of sample or
advertisement; and
(c) supply, whether free of charge or otherwise, in the course of testing
the safety or efficacy of therapeutic goods in persons or animals; and
(d) supply by way of administration to, or application in the treatment of,
a person or animal;
"therapeutic device" means therapeutic goods consisting of an instrument,
apparatus, appliance, material or other article (whether for use alone or in
combination), together with any accessories or software required for its
proper functioning, which does not achieve its principal intended action by
pharmacological, chemical, immunological or metabolic means though it may be
assisted in its function by such means, but the expression does not include
therapeutic goods declared by the Secretary, by order published in the
Gazette, not to be therapeutic devices;
"therapeutic goods" means goods:
(a) that are represented in any way to be, or that are, whether because of
the way in which the goods are presented or for any other reason, likely to be
taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of
therapeutic goods; or
(iii) for use as a container or part of a container for goods of the
kind referred to in subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use of which is, or
ordinarily is, a therapeutic use or a use of a kind referred to in
subparagraph (a) (ii) or (iii);
and includes goods declared to be therapeutic goods under an order in force
under section 7, but does not include:
(c) goods declared not to be therapeutic goods under an order in force under
section 7; or
(d) goods in respect of which such an order is in force, being an order that
declares the goods not to be therapeutic goods when used, advertised, or
presented for supply in the way specified in the order where the goods are
used, advertised, or presented for supply in that way; or
(e) foods;
"therapeutic use" means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect
or injury in persons or animals; or
(b) influencing, inhibiting or modifying a physiological process in persons
or animals; or
(c) testing the susceptibility of persons or animals to a disease or
ailment; or
(d) influencing, controlling or preventing conception in persons; or
(e) testing for pregnancy in persons; or
(f) the replacement or modification of parts of the anatomy in persons or
animals;
"trading corporation" means a trading corporation within the meaning of
paragraph 51 (xx) of the Constitution.
(2) For the purposes of this Act:
(a) therapeutic goods are to be taken to be for use in animals if:
(i) the goods bear a name or description that indicates, or is
likely to give the impression, that the goods are intended for use in animals
and are not intended for use in humans; or
(ii) the goods are otherwise represented, or otherwise purport, to
be intended for use in animals and not intended for use in humans; and
(b) therapeutic goods are to be taken to be for use in humans if they are
not solely for use in animals.
(3) The Secretary must, at least once in each year, cause to be published in
the Gazette a list of the names of all persons, other than members of the
Australian Federal Police, who are, at the time of publication, authorised
persons.
(4) The provisions of this Act are in addition to, and not in substitution
for, the provisions of any other Act that relate to therapeutic goods.
(5) For the purposes of this Act, the presentation of therapeutic goods is
unacceptable if it is capable of being misleading or confusing as to the
content or proper use of the goods and, without limiting the previous words in
this subsection, the presentation of therapeutic goods is unacceptable:
(a) if it states or suggests that the goods have ingredients, components or
characteristics that they do not have; or
(b) if a name applied to the goods is the same as the name applied to other
therapeutic goods that are supplied in Australia where those other goods
contain additional or different therapeutically active ingredients; or
(c) if the label of the goods does not declare the presence of a
therapeutically active ingredient; or
(d) if a form of presentation of the goods may lead to unsafe use of the
goods or suggests a purpose that is not in accordance with conditions
applicable to the supply of the goods in Australia; or
(e) in prescribed cases.
(6) A reference in this Act to an annual registration charge, an annual
listing charge or an annual licensing charge is a reference to such a charge
imposed under the Therapeutic Goods (Charges) Act 1989.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 4
Object of Act
SECT
4.*2* The object of this Act is to provide, so far as the Constitution
permits, for the establishment and maintenance of a national system of
controls relating to the quality, safety, efficacy and timely availability of
therapeutic goods that are:
(a) used in Australia, whether those goods are produced in Australia or
elsewhere; or
(b) exported from Australia.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 5
Act to bind Crown
SECT
5. This Act binds the Crown in right of the Commonwealth, of each of the
States, of the Australian Capital Territory and of the Northern Territory, but
nothing in this Act renders the Crown liable to be prosecuted for an offence.
THERAPEUTIC GOODS ACT 1989 - SECT 6
Operation of Act
SECT
6.*2* (1) This Act applies to:
(a) things done by corporations; and
(b) things done by natural persons or corporations in so far as those things
are done:
(i) in the course of, or in preparation for, trade or commerce
between Australia and a place outside Australia, among the States, between a
State and a Territory or between 2 Territories; or
(ii) under a law of the Commonwealth relating to the provision of
pharmaceutical or repatriation benefits; or
(iii) in relation to the Commonwealth or in relation to an authority
of the Commonwealth.
(2) Without limiting the effect of this Act apart from this subsection, this
Act also has the effect it would have if the reference in paragraph (1) (a) to
things done by corporations were confined to things done by trading
corporations for the purposes of their trading activities.
(3) The provisions of this Act are intended to apply to the exclusion of any
law of a State or Territory, other than laws identified in the regulations for
the purposes of this subsection.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 6A-6C
SECT
6A-6C.*2* * * * * * *
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 7
Declaration that goods are/are not therapeutic goods
SECT
7. (1) Where the Secretary is satisfied that particular goods or classes of
goods:
(a) are or are not therapeutic goods; or
(b) when used, advertised, or presented for supply in a particular way, are
or are not therapeutic goods;
the Secretary may, by order published in the Gazette, declare that the goods,
or the goods when used, advertised, or presented for supply in that way, are
or are not, for the purposes of this Act, therapeutic goods.
(2) The Secretary may exercise his or her powers under this section of his
or her own motion or following an application made in writing to the
Secretary.
(3) A declaration under this section takes effect on the day on which the
declaration is published in the Gazette or on such later day as is specified
in the order.
THERAPEUTIC GOODS ACT 1989 - SECT 7A
Authorised persons
SECT
7A. The Secretary may, in writing, authorise any of the following persons to
exercise powers under a specified provision of this Act:
(a) an officer of the Department, of another Department or of an authority
of the Commonwealth;
(b) an officer of:
(i) a Department of State of a State; or
(ii) a Department or administrative unit of the Public Service of a
Territory; or
(iii) an authority of a State or of a Territory;
being a Department, unit or authority that has functions relating to health
matters or law enforcement matters.
THERAPEUTIC GOODS ACT 1989 - SECT 7B
Kits
SECT
7B. (1) A package and therapeutic goods in the package together constitute a
kit for the purposes of this Act if:
(a) the package and the therapeutic goods are for use as a unit; and
(b) each item of the therapeutic goods consists of goods that are registered
or listed or are exempt goods in relation to Part 3; and
(c) the package and therapeutic goods do not constitute a composite pack.
(2) A package and therapeutic goods in the package together constitute a
composite pack if:
(a) the therapeutic goods are of 2 or more kinds; and
(b) the package does not contain any therapeutic devices; and
(c) the therapeutic goods are for administration as a single treatment or as
a single course of treatment; and
(d) it is necessary that the therapeutic goods be combined before
administration or that they be administered in a particular sequence.
(3) To avoid doubt, it is declared that a kit constitutes therapeutic goods.
THERAPEUTIC GOODS ACT 1989 - SECT 8
Power to obtain information with respect to therapeutic goods
SECT
8. (1) The Secretary may, by notice in writing given to a person who has
imported into Australia or has supplied in Australia:
(a) therapeutic goods; or
(b) goods in relation to which the Secretary is considering making a
declaration under section 7;
request the person to give to an officer of the Department identified in the
notice, within such reasonable period as is specified in the notice,
information required by the notice concerning the composition, indications,
directions for use or labelling of the goods or concerning advertising
material relating to the goods.
(1A) A notice under subsection (1) may require the information to be given:
(a) in writing; or
(b) in accordance with specified software requirements:
(i) on a specified kind of data processing device; or
(ii) by way of a specified kind of electronic transmission.
(2) A person must not, without reasonable excuse, fail to comply with a
notice given to the person under this section.
(3) A person must not, in purported compliance with a notice under this
section, knowingly or recklessly provide information that is false or
misleading in a material particular.
Penalty: $6,000.
THERAPEUTIC GOODS ACT 1989 - SECT 9
Arrangements with States etc.
SECT
9. (1) The Minister may make arrangements with the appropriate Minister of a
State, of the Australian Capital Territory or of the Northern Territory for
the carrying out by that State or Territory, on behalf of the Commonwealth,
of:
(a) the evaluation of therapeutic goods for registration; or
(b) the inspection of manufacturers of therapeutic goods; or
(c) other functions under this Act or the regulations.
(2) An arrangement under this section may provide for the payment to a State
or Territory of amounts in respect of the performance of functions under the
arrangement.
THERAPEUTIC GOODS ACT 1989 - PART 2
PART 2 - STANDARDS
THERAPEUTIC GOODS ACT 1989 - SECT 10
Determination of standards
SECT
10. (1) The Minister may, by order published in the Gazette, determine that
matters specified in the order constitute a standard for therapeutic goods or
a class of therapeutic goods identified in the order (whether or not those
goods are the subject of a monograph in the British Pharmacopoeia or the
British Pharmacopoeia (Veterinary)).
(2) Without limiting the generality of subsection (1), an order establishing
a standard for therapeutic goods may:
(a) be specified by reference to:
(i) the quality of the goods; or
(ii) the quantity of the goods when contained in specified
containers; or
(iii) procedures to be carried out in the manufacture of the goods;
or
(iv) a monograph in the British Pharmacopoeia or the British
Pharmacopoeia (Veterinary); or
(v) a monograph in another publication approved by the Minister for
the purposes of this subsection; or
(vi) such a monograph as modified in a manner specified in the order
establishing the standard; or
(vii) a standard published by the Standards Association of
Australia; or
(viii) such other matters as the Minister thinks fit; or
(b) require that a matter relating to the standard be determined in
accordance with a particular test; or
(c) require that therapeutic goods or a class of therapeutic goods
identified in the order be labelled or packaged in a manner, or kept in
containers that comply with requirements, specified in the order.
(3) Without limiting the generality of paragraph (2) (c), the Minister may,
in an order establishing a standard, direct that there be set out, in a manner
specified in the order, on:
(a) therapeutic goods or a class of therapeutic goods identified in the
order; or
(b) a container or package containing therapeutic goods or a class of
therapeutic goods identified in the order; or
(c) a label of therapeutic goods or a class of therapeutic goods identified
in the order;
such particulars as are required by the order.
(4) The Minister must not determine a standard or amend or revoke a standard
unless the Minister has consulted with respect to the proposed action with a
committee established by the regulations to advise the Minister on standards.
THERAPEUTIC GOODS ACT 1989 - SECT 11
Date of effect of standards
SECT
11. A standard under section 10 takes effect on the day on which the order
establishing the standard is published in the Gazette or on such later day as
is specified in the order.
THERAPEUTIC GOODS ACT 1989 - SECT 12
Standards to be disallowable
SECT
12. Standards under section 10 and orders revoking, varying or modifying
standards of that kind are disallowable instruments for the purposes of
section 46A of the Acts Interpretation Act 1901.
THERAPEUTIC GOODS ACT 1989 - SECT 13
Special provisions relating to standards
SECT
13. (1) Unless the contrary intention appears in a standard, the standard
applies to therapeutic goods for use in humans and therapeutic goods for use
in animals.
(2) For the purposes of this Part, where a statement in a monograph in the
British Pharmacopoeia or the British Pharmacopoeia (Veterinary) refers to a
statement in a monograph in another publication, the first-mentioned statement
is to be taken to include the other statement.
(3) Subject to subsection (4), where:
(a) a standard applicable to therapeutic goods is constituted by statements
in a monograph in the British Pharmacopoeia or the British Pharmacopoeia
(Veterinary); and
(b) requirements applicable to the labelling or packaging of the goods are
specified in the British Pharmacopoeia or the British Pharmacopoeia
(Veterinary); and
(c) the goods are not labelled or packaged in accordance with those
requirements;
the goods are to be taken not to comply with that standard.
(4) Where:
(a) a standard under section 10 applies to therapeutic goods; and
(b) requirements applicable to the goods are specified in the British
Pharmacopoeia or the British Pharmacopoeia (Veterinary); and
(c) those requirements are inconsistent with the requirements specified in
the standard;
the requirements referred to in paragraph (b) are, so far as they are
inconsistent, to be disregarded for the purposes of this Act.
(5) Where:
(a) a standard applies to a class of therapeutic goods; and
(b) another standard applies to some only of the therapeutic goods within
that class; and
(c) those standards are inconsistent;
the standard referred to in paragraph (a) is, to the extent of the
inconsistency, of no effect in relation to the goods referred to in paragraph
(b).
(6) Where:
(a) therapeutic goods consist, or are represented to consist, of a mixture
of ingredients or of a combination of component parts; and
(b) a standard is applicable to the mixture or the combination;
that standard takes precedence over any standard that is applicable to the
ingredients or the component parts.
(7) Where:
(a) therapeutic goods consist, or are represented to consist, of a mixture
of ingredients or of a combination of component parts; and
(b) there is no standard applicable to the goods but a standard is
applicable to at least one of the ingredients or component parts; and
(c) the Minister has, by order published in the Gazette, determined that the
standard does not apply to the goods;
the standard is to be disregarded in so far as it would otherwise apply to the
goods.
THERAPEUTIC GOODS ACT 1989 - SECT 14
Compliance with standards
SECT
14. (1) Except with the consent in writing of the Secretary, a person must
not:
(a) import therapeutic goods into Australia; or
(b) supply therapeutic goods for use in Australia;
if the goods do not conform with a standard applicable to the goods.
Penalty: $24,000.
(2) Paragraph (1) (a) does not apply to goods that do not conform with a
standard applicable to the goods by reason only of matters relating to
labelling or packaging.
(3) Except in exceptional circumstances and with the consent in writing of
the Secretary, a person must not export therapeutic goods from Australia if
the goods do not conform with a standard applicable to the goods (other than a
standard relating to the labelling of the goods for supply in Australia).
Penalty: $24,000.
(4) Where:
(a) the importation or exportation of goods is prohibited under subsection
(1) or (3); and
(b) the Secretary notifies the Comptroller-General in writing that the
Secretary wishes the Customs Act 1901 to apply to that importation or
exportation;
the goods are, for the purposes of that Act, to be taken to be prohibited
imports or prohibited exports, as the case may be.
(5) The Secretary must, as soon as practicable after making a decision to
give a consent under this section, cause particulars of the decision to be
published in the Gazette.
(6) The Secretary must, within 28 days after making a decision to refuse to
give a consent under this section, notify the applicant in writing of the
decision and of the reasons for the decision.
THERAPEUTIC GOODS ACT 1989 - SECT 15
Consent may be subject to conditions etc.
SECT
15. (1) The consent of the Secretary under section 14 may be given:
(a) unconditionally or subject to conditions; or
(b) in respect of particular goods or classes of goods.
(2) Where a person breaches a condition of such a consent, the person is
guilty of an offence.
Penalty: $12,000.
THERAPEUTIC GOODS ACT 1989 - PART 3
PART 3 - AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
THERAPEUTIC GOODS ACT 1989 - DIVISION 1
Division 1 - Preliminary
THERAPEUTIC GOODS ACT 1989 - SECT 16
Therapeutic goods and gazetted groups
SECT
16. (1) For the purposes of this Part, therapeutic goods are to be taken to
be separate and distinct from other therapeutic goods if they have:
(a) a different formulation, composition or design specification; or
(b) a different strength or size (disregarding pack size); or
(c) a different dosage form or model; or
(d) a different name; or
(e) different indications; or
(f) different directions for use; or
(g) a different type of container (disregarding container size).
(2) The Secretary may, by order published in the Gazette, determine that a
group of therapeutic goods (not being therapeutic devices) identified in the
order is a gazetted therapeutic goods group because the goods within the group
have common characteristics.
(3) The Secretary may, by order published in the Gazette, determine that a
group of therapeutic goods (being therapeutic devices) identified in the order
is a gazetted therapeutic devices group because the goods within the group:
(a) have common characteristics; and
(b) have been produced by the same manufacturer.
(3A) The Secretary may, by order published in the Gazette, determine that a
group of kits identified in the order is a gazetted kits group.
(4) An order under subsection (2), (3) or (3A) may make provision for or in
relation to a matter by applying, adopting or incorporating, with or without
modification, a document as in force from time to time, if the document is:
(a) published by the Department (whether in electronic form or otherwise);
and
(b) available for sale to the public; and
(c) available for inspection (whether by using a visual display unit or
otherwise) by the public at offices of the Department specified by the
Secretary.
THERAPEUTIC GOODS ACT 1989 - SECT 17
Australian Register of Therapeutic Goods
SECT
17. (1) The Secretary is to cause to be maintained a register, to be known
as the Australian Register of Therapeutic Goods, for the purpose of compiling
information in relation to, and providing for evaluation of, therapeutic goods
for use in humans.
(2) Subject to subsection (3), the Register is to be kept in such form as
the Secretary determines.
(3) The Register is to contain 2 parts, one relating to goods to be known as
registered goods and the other relating to goods to be known as listed goods.
(4) The regulations may:
(a) prescribe the therapeutic goods, or the classes of therapeutic goods,
that are required to be included in each part of the Register; and
(b) prescribe the ways in which goods that are included in one part of the
Register may be transferred, or may be required to be transferred, to the
other part of the Register; and
(c) prescribe the ways in which goods that have been assigned a registration
or listing number may be assigned a different registration or listing number.
THERAPEUTIC GOODS ACT 1989 - SECT 18
Exempt goods
SECT
18. (1) The regulations may, subject to such conditions (if any) as are
specified in the regulations, exempt:
(a) all therapeutic goods, except those included in a class of goods
prescribed for the purposes of this paragraph; or
(b) specified therapeutic goods; or
(c) a specified class of therapeutic goods;
from the operation of this Part.
(2) An exemption in terms of paragraph (1) (a) has effect only in relation
to such classes of persons as are prescribed for the purposes of this
subsection.
(3) Where the regulations revoke an exemption, the revocation takes effect
on the day, not being earlier than 28 days after the day on which the
regulations are made, specified in the regulations.
THERAPEUTIC GOODS ACT 1989 - SECT 19
Exemptions for special and experimental uses
SECT
19. (1) The Secretary may, by notice in writing, grant an approval to a
person for the importation into, or the exportation from, Australia or the
supply in Australia of specified therapeutic goods that are not either exempt
goods or goods included in the Register:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
and such an approval may be given subject to such conditions as are specified
in the notice of approval.
(2) An application for an approval must be made to the Secretary and must:
(a) in the case of an application for use of the kind referred to in
paragraph (1) (a) - be accompanied by such information relating to the goods
the subject of the application as is required by the Secretary; and
(b) in the case of an application for use of the kind referred to in
paragraph (1) (b):
(i) be made in writing; and
(ii) be accompanied by such information relating to the goods the
subject of the application as is required by the Secretary; and
(iii) be accompanied by the prescribed evaluation fee.
(3) Without limiting the conditions to which an approval under subsection
(1) may be made subject, those conditions may include a condition relating to
the charges that may be made for the therapeutic goods to which the approval
relates.
(4) Where an application for an approval is made, the Secretary must, after
having considered the application and, in the case of an application for the
use of therapeutic goods for experimental purposes in humans, after having
evaluated the information submitted with the application, notify the applicant
of the decision on the application within 28 days of making the decision and,
in the case of a decision not to grant the approval, of the reasons for the
decision.
(5) The Secretary may, in writing, authorise a specified medical
practitioner to supply:
(a) specified therapeutic goods for use in the treatment of humans; or
(b) a specified class of such goods;
to the class or classes of recipients specified in the authority.
(6) An authority under subsection (5) may only be given:
(a) to a medical practitioner included in a class of medical practitioners
prescribed by the regulations for the purposes of this paragraph; and
(b) in relation to a class or classes of recipients prescribed by the
regulations for the purposes of this paragraph.
(7) The regulations may prescribe the circumstances in which therapeutic
goods may be supplied under an authority under subsection (5).
(8) The giving of an authority under subsection (5) does not render the
Commonwealth, the Secretary or a delegate of the Secretary liable to a person
in respect of loss, damage or injury of any kind suffered by the person as a
result of, or arising out of, the use of therapeutic goods by that person or
another person.
(9) In this section, "medical practitioner" means a person who is
registered, in a State or internal Territory, as a medical practitioner.
THERAPEUTIC GOODS ACT 1989 - SECT 20
Offences by sponsors
SECT
20. (1) A person who is the sponsor of therapeutic goods must not knowingly
or recklessly:
(a) import the goods into Australia for use in humans; or
(b) export the goods from Australia for use in humans; or
(c) manufacture the goods for supply in Australia for use in humans; or
(d) supply the goods in Australia for use in humans;
unless:
(e) the goods are registered goods or listed goods in relation to the
person; or
(f) the goods are exempt goods or are the subject of an approval or
authority under section 19.
Penalty: $24,000.
(2) A person in relation to whom therapeutic goods are registered or listed
must not knowingly or recklessly:
(a) import those goods into Australia; or
(c) supply those goods in Australia;
unless:
(d) the registration number or listing number of the goods is set out on the
label of the goods in the prescribed manner or, in the case of an importation,
that number is so set out, or is to be so set out before the goods are
supplied in Australia; or
(e) the goods are devices that are listed goods or are listed goods that
have been manufactured in Australia for export only.
Penalty: $6,000.
(3) Where:
(a) the importation or exportation of goods is prohibited under subsection
(1); and
(b) the Secretary notifies the Comptroller-General in writing that the
Secretary wishes the Customs Act 1901 to apply to that importation or
exportation;
the goods are, for the purposes of that Act, to be taken to be prohibited
imports or prohibited exports, as the case may be.
THERAPEUTIC GOODS ACT 1989 - SECT 21
Offence relating to wholesale supply
SECT
21. A person must not knowingly or recklessly supply in Australia
therapeutic goods for use in humans (other than listable devices), being goods
of which the person is not a sponsor, to another person who is not the
ultimate consumer of the goods unless:
(a) the goods are registered goods or listed goods; or
(b) the goods are exempt goods or are the subject of an approval or
authority under section 19.
Penalty: $12,000.
THERAPEUTIC GOODS ACT 1989 - SECT 22
General offences relating to this Part
SECT
22. (1) A person must not knowingly or recklessly set out or cause to be set
out, on a container or package that contains therapeutic goods or on a label
of goods of that kind, a number that purports to be the registration number or
listing number of the goods in relation to a particular person if the number
is not that number.
(2) A person must not, in or in connection with an application for listing
of therapeutic goods, knowingly or recklessly make a statement that is false
or misleading in a material particular.
(3) A person in relation to whom therapeutic goods are registered or listed
must not knowingly or recklessly breach a condition of the registration or
listing of the goods.
(4) A person must not knowingly or recklessly:
(a) represent therapeutic goods that are not included in the Register as
being so included; or
(b) represent therapeutic goods that are not exempt goods as being exempt
goods; or
(c) represent therapeutic goods that are included in one part of the
Register as being included in the other part of the Register.
(5) A person, being the sponsor of therapeutic goods that are included in
the Register, must not, by any means, knowingly or recklessly advertise the
goods for an indication other than those accepted in relation to the inclusion
of the goods in the Register.
(6) A person must not knowingly or recklessly make a claim, by any means,
that the person or another person can arrange the supply of therapeutic goods
(not being exempt goods) that are not registered goods or listed goods.
(7) A person must not knowingly or recklessly breach a condition of:
(a) an exemption applicable under regulations made for the purposes of
subsection 18 (1); or
(b) an approval under section 19.
(7A) A person to whom an authority under subsection 19 (5) has been granted
must not supply the therapeutic goods to which the authority relates except in
accordance with:
(a) the authority; and
(b) any regulations made for the purpose of subsection 19 (7).
(8) A person must not knowingly or recklessly use therapeutic goods that are
not either exempt goods or goods included in the Register:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
except in accordance with an approval or authority under section 19.
Penalty: $6,000.
THERAPEUTIC GOODS ACT 1989 - SECT 22A
False statements in applications for registration
SECT
22A. A person must not, in or in connection with an application for
registration of therapeutic goods, knowingly or recklessly make a statement
that is false or misleading in a material particular.
Penalty: $40,000.
THERAPEUTIC GOODS ACT 1989 - DIVISION 2
Division 2 - Registration and Listing
THERAPEUTIC GOODS ACT 1989 - SECT 23
Applications generally
SECT
23. (1) An application for registration or listing of therapeutic goods
must:
(a) be made in accordance with a form approved, in writing, by the Secretary
or in such other manner as is approved, in writing, by the Secretary; and
(b) be delivered to an office of the Department specified by the Secretary.
(2) An application is not effective unless:
(a) the prescribed application fee has been paid; and
(b) the applicant has delivered to the office to which the application was
made such information, in a form approved, in writing, by the Secretary, as
will allow the determination of the application; and
(c) if the Secretary so requires - the applicant has delivered to the office
to which the application was made a reasonable number of samples of the goods.
(3) An approval of a form may require or permit an application or
information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
THERAPEUTIC GOODS ACT 1989 - SECT 24
Applications for registration
SECT
24. (1) Where an application is made for the registration of therapeutic
goods in accordance with section 23 and the goods are goods that are required
to be registered, a fee specified in or determined in accordance with the
regulations is payable by the applicant in respect of the evaluation of the
goods for registration, and the Secretary must notify each such applicant of
the amount of the evaluation fee.
(2) Subject to section 24D, an application for registration of therapeutic
goods lapses if:
(a) any part of the evaluation fee payable in respect of those goods remains
unpaid at the end of the period of 2 months after the day on which the amount
became due and payable; or
(b) the application contains information that is inaccurate or misleading in
a material particular; or
(c) information given to the Secretary by, or on behalf of, the applicant in
connection with the application, including information given for the purpose
of a requirement under section 31, is inaccurate or misleading in a material
particular; or
(d) the applicant fails to comply with a requirement under section 31 to
give information consisting of individual patient data in relation to the
goods.
(3) In this section, "individual patient data", in relation to therapeutic
goods, means information, derived from clinical trials, relating to
individuals before, during and after the administration of the goods to those
individuals, including, but not limited to, demographic, biochemical and
haematological information.
THERAPEUTIC GOODS ACT 1989 - SECT 24A
When evaluation fee due for payment
SECT
24A. Subject to sections 24B and 24D, an evaluation fee under section 24
payable by an applicant is due and payable on the day on which the applicant
is notified of the amount of the evaluation fee.
THERAPEUTIC GOODS ACT 1989 - SECT 24B
Payment of evaluation fee by instalments
SECT
24B. (1) The regulations may provide for the payment of an evaluation fee
under section 24 to be made by such instalments and at such times as are
ascertained in accordance with the regulations, and the evaluation fee is due
and payable accordingly.
(2) Regulations made for the purposes of subsection (1) may provide that a
person is not allowed to pay an evaluation fee under section 24 by instalments
if any part of an instalment of that or any other evaluation fee payable by
the person was unpaid immediately after the time when it became due for
payment.
(3) Subsection (2) does not limit the generality of subsection (1).
THERAPEUTIC GOODS ACT 1989 - SECT 24C
Recovery of evaluation fee
SECT
24C. An evaluation fee under section 24 may be recovered by the Commonwealth
as a debt due to the Commonwealth.
THERAPEUTIC GOODS ACT 1989 - SECT 24D
Reduction of evaluation fee where evaluation not completed within
prescribed period
SECT
24D. (1) This section applies to an application under section 23 in relation
to therapeutic goods for the evaluation of which a period is prescribed under
paragraph 63 (2) (da).
(2) Nothing in section 24, 24A or 24B requires the applicant to pay more
than three-quarters of the evaluation fee before the completion of the
evaluation of the goods.
(3) If the evaluation is not completed within the period referred to in
subsection (1), this Act has effect as if the evaluation fee were reduced to
three-quarters of the fee that, under the regulations, would have been the
evaluation fee.
(4) If:
(a) the evaluation is completed within the period referred to in subsection
(1); and
(b) part of the evaluation fee under section 24 is unpaid when the
evaluation is completed;
that part becomes due and payable on the completion of the evaluation.
(5) For the purposes of subsections (2), (3) and (4), the evaluation is to
be taken to be completed when the applicant is notified according to
subsection 25 (3) of the Secretary's decision on the application.
THERAPEUTIC GOODS ACT 1989 - SECT 24E
Deemed refusal of application
SECT
24E. (1) This section applies in the case of an application under section 23
in relation to therapeutic goods for the evaluation of which a period is
prescribed under paragraph 63 (2) (da).
(2) If, at the end of the period referred to in subsection (1), the
evaluation has not been completed, the applicant may give the Secretary
written notice that the applicant wishes to treat the application as having
been refused.
(3) A notice under subsection (2) may be given at any time before the
evaluation is completed.
(4) Where a notice has been given, this Act (except for subsection 60 (5))
has effect as if:
(a) the Secretary had decided not to register the goods the subject of the
application; and
(b) the Minister had made a decision under subsection 60 (3) confirming the
decision of the Secretary; and
(c) the Minister's decision had been made on the day on which notice was
given to the Secretary under subsection (2).
THERAPEUTIC GOODS ACT 1989 - SECT 25
Evaluation of therapeutic goods
SECT
25.*2* (1) Where:
(a) an application is made for the registration of therapeutic goods in
relation to a person in accordance with section 23; and
(b) there is no part of an evaluation fee under section 24 in respect of
those goods that:
(i) is due and payable by the person; and
(ii) remains unpaid; and
(c) the person has complied with any requirements made by the Secretary
under section 31 in relation to the goods;
the goods are to be evaluated for registration having regard to:
(d) whether the quality, safety and efficacy of the goods for the purposes
for which they are to be used have been satisfactorily established; and
(e) whether the presentation of the goods is acceptable; and
(f) whether the goods conform to any standard applicable to the goods, or
any requirements relating to advertising applicable under the regulations;
and
(g) if a step in the manufacture of the goods has been carried out outside
Australia - whether the manufacturing and quality control procedures used in
the manufacture of the goods are acceptable; and
(h) if the goods have been manufactured in Australia - whether the goods
have been manufactured in accordance with Part 4; and
(j) whether the goods contain substances that are prohibited imports for the
purposes of the Customs Act 1901; and
(k) such other matters (if any) as the Secretary considers relevant.
(2) In making a decision for the purposes of paragraph (1) (g), the matters
that may be taken into account include:
(a) whether the applicant has provided an acceptable form of evidence from a
relevant overseas authority to establish that the manufacture of the goods is
of an acceptable standard; and
(b) whether the applicant has agreed to provide, where the Secretary
considers inspection of the manufacturing procedures used in the manufacture
of the goods to be necessary:
(i) funds for the carrying out of that inspection by the Department;
and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) An evaluation under this section of goods in relation to which a period
has been prescribed under paragraph 63 (2) (da) must be completed within that
period.
(2B) If therapeutic goods are exempt from the operation of Part 4 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to the goods,
as if paragraph (h) were omitted.
(2C) If a person is exempt from the operation of Part 4 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has effect, in
relation to the goods, as if the reference in paragraph (h) to Part 4 were a
reference to that Part to the extent that it applies to that person in
relation to the manufacture of the goods.
(2D) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been exempt from
the operation of Part 4;
subsection (1) has effect, in relation to the goods, as if paragraph (g) were
omitted.
(3) After therapeutic goods have been evaluated for registration, the
Secretary must:
(a) notify the applicant in writing of his or her decision on the evaluation
within 28 days of the making of the decision and, in the case of a decision
not to register the goods, of the reasons for the decision; and
(b) if the decision is to register the goods - include the goods in the
Register and give the applicant a certificate of registration.
(5) The registration of therapeutic goods commences on the day specified for
the purpose in the certificate of registration.
(6) The failure to complete an evaluation within the period mentioned in
subsection (2A) does not render the Commonwealth, the Secretary or a delegate
of the Secretary liable to a person in respect of loss, damage or injury of
any kind caused by, or arising out of, the failure.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 26
Listing of therapeutic goods
SECT
26.*2* (1) Where:
(a) an application is made for the listing of therapeutic goods in relation
to a person in accordance with section 23; and
(b) the person has complied with any requirements made by the Secretary
under section 31 in relation to the goods;
the Secretary is not to refuse to list the goods in relation to the person
except where the Secretary is satisfied that:
(c) the goods are not eligible for listing; or
(d) the goods are not safe for the purposes for which they are to be used;
or
(e) the presentation of the goods is unacceptable; or
(f) the goods do not conform to a standard applicable to the goods or to a
requirement relating to advertising applicable under the regulations; or
(g) if a step in the manufacture of the goods (not being therapeutic devices
other than devices prescribed for the purposes of this paragraph) has been
carried out outside Australia - the manufacturing and quality control
procedures used in the manufacture of the goods are not acceptable; or
(h) if the goods have been manufactured in Australia - the goods have been
manufactured contrary to Part 4; or
(j) if the goods have been manufactured in Australia solely for export and:
(i) the goods have been refused registration or listing for supply
in Australia; or
(ii) the Secretary requires such a confirmation for other reasons;
a relevant authority of the country to which the goods are to be exported has
not confirmed its willingness to accept the goods; or
(k) the goods do not comply with prescribed quality or safety criteria; or
(m) the goods contain substances that are prohibited imports for the
purposes of the Customs Act 1901.
(2) In making a decision for the purposes of paragraph (1) (g), the matters
that may be taken into account include:
(a) whether the applicant has provided an acceptable form of evidence from a
relevant overseas authority to establish that the manufacture of the goods is
of an acceptable standard; and
(b) whether the applicant has agreed to provide, where the Secretary
considers inspection of the manufacturing procedures used in the manufacture
of the goods to be necessary:
(i) funds for the carrying out of that inspection by the Department;
and
(ii) evidence that the manufacturer has agreed to such an
inspection.
(2A) If therapeutic goods are exempt from the operation of Part 4 or a
person is exempt from the operation of that Part in relation to the
manufacture of the goods, subsection (1) has effect, in relation to the goods,
as if paragraph (h) were omitted.
(2B) If a person is exempt from the operation of Part 4 in relation to a
step in the manufacture of therapeutic goods, subsection (1) has effect, in
relation to the goods, as if the reference in paragraph (h) to Part 4 were a
reference to that Part to the extent that it applies to that person in
relation to the manufacture of the goods.
(2C) If:
(a) therapeutic goods were made outside Australia; and
(b) had the goods been made in Australia, they would have been exempt from
the operation of Part 4;
subsection (1) has effect, in relation to the goods, as if paragraph (g) were
omitted.
(3) Where an application is made, the Secretary must notify the applicant in
writing of his or her decision on the application within 28 days of the making
of the decision and, in the case of a decision not to list the goods, of the
reasons for the decision.
(4) As soon as practicable after an applicant has been informed that
therapeutic goods in respect of which an application was made are acceptable
for listing, the Secretary must give to the applicant a certificate of listing
of the goods, and the listing of the goods commences on the day specified for
the purpose in the certificate.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 27
Registration or listing number
SECT
27. (1) Where the Secretary includes therapeutic goods (other than grouped
therapeutic goods) in the Register, the Secretary is to assign a unique
registration or listing number to the goods.
(2) Where the Secretary includes grouped therapeutic goods in the Register,
the Secretary is to assign a single, unique registration or listing number to
the grouped therapeutic goods.
THERAPEUTIC GOODS ACT 1989 - SECT 28
Conditions of registration or listing
SECT
28. (1) Where the Secretary includes therapeutic goods in the Register in
relation to a person the Secretary may, in writing, impose conditions on the
registration or listing of those goods.
(2) Conditions referred to in subsection (1) may relate to:
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the goods; or
(c) the keeping of records relating to the goods; or
(d) matters dealt with in, or matters additional to matters dealt with in,
standards applicable to the goods; or
(e) such other matters relating to the goods as the Secretary thinks
appropriate.
(3) The Secretary may, by notice in writing given to the person in relation
to whom therapeutic goods are registered or listed, impose new conditions on
the registration or listing or vary or remove existing conditions.
(3A) The Secretary's power under subsection (3) may be exercised at the
request of the person concerned or of the Secretary's own motion.
(4) The imposition or variation of a condition under subsection (3) takes
effect:
(a) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury - on the day on which the
notice is given to the person; or
(b) in any other case - on the day specified for the purpose in the notice,
being a day not earlier than 28 days after the notice is given to the person.
(5) In addition to any conditions imposed under subsection (1) or (3), the
registration or listing of therapeutic goods is subject to the conditions that
the person in relation to whom the goods are registered or listed will:
(a) allowed an authorised person:
(i) to enter, at any reasonable time, premises at which the person
deals with the goods; and
(ii) while on those premises, to inspect those premises and
therapeutic goods at those premises and to take samples of goods of that kind;
and
(b) if requested to do so by an authorised person, produce to the person
such documents relating to the goods as the person requires and allow the
person to copy the documents.
THERAPEUTIC GOODS ACT 1989 - SECT 29
Duration of registration or listing
SECT
29. Where goods are included in the Register in relation to a person, the
goods remain so included until their registration or listing is cancelled
under this Part.
THERAPEUTIC GOODS ACT 1989 - SECT 29A
Notification of adverse effects etc. of goods
SECT
29A. (1) As soon as a person in relation to whom therapeutic goods are
registered becomes aware of information of a kind mentioned in subsection (2)
relating to the goods, the person must give the information to the Secretary
in writing.
Penalty: $40,000.
(2) The information with which subsection (1) is concerned is information of
the following kinds:
(a) information that contradicts information already furnished by the person
under this Act;
(b) information that indicates that the use of the goods in accordance with
the recommendations for their use may have an unintended harmful effect;
(c) information that indicates that the goods, when used in accordance with
the recommendations for their use, may not be as effective as the application
for registration of the goods or information already furnished by the person
under this Act suggests.
THERAPEUTIC GOODS ACT 1989 - SECT 29B
Notification of adverse effects etc. where application withdrawn or
lapses
SECT
29B. (1) If an application for registration of goods is withdrawn or lapses,
the Secretary may give the applicant written notice requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is aware of any
information of a kind mentioned in subsection 29A (2) relating to the goods;
and
(b) if the applicant is aware of such information, to give the information
to the Secretary in writing.
(2) Notice under subsection (1) may be given within 14 days after an
application is withdrawn or lapses.
(3) A person must comply with the requirements of a notice under subsection
(1) within 30 days after the notice is given to the person.
Penalty: $40,000.
(4) A person must not, in purported compliance with a notice under
subsection (1), knowingly or recklessly give information that is false or
misleading in a material particular.
Penalty: $40,000.
THERAPEUTIC GOODS ACT 1989 - SECT 30
Cancellation of registration or listing
SECT
30. (1) The Secretary may, by notice in writing given to a person in
relation to whom therapeutic goods are included in the Register, cancel the
registration or listing of the goods if:
(a) it appears to the Secretary that failure to cancel the registration or
listing would create an imminent risk of death, serious illness or serious
injury; or
(b) the goods become exempt goods; or
(c) the person requests in writing the cancellation of the registration or
listing; or
(d) the goods contain substances that are prohibited imports for the
purposes of the Customs Act 1901.
(2) Subject to subsection (3), the Secretary may, by notice in writing given
to a person in relation to whom therapeutic goods are included in the
Register, cancel the registration or listing of the goods if:
(a) it appears to the Secretary that the quality, safety or efficacy of the
goods is unacceptable; or
(b) the goods have changed so that they have become separate and distinct
from the goods as so included; or
(c) the sponsor has refused or failed to comply with a condition to which
the inclusion of the goods is subject; or
(ca) the person has contravened subsection 29A (1) in relation to the goods;
or
(d) the goods become required to be included in the other part of the
Register; or
(e) the goods do not conform to a standard applicable to the goods or to a
requirement relating to advertising applicable to the goods under the
regulations; or
(f) the annual registration or listing charge is not paid within 28 days
after it becomes payable.
(3) Where the Secretary proposes to cancel the registration or listing of
goods in relation to a person under subsection (2) otherwise than as a result
of a failure to pay the annual registration or listing charge, the Secretary
must:
(a) inform the person in writing that the Secretary proposes to cancel that
registration or listing and set out the reasons for that proposed action; and
(b) give the person a reasonable opportunity to make submissions to the
Secretary in relation to the proposed action.
(4) Where a person makes submissions in accordance with paragraph (3) (b),
the Secretary is not to make a decision relating to the cancellation until the
Secretary has taken the submissions into account.
(5) Where the Secretary cancels the registration or listing of goods in
relation to a person, the goods cease to be registered or listed:
(a) if the cancellation is effected under subsection (1) - on the day on
which the notice of cancellation is given to the person; or
(b) in any other case - on such later day as is specified in the notice.
(6) Where the Secretary cancels the registration or listing of goods in
relation to a person, the Secretary:
(a) may, in writing, require the person:
(i) to inform the public, or a specified class of persons, in the
specified manner and within such reasonable period as is specified, of the
cancellation; or
(ii) to take steps to recover any of the goods that have been
distributed; and
(b) must cause to be published in the Gazette, as soon as practicable after
the cancellation, a notice setting out particulars of the cancellation.
(7) A person who knowingly or recklessly refuses or fails to comply with a
requirement under paragraph (6) (a) is guilty of an offence.
Penalty for a contravention of this subsection: $6,000.
THERAPEUTIC GOODS ACT 1989 - DIVISION 3
Division 3 - General
THERAPEUTIC GOODS ACT 1989 - SECT 31
Secretary may require information
SECT
31. (1) The Secretary may, by notice in writing given to a person who is an
applicant for the registration of therapeutic goods or in relation to whom
therapeutic goods are registered, require the person to give to the Secretary,
within such reasonable time as is specified in the notice and in such form as
is specified in the notice, information or documents relating to one or more
of the following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the quality of the goods;
(e) the method and place of manufacture or preparation of the goods and the
procedures employed to ensure that proper standards are maintained in the
manufacture and handling of the goods;
(f) the presentation of the goods;
(g) the safety and efficacy of the goods for the purposes for which they are
to be used;
(h) the conformity of the goods to a requirement relating to advertising
applicable under the regulations;
(j) the regulatory history of the goods in another country;
(k) any other matter prescribed by the regulations for the purposes of this
paragraph in relation to goods of that kind.
(2) The Secretary may, by notice in writing given to a person who is an
applicant for the listing of therapeutic goods or in relation to whom
therapeutic goods are listed, require the person to give to the Secretary,
within such reasonable time as is specified in the notice, information or
documents relating to one or more of the following:
(a) the formulation of the goods;
(b) the composition of the goods;
(c) the design specifications of the goods;
(d) the manufacturer of the goods;
(e) the presentation of the goods;
(f) the safety of the goods for the purposes for which they are to be used;
(g) the conformity of the goods to a standard applicable to the goods, or to
a requirement relating to advertising applicable to the goods under the
regulations;
(h) any other matter prescribed by the regulations for the purposes of this
paragraph in relation to goods of that kind.
(3) An approval of a form may require or permit information to be given in
accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.
(4) A person in relation to whom therapeutic goods are registered or listed
must not, without reasonable excuse, fail to comply with a notice given to the
person under this section.
Penalty: 60 penalty units.
(5) A person in relation to whom therapeutic goods are registered or listed
must not, in purported compliance with a notice under this section, knowingly
or recklessly provide information that is false or misleading in a material
particular.
Penalty: 60 penalty units.
THERAPEUTIC GOODS ACT 1989 - SECT 32
Inspection and variation of entries in Register
SECT
32. (1) The Register is not open for public inspection, but a person in
relation to whom therapeutic goods are registered or listed may make a written
request to the Secretary for a copy of the entry in the Register in relation
to the goods and, where such a request is made, the Secretary must send a copy
of that entry to the person (other than any part of that entry that was
supplied in confidence by another person).
(2A) If a person makes such a request, then, instead of providing a copy of
an entry to the person, the Secretary may, if the request is for the provision
of the copy in an electronic form, provide the information contained in the
entry:
(a) on a data processing device; or
(b) by way of electronic transmission.
(3) The Secretary may, following a request by a person in relation to whom
therapeutic goods are registered or listed or of his or her own motion, vary
the entry in the Register in relation to the goods if the entry contains
information that is incomplete or incorrect.
(4) Where:
(a) the person in relation to whom therapeutic goods are registered or
listed has asked the Secretary to vary product information included in the
entry in the Register that relates to the goods; and
(b) the only effect of the variation would be to reduce the class of persons
for whom the goods are suitable or to add a warning or precaution, being a
warning or precaution that does not include any comparison of the goods with
any other therapeutic goods by reference to quality, safety or efficacy;
the Secretary must vary the entry in accordance with the request.
(5) Where:
(a) the person in relation to whom therapeutic goods are registered or
listed has asked the Secretary to vary information included in the entry in
the Register that relates to the goods; and
(b) subsection (4) does not apply to the request; and
(c) the Secretary is satisfied that the variation requested does not
indicate any reduction in the quality, safety or efficacy of the goods for the
purposes for which they are to be used;
the Secretary may vary the entry in accordance with the request.
(6) In this section, "product information", in relation to therapeutic
goods, means information relating to the safe and effective use of the goods,
including information regarding the usefulness and limitations of the goods.
THERAPEUTIC GOODS ACT 1989 - SECT 33
Publication of list of goods on Register
SECT
33. The Secretary must publish a list of the therapeutic goods included in
the Register not less than once every twelve months.
THERAPEUTIC GOODS ACT 1989 - PART 4
PART 4 - MANUFACTURING OF THERAPEUTIC GOODS
THERAPEUTIC GOODS ACT 1989 - SECT 34
Exempt goods and exempt persons
SECT
34. (1) The regulations may exempt therapeutic goods or a class of
therapeutic goods identified in the regulations from the operation of this
Part.
(2) The regulations may exempt a person identified in the regulations from
the operation of this Part in relation to the manufacture or a step in the
manufacture of therapeutic goods or a class of therapeutic goods identified in
the regulations.
(3) Where the regulations revoke an exemption, the revocation takes effect
on the day, not being earlier than 28 days after the day on which the
regulations are made, as is specified in the regulations.
THERAPEUTIC GOODS ACT 1989 - SECT 35
Offences relating to manufacturing and licences
SECT
35. (1) A person must not, at premises in Australia, knowingly or recklessly
carry out a step in the manufacture of therapeutic goods for supply for use in
humans unless:
(a) the goods are exempt goods or the person is an exempt person in relation
to the manufacture of the goods; or
(b) the person is the holder of a licence that is in force that authorises
the carrying out of that step in relation to the goods at those premises.
Penalty: $24,000.
(2) A person who is the holder of a licence must not knowingly or recklessly
breach a condition of the licence.
Penalty: $12,000.
(3) A person must not, in or in connection with an application for a licence
to manufacture therapeutic goods for use in humans, make a statement that is,
to the person's knowledge, false or misleading in a material particular.
Penalty for a contravention of this subsection: $6,000.
THERAPEUTIC GOODS ACT 1989 - SECT 36
Manufacturing principles
SECT
36. (1) The Minister may, from time to time, determine written principles to
be observed in the manufacture of therapeutic goods or use in humans.
(2) The manufacturing principles may relate to:
(a) the standards to be maintained, and the equipment to be used, at
premises used for the manufacturing of therapeutic goods for use in humans;
or
(b) procedures for quality assurance and quality control to be employed in
the manufacturing of therapeutic goods for use in humans; or
(c) the qualifications and experience required of persons employed in the
manufacture of therapeutic goods for use in humans; or
(d) the manufacturing practices to be employed in the manufacturing of
therapeutic goods for use in humans; or
(e) other matters relevant to the quality, safety and efficacy of
therapeutic goods for use in humans that are manufactured in Australia;
and may include codes of good manufacturing practice.
(3) The Minister may, before taking action under subsection (1) in relation
to the manufacturing principles, obtain advice from a committee established by
the regulations on the action that should be taken under that subsection as to
the principles to be observed in the manufacture of therapeutic goods for use
in humans.
(4) Manufacturing principles are disallowable instruments for the purposes
of section 46A of the Acts Interpretation Act 1901.
THERAPEUTIC GOODS ACT 1989 - SECT 37
Application for licence
SECT
37. (1) An application for a licence must:
(a) be made in writing in accordance with a form approved by the Secretary;
and
(b) identify the therapeutic goods or classes of therapeutic goods that the
applicant proposes to manufacture; and
(c) identify the manufacturing premises that will be used in the manufacture
of those goods; and
(d) identify the steps in the manufacture of those goods that the applicant
proposes to carry out under the licence; and
(e) state the names, qualifications and experience of the persons who are to
have control of the production of the goods and of the quality control
measures that are to be employed; and
(f) be delivered to an office of the Department specified in the form; and
(g) be accompanied by the prescribed application fee.
(2) The Secretary may, by notice in writing given to an applicant for a
licence, require the applicant:
(a) to give to the Secretary, within such reasonable time as is specified in
the notice, such further information concerning the application as is
specified in the notice; or
(b) to allow an authorised person, at any reasonable time specified in the
notice, to inspect the premises, equipment, processes and facilities that will
be used in the manufacture of the goods, or other goods on those premises.
THERAPEUTIC GOODS ACT 1989 - SECT 38
Grant of licence
SECT
38. (1) Where:
(a) a person has made an application to carry out steps in the manufacture
of therapeutic goods at particular manufacturing premises; and
(b) the prescribed application fee has been paid; and
(c) any applicable prescribed inspection fees have been paid; and
(d) the person has complied with any requirements made by the Secretary
under subsection 37 (2) in relation to the application;
the Secretary must grant the person a licence to carry out those steps at
those premises unless:
(e) the Secretary is satisfied that:
(i) the person will be unable to comply with the manufacturing
principles; or
(ii) the premises are not satisfactory for the manufacture of the
goods; or
(f) the person:
(i) has had a licence granted to the person revoked; or
(ii) has been convicted of an offence against this Act or a law of a
State or Territory relating to therapeutic goods; or
(iii) has failed on more than one occasion to observe the
manufacturing principles in connection with the manufacture of therapeutic
goods.
(2) Notwithstanding paragraph (1) (f), the Secretary may grant a licence to
a person who, apart from this subsection, could not be granted a licence
because of that paragraph if, in the opinion of the Secretary, special
circumstances make it appropriate to do so.
(3) Where the Secretary grants or refuses to grant a licence to a person,
the Secretary must:
(a) give the person written notice of the decision; and
(b) in the case of a refusal - include in the notice the reasons for the
refusal.
(4) Where the Secretary grants a licence, the Secretary must cause
particulars of the decision to be published in the Gazette as soon as is
practicable after the decision is made.
THERAPEUTIC GOODS ACT 1989 - SECT 39
Term of licence
SECT
39. A licence commences on the day specified in the licence and remains in
force until it is revoked or suspended.
THERAPEUTIC GOODS ACT 1989 - SECT 40
Conditions of licences
SECT
40. (1) A licence may be granted subject to:
(a) conditions designed to ensure that the holder of the licence
manufactures the goods in accordance with the manufacturing principles and any
standards applicable to the goods; and
(b) such other conditions relating to the manufacture of the goods as the
Secretary thinks appropriate.
(2) The Secretary may, by notice in writing given to the holder of a
licence, impose new conditions on the licence or vary or remove existing
conditions.
(3) The imposition or variation of a condition under subsection (2) takes
effect:
(a) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury - on the day on which the
notice is given to the person; or
(b) in any other case - on the day specified for the purpose in the notice,
being a day not earlier than 28 days after the notice is given to the person.
(4) In addition to any conditions imposed under subsection (1) or (2), each
licence is, except as otherwise specified in the licence, subject to the
conditions that the holder of the licence will:
(a) ensure that the goods conform to any standard applicable to the goods;
and
(b) allow an authorised person:
(i) to enter, at any reasonable time, the manufacturing premises to
which the licence relates; and
(ii) while on those premises, to inspect those premises, any
therapeutic goods manufactured at those premises and processes relating to
that manufacture, and to take samples of goods of that kind and, with the
agreement of the holder, to take photographs of those premises, goods or
processes; and
(c) where an authorised person enters premises as mentioned in subparagraph
(b) (i), require the holder or his or her employees at those premises to
answer questions relating to procedures carried out at the premises; and
(d) if requested to do so by an authorised person:
(i) produce to the person such documents relating to the manufacture
of therapeutic goods manufactured at those premises as the person requires and
allow the person to copy the documents; or
(ii) produce to the person for examination any batch samples kept by
the holder; and
(e) comply with such other conditions (if any) as are specified in the
regulations for the purposes of this section.
THERAPEUTIC GOODS ACT 1989 - SECT 41
Revocation and suspension of licences
SECT
41. (1) Subject to subsection (2), the Secretary may, by notice in writing
given to the holder of a licence, revoke the licence, or suspend the licence
for a period specified in the notice, if:
(a) the holder has been convicted of an offence against this Act; or
(b) the holder has breached a condition of the licence; or
(c) the holder has failed to observe the manufacturing principles; or
(d) the holder requests in writing that the licence be revoked or suspended,
as the case may be; or
(e) the holder ceases to carry on the business of manufacturing the goods to
which the licence relates; or
(f) the annual licensing charge, or any applicable prescribed inspection
fees, have not been paid within 28 days after they become payable.
(2) Where the Secretary proposes to revoke a licence or suspend a licence
otherwise than at the request of the holder of the licence, the Secretary
must, unless the Secretary considers that failure to revoke or suspend the
licence immediately would create an imminent risk of death, serious illness or
serious injury:
(a) by notice in writing given to the holder, inform the holder of the
action that the Secretary proposes to take and of the reasons for that
proposed action; and
(b) except where the proposed action is to be taken as a result of a failure
to pay the annual licensing charge or an applicable prescribed inspection fee
- give the holder an opportunity to make, within such reasonable time as is
specified in the notice, submissions to the Secretary in relation to the
proposed action.
(3) Where the holder makes submissions in accordance with paragraph (2) (b),
the Secretary is not to make a decision relating to the revocation or
suspension of the licence before taking into account the submissions.
(4) A licence may be revoked notwithstanding that the licence is suspended.
(5) Where a licence is suspended, the Secretary may, by notice in writing
given to the holder of the licence, revoke the suspension.
(6) Where the Secretary revokes or suspends a licence, the Secretary must
cause particulars of the decision to be published in the Gazette as soon as is
practicable after the decision is made.
THERAPEUTIC GOODS ACT 1989 - SECT 42
Publication of list of manufacturers etc.
SECT
42. The Secretary may, from time to time and in such manner as the Secretary
determines, publish a list of the persons who are licensed under this Part,
the classes of goods to which the licences relate, the steps of manufacture
that the licences authorise and the addresses of the manufacturing premises to
which the licences relate.
THERAPEUTIC GOODS ACT 1989 - PART 5
PART 5 - PAYMENT OF CHARGES
THERAPEUTIC GOODS ACT 1989 - SECT 43
By whom charges payable
SECT
43. (1) An annual registration charge or annual listing charge is payable by
the person in relation to whom the therapeutic goods concerned are registered
or listed.
(2) An annual licensing charge is payable by the holder of the licence to
which the charge relates.
THERAPEUTIC GOODS ACT 1989 - SECT 44
Time for payment of charges
SECT
44. (1) An annual registration charge or annual listing charge for a
financial year that relates to therapeutic goods other than grouped
therapeutic goods becomes payable:
(a) if the charge is imposed in respect of therapeutic goods the
registration or listing of which commenced before 1 July 1990:
(i) in the case of charge for the financial year commencing on 1
July 1990 - on that day; or
(ii) in the case of a later financial year - on 1 July in that
financial year or, if the Secretary has, by notice in writing given before 1
July 1991 to the person in relation to whom the therapeutic goods concerned
are registered or listed, specified another day as being the day on which the
charge becomes payable, on the specified day or on an anniversary of that day,
as the case requires; or
(b) in any other case:
(i) if the year is the financial year (in this paragraph called the
"first year") during which the registration or listing of the therapeutic
goods concerned commenced - on that commencement; or
(ii) if the year is a later financial year - on the anniversary of
that commencement or, if the Secretary has, by notice in writing given before
the end of the first year to the person in relation to whom the therapeutic
goods concerned are registered or listed, specified another day as being the
day on which charge becomes payable, on the specified day or on an anniversary
of that day, as the case requires.
(1A) An annual registration charge or annual listing charge for a financial
year that relates to grouped therapeutic goods becomes payable by a person on
the day specified in relation to those grouped therapeutic goods in a written
notice given by the Secretary to the person.
(2) An annual licensing charge for a financial year becomes payable:
(a) if the licence commenced before 1 July 1990 - on 1 July 1990 and on each
anniversary of that day; or
(b) in any other case - on the day on which the licence commenced and on
each anniversary of that day.
(3) The Secretary may, by agreement with the person by whom an annual
registration charge, an annual listing charge or an annual licensing charge is
payable, vary the day on which the charge becomes payable in a financial year.
THERAPEUTIC GOODS ACT 1989 - SECT 45
Money to be paid into trust account
SECT
45. (1) Amounts equal to amounts received by the Commonwealth by way of
annual registration charge, annual listing charge and annual licensing charge
are to be paid into the trust account established under the Audit Act 1901 and
known as the Therapeutic Goods Administration Trust Account.
(2) Payments under subsection (1) are to be made out of the Consolidated
Revenue Fund, which is appropriated accordingly.
THERAPEUTIC GOODS ACT 1989 - PART 6
PART 6 - MISCELLANEOUS
THERAPEUTIC GOODS ACT 1989 - SECT 46
Monitoring compliance with Act
SECT
46. (1) Subject to subsection (2), an authorised person may, for the purpose
of finding out whether the requirements of this Act are being complied with:
(a) enter premises; and
(b) exercise the powers set out in subsection 48 (1) in relation to the
premises.
(2) An authorised person must not enter premises, or exercise a power under
subsection (1) in relation to the premises, unless:
(a) the occupier of the premises consents to the entry or the exercise of
the power; or
(b) a warrant under section 49 authorises the entry or the exercise of the
power.
THERAPEUTIC GOODS ACT 1989 - SECT 47
Entry and search of premises - evidence of offences
SECT
47. (1) Subject to subsection (3), an authorised person who has reasonable
grounds for suspecting that there is in or on premises a particular thing (in
this section called the "evidence") that may afford evidence of the commission
of an offence against this Act, the authorised person may:
(a) enter the premises; and
(b) exercise the powers set out in subsection 48 (1) in relation to the
premises.
(2) If the authorised person enters the premises and finds the evidence, the
following provisions have effect:
(a) the authorised person may seize the evidence;
(b) the authorised person may keep the evidence for 60 days or, if a
prosecution for an offence against this Act in the commission of which the
evidence may have been used or otherwise involved is instituted within that
period, until the completion of the proceedings for the offence and of any
appeal from the decision in relation to the proceedings;
(c) if the evidence is a book, record or document - while the authorised
person has possession of the book, record or document, the authorised person
must allow the book, record or document to be inspected at any reasonable time
by a person who would be entitled to inspect it if it were not in the
authorised person's possession.
(3) The authorised person must not enter the premises, or exercise a power
in relation to the premises under subsection (1), unless:
(a) the occupier of the premises consents to the entry or the exercise of
the power; or
(b) a warrant under section 50 issued in relation to the evidence authorises
the entry or the exercise of the power.
(4) If, in the course of searching the premises under subsection (1)
pursuant to a warrant under section 50, the authorised person:
(a) finds a thing that the authorised person believes, on reasonable
grounds, to be a thing (other than the evidence) that will afford evidence of
the commission of the offence mentioned in subsection (1) or of another
offence against this Act; and
(b) the authorised person believes, on reasonable grounds, that it is
necessary to seize the thing to prevent:
(i) its concealment, loss or destruction; or
(ii) its use in committing, continuing or repeating the offence
mentioned in subsection (1) or the other offence;
subsection (2) applies to the thing as if it were the evidence.
(5) An authorised person may, before the end of the period mentioned in
paragraph (2) (b), apply to a magistrate for an extension of that period.
(6) A person who would be entitled to possession of the evidence if it had
not been seized is entitled to make representations to the magistrate about
the application.
(7) The magistrate may extend the period if satisfied that it is necessary
to do so in order that an authorised person may have a reasonable opportunity
of completing the investigation of an offence against this Act.
(8) The period may not be extended:
(a) after it has ended; or
(b) so that it exceeds 2 years.
(9) Where the period referred to in paragraph (2) (b) has been extended, a
reference in subsection (5), (7) or (8) to that period is a reference to that
period as extended.
THERAPEUTIC GOODS ACT 1989 - SECT 48
General powers of authorised persons in relation to premises
SECT
48. (1) The powers an authorised person may exercise under paragraph 46 (1)
(b) or 47 (1) (b) in relation to premises are as follows:
(a) to search any part of the premises;
(b) to inspect, examine, take measurements of, or conduct tests (including
by the taking of samples) concerning, any thing in or on the premises that
relates to therapeutic goods;
(c) to take extracts from, and make copies of, any documents relating to
therapeutic goods in or on the premises;
(d) if the authorised person was only authorised to enter the premises
because the occupier of the premises consented to the entry - to require the
occupier to:
(i) answer any questions put by the authorised person; and
(ii) produce any books, records or documents requested by the
authorised person; and
(e) if the authorised person was authorised to enter the premises by a
warrant under section 49 or 50 - to require any person in or on the premises
to:
(i) answer any questions put by the authorised person; and
(ii) produce any books, records or documents requested by the
authorised person;
(f) to take into or onto the premises such equipment and materials as the
authorised person requires for the purposes of exercising powers in relation
to the premises.
(2) Subsection (1) has effect subject to subsections 46 (2) and 47 (3).
(3) A person must not, without reasonable excuse, refuse or fail to comply
with a requirement under paragraph (1) (e).
Penalty: $3,000.
(4) It is a reasonable excuse for a person to refuse or fail to answer a
question or produce a document if answering the question, or producing the
document, would tend to incriminate the person.
THERAPEUTIC GOODS ACT 1989 - SECT 49
Monitoring warrants
SECT
49. (1) An authorised person may apply to a magistrate for a warrant under
this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if the
magistrate is satisfied, by information on oath, that it is reasonably
necessary that the authorised person should have access to the premises for
the purpose of finding out whether the requirements of this Act are being
complied with.
(3) The magistrate must not issue the warrant unless the authorised person
or some other person has given to the magistrate, either orally or by
affidavit, such further information (if any) as the magistrate requires
concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) authorise an authorised person (whether or not named in the warrant),
with such assistance and by such force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsection 48 (1) in relation
to the premises; and
(b) state whether the entry is authorised to be made at any time of the day
or night or during specified hours of the day or night; and
(c) specify the day (not more than 6 months after the issue of the warrant)
on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
THERAPEUTIC GOODS ACT 1989 - SECT 50
Offence related warrants
SECT
50. (1) An authorised person may apply to a magistrate for a warrant under
this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if the
magistrate is satisfied, by information on oath, that there are reasonable
grounds for suspecting that there is, or there may be within the next 72
hours, in or on the premises a particular thing (in this section called the
"evidence") that may afford evidence of the commission of an offence against
this Act.
(3) The magistrate must not issue the warrant unless the authorised person
or some other person has given to the magistrate, either orally or by
affidavit, such further information (if any) as the magistrate requires
concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) state the name of the authorised person; and
(b) authorise the authorised person, with such assistance and by such force
as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsection 48 (1); and
(iii) to seize the evidence; and
(c) state whether the entry is authorised to be made at any time of the day
or night or during specified hours of the day or night; and
(d) specify the day (not more than one week after the issue of the warrant)
on which the warrant ceases to have effect; and
(e) state the purpose for which the warrant is issued.
THERAPEUTIC GOODS ACT 1989 - SECT 51
Offence related warrants by telephone
SECT
51. (1) If, in an urgent case, an authorised person considers it necessary
to do so, the person may apply to a magistrate by telephone for a warrant
under section 50 in relation to premises.
(2) Before applying for the warrant, the person must prepare an information
of the kind mentioned in subsection 50 (2) in relation to the premises that
sets out the grounds on which the warrant is sought.
(3) If it is necessary to do so, the person may apply for the warrant before
the information is sworn.
(4) If the magistrate is satisfied:
(a) after having considered the terms of the information; and
(b) after having received such further information (if any) as the
magistrate requires concerning the grounds on which the issue of the warrant
is being sought;
that there are reasonable grounds for issuing the warrant, the magistrate may
complete and sign the same warrant that the magistrate would issue under
section 50 if the application had been made under that section.
(5) If the magistrate completes and signs the warrant:
(a) the magistrate must:
(i) tell the authorised person what the terms of the warrant are;
and
(ii) tell the person the day on which and the time at which the
warrant was signed; and
(iii) tell the authorised person the day (not more than one week
after the magistrate completes and signs the warrant) on which the warrant
ceases to have effect; and
(iv) record on the warrant the reasons for granting the warrant; and
(b) the person must:
(i) complete a form of warrant in the same terms as the warrant
completed and signed by the magistrate; and
(ii) write on the form the name of the magistrate and the day on
which and the time at which the warrant was signed.
(6) The person must also, not later than the day after the day of expiry or
execution of the warrant, whichever is the earlier, send to the magistrate:
(a) the form of warrant completed by the person; and
(b) the information referred to in subsection (2), which must have been duly
sworn.
(7) When the magistrate receives those documents, the magistrate must:
(a) attach them to the warrant that the magistrate completed and signed;
and
(b) deal with them in the way in which the magistrate would have dealt with
the information if the application had been made under section 50.
(8) A form of warrant duly completed under subsection (5) is authority for
any entry, search, seizure or other exercise of a power that the warrant
signed by the magistrate authorises.
(9) If:
(a) it is material, in any proceedings, for a court to be satisfied that an
exercise of a power was authorised by this section; and
(b) the warrant signed by the magistrate authorising the exercise of the
power is not produced in evidence;
the court must assume, unless the contrary is proved, that the exercise of the
power was not authorised by such a warrant.
(10) A reference in this Part to a warrant under section 50 includes a
reference to a warrant signed by a magistrate under this section.
THERAPEUTIC GOODS ACT 1989 - SECT 51A
SECT
51A.*2* * * * * * *
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
THERAPEUTIC GOODS ACT 1989 - SECT 52
Identity cards
SECT
52. (1) The Secretary is to ensure that each authorised person is issued
with an identity card that incorporates a recent photograph of the person.
(2) Where an authorised person enters premises otherwise than under a
warrant, the authorised person must, if requested to do so by any person at
those premises, produce his or her identity card for inspection by that
person.
(3) Where a person ceases to be an authorised person, the person must, as
soon as practicable after so ceasing, return the person's identity card to the
Secretary.
Penalty for an offence against this subsection: $100.
THERAPEUTIC GOODS ACT 1989 - SECT 53
Retention of material on withdrawal of applications
SECT
53. Where a person withdraws an application for registration or listing of
therapeutic goods or an application for a licence, the Department may retain
the application and any material submitted in connection with the application.
THERAPEUTIC GOODS ACT 1989 - SECT 54
Offences
SECT
54. (1) An offence against section 14, 15, 21 or 22A or subsection 20 (1) or
35 (1) or (2) is an indictable offence.
(2) In proceedings for an offence against section 14, a certificate by the
Secretary to the effect that:
(a) the Secretary did not consent to the importation, supply or export the
subject of the proceedings; or
(b) the Secretary consented to that importation, supply or export subject to
conditions specified in the certificate;
is prima facie evidence of the matters specified in the certificate.
(3) Where a court convicts a person of an offence against this Act in
relation to any therapeutic goods (other than an indictable offence), the
court may order that the goods be forfeited to the Commonwealth and, where
such an order is made, the goods become the property of the Commonwealth.
(4) Where goods are so forfeited, the Secretary may cause notice of the
forfeiture to be published in the Gazette.
(5) Goods forfeited under an order referred to in subsection (3) are to be
disposed of in such manner as the Secretary directs.
(6) A prosecution in respect of an indictable offence against this Act may
be commenced at any time within 2 years after the commission of the offence.
THERAPEUTIC GOODS ACT 1989 - SECT 55
Conduct by directors, servants and agents
SECT
55. (1) Where, in proceedings for an offence against this Act, it is
necessary to establish the state of mind of a body corporate in relation to
particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by a director, servant or agent of the
body corporate within the scope of his or her actual or apparent authority;
and
(b) that the director, servant or agent had the state of mind.
(2) Any conduct engaged in on behalf of a body corporate by a director,
servant or agent of the body corporate within the scope of his or her actual
or apparent authority is to be taken, for the purposes of a prosecution for an
offence against this Act, to have been engaged in also by the body corporate
unless the body corporate establishes that the body corporate took reasonable
precautions and exercised due diligence to avoid the conduct.
(3) Where, in proceedings for an offence against this Act, it is necessary
to establish the state of mind of a person other than a body corporate in
relation to particular conduct, it is sufficient to show that:
(a) the conduct was engaged in by a servant or agent of the person within
the scope of his or her actual or apparent authority; and
(b) the servant or agent had the state of mind.
(4) Any conduct engaged in on behalf of a person other than a body corporate
(in this subsection called the "employer ) by a servant or agent of the
employer within the scope of his or her actual or apparent authority is to be
taken, for the purposes of a prosecution for an offence against this Act, to
have been engaged in also by the employer unless the employer establishes that
he or she took reasonable precautions and exercised due diligence to avoid the
conduct.
(5) Where:
(a) a person other than a body corporate is convicted of an offence; and
(b) the person would not have been convicted of the offence if subsections
(3) and (4) had not been enacted;
the person is not liable to be punished by imprisonment for that offence.
(6) A reference in subsection (1) or (3) to the state of mind of a person
includes a reference to:
(a) the knowledge, intention, opinion, belief or purpose of the person; and
(b) the person's reasons for the intention, opinion, belief or purpose.
(7) A reference in this section to a director of a body corporate includes a
reference to a constituent member of a body corporate incorporated for a
public purpose by a law of the Commonwealth, of a State or of a Territory.
(8) A reference in this section to engaging in conduct includes a reference
to failing or refusing to engage in conduct.
(9) A reference in this section to an offence against this Act includes a
reference to:
(a) an offence against the regulations; and
(b) an offence created by section 6, 7 or 7A, or subsection 86 (1), of the
Crimes Act 1914, being an offence that relates to this Act or the regulations.
THERAPEUTIC GOODS ACT 1989 - SECT 56
Judicial notice
SECT
56. All courts are to take judicial notice of the British Pharmacopoeia and
of the British Pharmacopoeia (Veterinary).
THERAPEUTIC GOODS ACT 1989 - SECT 57
Delegation
SECT
57. (1) Subject to subsections (2) and (6), the Minister or the Secretary
may, by signed instrument, delegate to:
(a) an officer of the Department; or
(b) an officer of another Department or of an authority of the Commonwealth
that has functions in relation to therapeutic goods; or
(c) a person occupying or acting in an office, or holding an appointment,
declared by the regulations to be an office or appointment the occupant or
holder of which may be a delegate under this section;
all or any of his or her powers and functions under this Act.
(2) The powers of the Secretary under paragraph 19 (1) (a) may be delegated
under subsection (1) only to a person referred to in paragraph (1) (a) or (c)
who is registered, or eligible for registration, in a State or internal
Territory, as a medical or dental practitioner or as a pharmacist.
(3) Subject to the regulations, the Secretary may, in such circumstances as
are prescribed, by signed instrument, delegate all or any of his or her powers
under paragraph 19 (1) (a) to a person who is registered, in a State or
internal Territory, as a medical or dental practitioner.
(4) A delegate under subsection (3) is, in the exercise of a delegated
power, subject to the directions of:
(a) the Secretary; or
(b) an officer of the Department authorised in writing by the Secretary; or
(c) a person referred to in paragraph (1) (c).
(5) Without limiting the generality of matters that may be dealt with by
regulations made for the purposes of subsection (3), the regulations may make
provision in relation to the following:
(a) the persons who may be delegates;
(b) the circumstances in which delegates may grant approvals for the
purposes of paragraph 19 (1) (a);
(c) the conditions to which any approvals granted by delegates are to be
subject;
(d) requiring information to be given by delegates to the Secretary.
(6) The powers of the Secretary under subsection 19 (5) may be delegated
only to a person referred to in paragraph (1) (a) or (c) who is registered, or
eligible for registration, in a State or internal Territory as a medical or
dental practitioner.
(7) The regulations may prescribe the circumstances in which, and the
requirements subject to which, delegates may grant authorities under
subsection 19 (5).
THERAPEUTIC GOODS ACT 1989 - SECT 58
Export certifications
SECT
58. (1) The Secretary may issue export certification for goods for
therapeutic use in humans, including certifications for the purposes of the
World Health Organisation Certification Scheme on the Quality of
Pharmaceutical Products Moving in International Commerce.
(2) A State or Territory must not issue export certifications for goods for
therapeutic use in humans.
(3) Such fee as is prescribed is payable in respect of:
(a) an application for a certification under this section; and
(b) where an inspection of manufacturing premises is necessary for the
purposes of the issue of a certification under this section - the inspection
of those premises.
THERAPEUTIC GOODS ACT 1989 - SECT 59
Fees
SECT
59. (1) No fees are payable under this Act in respect of an event occurring
before 1 July 1990.
(2) Fees prescribed under this Act must not be such as to amount to
taxation.
(3) No licence or inspection fees are to apply to non-profit hospital supply
units.
THERAPEUTIC GOODS ACT 1989 - SECT 60
Review of decisions
SECT
60. (1) In this section:
"decision" has the same meaning as in the Administrative Appeals Tribunal
Act 1975;
"initial decision" means a decision of the Secretary or of a delegate of the
Secretary:
(a) under the definition of "therapeutic devices"in subsection 3 (1) or
under subsection 7 (1); or
(b) refusing to grant a consent under section 14; or
(c) under Part 3 or 4;
"reviewable decision" means a decision of the Minister under subsection (3).
(2) A person whose interests are affected by an initial decision may, by
notice in writing given to the Minister:
(a) in the case of a decision particulars of which are required to be
notified in the Gazette - within 90 days after those particulars are so
notified; or
(b) in any other case - within 90 days after the decision first comes to the
person's notice;
request the Minister to reconsider the decision.
(3) The Minister must, as soon as practicable after receiving a request
under subsection (2), reconsider the initial decision and, as a result of that
reconsideration, may:
(a) confirm the initial decision; or
(b) revoke the initial decision, or revoke that decision and make a decision
in substitution for the initial decision.
(4) Where a person who has made a request under subsection (2) does not
receive notice of the decision of the Minister on reconsideration within 60
days of the making of the request, the Minister is to be taken to have
confirmed the original decision.
(5) After reconsideration of an initial decision, the Minister must give the
applicant a notice in writing stating the result of the reconsideration and
that the applicant may, except where subsection 28 (4) of the Administrative
Appeals Tribunal Act 1975 applies, apply for a statement setting out the
reasons for the decision on reconsideration and may, subject to that Act, make
an application to the Administrative Appeals Tribunal for review of that
decision.
(6) Where written notice of the making of an initial decision is given to a
person whose interests are affected by the decision, the notice is to include
a statement to the effect that a person whose interests are affected by the
decision may:
(a) seek a reconsideration of the decision under this section; and
(b) subject to the Administrative Appeals Tribunal Act 1975, if the person
is dissatisfied with the decision upon reconsideration, make an application to
the Administrative Appeals Tribunal for review of that decision.
(7) Any failure to comply with the requirements of subsection (5) or (6) in
relation to a decision does not affect the validity of the decision.
(8) An application may be made to the Administrative Appeals Tribunal for
review of a reviewable decision.
THERAPEUTIC GOODS ACT 1989 - SECT 61
Release of information
SECT
61.*2* and*3* (1) In this section:
"therapeutic goods information" means information in relation to therapeutic
goods that came into the possession of the Department in connection with the
performance of the Department's functions.
(2) The Secretary may:
(a) release to the Director-General of the World Health Organisation
therapeutic goods information relating to:
(i) notifications concerning therapeutic goods the consumption or
supply of which in Australia has been prohibited or severely restricted, or
relating to the reasons for that action; or
(ii) the licensing status of Australian manufacturers of therapeutic
goods and their compliance with the manufacturing principles; or
(iii) the content of reports to the Department concerning adverse
effects of therapeutic goods;
for use in the development of policies relating to the regulation of
therapeutic goods or for the provision of information to regulatory
authorities of member countries of the World Health Organisation; or
(b) release, in confidence, therapeutic goods information to the
Director-General of the World Health Organisation, being information
concerning proceedings of committees established under the regulations.
(3) The Secretary may release to the head of an authority of the
Commonwealth, a State or a Territory that has functions relating to
therapeutic goods, therapeutic goods information relating to:
(a) reported problems and complaints concerning therapeutic goods, the
Department's investigation of those problems and complaints and any action
that the Department has taken or proposes to take in relation to those
problems and complaints; or
(b) reports of inspections conducted under this Act or the regulations; or
(c) decisions to revoke or suspend, or not to issue, licences for the
manufacturing of therapeutic goods; or
(d) conditions of licences; or
(e) reports of the testing of samples of therapeutic goods;
for use in the performance of those functions.
(4) The Secretary may release to the head of a national regulatory authority
of another country, being an authority that has national responsibility
relating to therapeutic goods, therapeutic goods information relating to:
(a) recommendations of advisory committees on therapeutic goods supplied in
or proposed for supply in Australia, and any conditions that are or will be
applicable to that supply; or
(b) decisions on the registration or listing, or the cancellation of the
registration or listing, of therapeutic goods; or
(c) the withdrawal from supply in Australia of therapeutic goods and the
reasons for that action; or
(d) the licensing status of Australian manufacturers of therapeutic goods
and their compliance with the manufacturing principles; or
(e) proceedings of committees established under the regulations;
for use in the performance of those functions or for furthering international
co-operation in the regulation of therapeutic goods.
(5) The Secretary may release to the head of a national regulatory authority
of another country, or the head of an international organisation, being
another country or an organisation with which the Commonwealth has
co-operative arrangements relating to the assessment or regulation of
therapeutic goods, therapeutic goods information the release of which is
consistent with those arrangements.
(6) The Secretary may release to a person, on application by that person,
therapeutic goods information of a kind identified in the regulations relating
to:
(a) therapeutic goods included in the Register; or
(b) therapeutic goods in relation to which an application for registration
or listing has been made.
(6A) Regulations made for the purposes of subsection (6) may:
(a) relate to therapeutic goods generally or to a class of such goods; and
(b) authorise the release of therapeutic goods information to persons
generally or to a class of persons; and
(c) authorise the release of information on application or otherwise.
(7) The Secretary may release therapeutic goods information:
(a) the release of which is necessary to ensure the safe use of particular
therapeutic goods; or
(b) relating to the reasons for the withdrawal of therapeutic goods from
supply in Australia.
(8) Therapeutic goods information provided to the Department in relation to
a matter may:
(a) be used by the Department in the consideration of another matter within
its functions relating to therapeutic goods; and
(b) be provided to a committee appointed to advise the Minister or the
Secretary on matters relating to therapeutic goods, including a committee of
the National Health and Medical Research Council.
(8A) Regulations prescribing fees in respect of applications for information
under the regulations:
(a) may include provision for the payment of deposits on account of such
fees; and
(b) may provide for fees that take into account the time spent by officers
of the Department in:
(i) searching for or retrieving information; or
(ii) making, or doing anything related to the making of, a decision
on an application; and
(c) may provide for fees that take into account the direct costs incurred by
the Commonwealth in making available an officer to supervise the inspection by
an applicant of any document containing information to which an application
relates.
(8C) If, under the regulations, a person is liable to pay a fee in respect
of an application for information, the Secretary must notify the person, in
writing, accordingly, and must give to the person, together with that
notification, a statement setting out the basis on which the amount of that
fee is calculated.
(9) Civil proceedings do not lie against the Secretary or a delegate of the
Secretary in respect of loss, damage or injury of any kind suffered by another
person as a result of the release of information in good faith under this
section or the regulations.
(10) This section has effect subject to the Freedom of Information Act 1982.
*2* Sections 3, 6, 6A-6C, 25, 26, 51A and 61 are amended by sections 29 (h),
(i), 30-32, 37 (b), 38 (b), 47 and 50 (1) (d) of the Health and Community
Services Legislation Amendment Act (No. 2) 1993, section 2 of which provides
as follows:
"2. (1) Subject to this section, this Act commences on the day on which it
receives the Royal Assent.
"(2) Paragraph 29 (h) and sections 30, 31 and 32 commence on a day to be
fixed by Proclamation.
"(3) Paragraphs 29 (i), 37 (b) and 38 (b), section 47 and paragraph 50 (1)
(d) commence on a day to be fixed by Proclamation.
"(4) The day fixed for the purposes of subsection (3) must not be earlier
than the day on which the Mutual Recognition Convention enters into force in
relation to Australia."
As at 14 January 1994 no date had been fixed for subsections (2)-(4) and
these amendments are not incorporated in this reprint. They are set out below
under the heading "EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION
AMENDMENT ACT (No. 2) 1993.
*3* Section 61 (8B) - Paragraph 88 (c) of the Health, Housing and Community
Services Legislation Amendment Act 1992 provides as follows:
"(c) by omitting from subsection (8A) under section (6)and substituting
under the regulations."
The proposed amendment was misdescribed and is not incorporated in this
reprint.
THERAPEUTIC GOODS ACT 1989 - SECT 62
Consequential amendments
SECT
62. The Acts specified in the Schedule are amended as set out in the
Schedule.
THERAPEUTIC GOODS ACT 1989 - SECT 63
Regulations
SECT
63. (1) The Governor-General may make regulations, not inconsistent with
this Act, prescribing matters:
(a) required or permitted to be prescribed by this Act; or
(b) necessary or convenient to be prescribed for carrying out or giving
effect to this Act.
(2) The regulations may:
(a) make provision in relation to:
(i) the establishment of committees to advise the Minister or the
Secretary on matters relating to therapeutic goods; and
(ii) the functions and powers of those committees; and
(iii) the payment of remuneration and allowances to members of those
committees; and
(b) prescribe requirements for the storage and transport of therapeutic
goods; and
(c) prescribe requirements for the advertising of therapeutic goods; and
(d) provide for the procedures to be followed by the Department in the
sampling and testing of therapeutic goods; and
(da) provide for the periods within which evaluations under section 25 in
relation to specified therapeutic goods or specified classes of such goods are
to be completed;
(e) prescribe requirements for informational material that is included with
therapeutic goods; and
(f) make provision for the transfer of registration or listing of
therapeutic goods and of licences; and
(g) make provision for the testing of therapeutic goods, the inspection of
manufacturing operations or the evaluation of data concerning therapeutic
goods by the Department at the request of persons; and
(h) prescribe fees in respect of matters under this Act or the regulations;
and
(j) prescribe penalties not exceeding $1,000 for offences against the
regulations.
(3) The regulations may:
(a) prescribe different fees under this Act in relation to:
(i) different classes of goods; or
(ii) in the case of fees under Part 4 - different steps in the
manufacture of goods; or
(b) provide for the refund, reduction or waiving of fees or charges in cases
identified in the regulations; or
(c) specify the type of information relating to therapeutic goods
manufactured by licence holders that the Secretary may, under subsection 37
(2), require to be supplied by the holders of licences at the time of payment
of annual licensing charges in respect of the licences.
(4) The regulations may make provision for a matter by applying, adopting or
incorporating, with or without modification, any matter contained in an
instrument:
(a) as that instrument is in force at the time when the regulations take
effect; or
(b) as that instrument is in force from time to time.
(5) For the purposes of section 2, regulations may be made before the
commencement of this Act as if this Act were in force, but do not come into
effect on a day earlier than the day on which this Act commences.
THERAPEUTIC GOODS ACT 1989 - PART 7
PART 7 - REPEAL AND TRANSITIONAL PROVISIONS
THERAPEUTIC GOODS ACT 1989 - SECT 64
Interpretation
SECT
64. In this Part, "former Act" means the Therapeutic Goods Act 1966.
THERAPEUTIC GOODS ACT 1989 - SECT 65
Repeal
SECT
65. The former Act is repealed.
THERAPEUTIC GOODS ACT 1989 - SECT 66
Transitional arrangements for goods required to be registered or listed
SECT
66. (1) This section applies to therapeutic goods in relation to a person
if, immediately before the commencement of this Act, the person was supplying
goods of that kind in Australia for use in humans.
(2) Where:
(a) this section applies to therapeutic goods in relation to a person; and
(b) the Secretary is not aware of the person having been convicted of an
offence against a law of the Commonwealth, of a State or of an internal
Territory in respect of goods of that kind during the period of 2 years ending
on the commencement of this Act; and
(c) if the goods are imported goods - the Secretary is not aware of the
person having, during that period, imported goods of that kind into Australia
otherwise than in accordance with regulations in force under the Customs Act
1901;
subsections 20 (1) and (2) do not apply to goods of that kind in relation to
the person during the period of 3 months after that commencement.
(3) Where:
(a) this section applies to therapeutic goods in relation to a person; and
(b) the person makes an application for registration or listing of goods of
that kind in accordance with section 23 and within 3 months after the
commencement of this Act;
then:
(c) subsection 20 (1) does not apply to goods of that kind in relation to
the person during the period of 6 months after that commencement or before the
end of such longer period as the Secretary specifies by notice published in
the Gazette before the end of that first-mentioned period; and
(d) subsection 20 (2) does not apply to goods of that kind in relation to
the person during the period of 12 months after that commencement or before
the end of such longer period as the Secretary specifies by notice published
in the Gazette before the end of that first-mentioned period.
(3A) If, on an application under subsection (3), goods have been registered
without having been evaluated, the Secretary may, if he or she thinks it
appropriate, give the person in relation to whom the goods are registered
written notice that the goods are to be evaluated to determine whether they
should continue to be registered.
(4) A person who makes an application in accordance with subsection (3) is
not required to pay:
(a) any application fee for the registration or listing of the goods to
which the application relates; or
(b) in the case of an application for the registration of goods - any fee
for the evaluation of the goods for registration;
but where the goods are later evaluated to determine whether the goods should
continue to be registered, such fee as is prescribed is payable in respect of
that evaluation.
(4A) In relation to an evaluation conducted for the purposes of this
section:
(a) section 25 has effect as if:
(i) the person in respect of whom the goods are registered were an
applicant for the registration of the goods; and
(ii) the reference in paragraph (1) (b) to an evaluation fee under
section 24 were a reference to a fee payable under subsection (4) of this
section; and
(b) sections 24A, 24B and 24C have effect as if any reference in those
sections to section 24 were a reference to subsection (4) of this section;
and
(c) sections 24D and 24E do not apply.
(4B) If, on an application under subsection (3), goods have been listed
without consideration of the matters mentioned in paragraphs 26 (1) (c) to
(m), the Secretary may, if he or she thinks it appropriate, give the person in
relation to whom the goods are listed written notice that the Secretary
intends to determine whether the goods should continue to be listed.
(4C) If notice is given under subsection (4B), section 26 applies as if the
person in relation to whom the goods are listed were an applicant for the
listing of the goods.
(5) Section 21 does not apply, during the period of 15 months after the
commencement of this Act or during such longer period as the Secretary
specifies by notice published in the Gazette before the end of that
first-mentioned period, to any goods.
(6) Where a person suffers any kind of loss, damage or injury caused by, or
arising out of, the use by the person of therapeutic goods to which this
section applies, no liability in respect of that loss, damage or injury
attaches to the Commonwealth, the Secretary or any delegate of the Secretary.
THERAPEUTIC GOODS ACT 1989 - SECT 67
Transitional provision for therapeutic goods for export only
SECT
67. Section 20 does not apply, during the period of 6 months after the
commencement of this Act, to therapeutic goods manufactured in Australia
solely for export from Australia.
THERAPEUTIC GOODS ACT 1989 - SECT 68
Transitional arrangements for Part 4
SECT
68. (1) This section applies to a step in the manufacture of therapeutic
goods in relation to a person in relation to premises in Australia if, before
the commencement of this Act, the person was carrying out that step in
relation to goods of that kind at those premises.
(2) Where:
(a) this section applies to a step in the manufacture of therapeutic goods
in relation to a person in relation to premises; and
(b) the Secretary is not aware of the person having been convicted of an
offence against a law of the Commonwealth, of a State or of an internal
Territory in respect of goods of that kind during the period of 2 years ending
on the commencement of this Act;
subsection 35 (1) does not apply the carrying out of that step by the person
in relation to goods of that kind at those premises during the period of 4
months after that commencement.
(3) Where:
(a) this section applies to a step in the manufacture of therapeutic goods
in relation to a person in relation to premises; and
(b) the person makes an application for a licence to carry out that step in
relation to goods of that kind at those premises in accordance with section 37
and within 4 months after the commencement of this Act;
subsection 35 (1) does not apply to the carrying out of that step by the
person in relation to goods of that kind at those premises until the
application is determined.
THERAPEUTIC GOODS ACT 1989 - SECT 69
Continuation of standards and requirements
SECT
69. Any standards that were in force immediately before the commencement of
this Act under Part 2 of the former Act, and any requirements that were in
force at that time under section 15 of the former Act, continue in force as if
they were standards made under Part 2 of this Act.
THERAPEUTIC GOODS ACT 1989 - SCHEDULE
SCH
SCHEDULE Section 62
CONSEQUENTIAL AMENDMENTS
Agricultural and Veterinary Chemicals Act 1988.*4*
* * * * *
Commonwealth Serum Laboratories Act 1961.*5*
* * * * *
Sea Installations Act 1987.*6*
* * * * *
*4* Section 62 - The amendment made by section 62 has been incorporated in the
reprint of the Agricultural and Veterinary Chemicals Act 1988 which is
published separately.
*5* Section 62 - The amendments made by section 62 have been incorporated in
the reprint of the Commonwealth Serum Laboratories Act 1961, which is
published separately.
*6* Section 62 - The amendments made by section 62 have been incorporated in
the reprint of the Sea Installations Act 1987, which is published separately.
THERAPEUTIC GOODS ACT 1989 - EXTRACT
SECT
EXTRACTS FROM HEALTH AND COMMUNITY SERVICES LEGISLATION AMENDMENT
ACT (No. 2) 1993
29. Section 3 of the Principal Act is amended:
(h) by inserting in subsection (1) the following definitions:
"corresponding State law means a State law declared by the regulations to
correspond to this Act or the regulations, including such a law as amended
from time to time;
"State law means a law of a State, of the Australian Capital Territory or of
the Northern Territory;";
(i) by inserting in subsectin (1) the following definition:
"Mutual Recognition Convention" means the Convention for the Mutual
Recognition of Inspections in respect of the Manufacture of Pharmaceutical
Products done at Geneva on 8 October 1970;".
30. Section 4 of the Principal Act is repealed and the following section is
substituted:
"4. (1) The object of this Act is to promote the development of a national
system of controls relating to the quality, safety, efficacy and timely
availability of therapeutic goods used in Australia or exported from
Australia, whether the goods are produced in Australia or elsewhere.
"(2) The provisions made by this Act are intended, as far as the
Constitution permits, to impose those controls forming part of the national
system that are appropriate to be imposed by legislation of the Commonwealth.
"(3) It is the intention of the Parliament that the other controls forming
part of the national system be imposed by the laws of the States, of the
Australian Capital Territory and of the Northern Territory.
"(4) This Act is therefore not intended to apply to the exclusion of a law
of a State, of the Australian Capital Territory or of the Northern Territory
to the extent that the law is capable of operating concurrently with this
Act.". Operation of Act
31. Section 6 of the Principal Act is amended by omitting subsection (3).
32. After section 6 of the Principal Act the following sections are
inserted: State and Territory functions and powers of Secretary
"6A. (1) If a corresponding State law confers a function or power on the
Secretary, the Secretary may, with the written approval of the Minister,
perform the function or exercise the power, as the case may be.
"(2) While an approval is in force for the purpose of subsection (1):
(a) subsection 39 (6) of the Public Service Act 1922 has effect as if a
function or power to which the approval relates were a function or power of
the Secretary under this Act; and
(b) section 57 of this Act has effect as if such a function or power were a
function or power under this Act.
"(3) If:
(a) a corresponding State law is expressed to confer on the Secretary:
(i) the function of including goods in the Register; or
(ii) the power to include goods in the Register; and
(b) an approval under subsection (1) is in force in relation to the function
or power;
the Secretary may include the goods in the Register in accordance with the
State law.
"(4) If a corresponding State law is expressed to authorise or require the
Secretary to cancel the inclusion of goods in the Register, the Secretary may
cancel the inclusion of the goods in the Register in accordance with State
law.
"(5) The inclusion of goods in the Register under subsection (3) does not
subject any person to any liability whatever under this Act, except a
liability under Part 5.
"(6) The Secretary may make any notations in the Register that he or she
thinks necessary to identify entries that relate to goods included in the
Register under subsection (3).
"(7) Goods may be included in the Register under subsection (3) even though
the same goods have already been included in the Register under another
provision of this Act.
"(8) A reference in this section to the inclusion of goods in the Register
is a reference to the inclusion of the goods:
(a) in the part of the Register for goods known as registered goods; or
(b) in the part of the Register for goods known as listed goods. Review of
certain decisions under State laws
"6B. (1) Application may be made to the Administrative Appeals Tribunal for
review of a reviewable State decision.
"(2) A decision made by the Secretary in the performance of a function, or
the exercise of a power, conferred by a corresponding State law is a
reviewable State decision for the purpose of this section if:
(a) the law under which the decision was made provides for review by the
Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable decision
for the purposes of this section.
"(3) For the purposes of subsection (1), the Administrative Appeals Tribunal
Act 1975 has effect as if a corresponding State law were an enactment. Fees
payable to Commonwealth under State laws
"6C. (1) This section applies to fees payable to the Commonwealth under a
State law in respect of the performance or exercise of functions or powers
conferred by that law on the Secretary.
"(2) The Secretary may make arrangements with the appropriate authority of a
State, of the Australian Capital Territory or of the Northern Territory in
relation to the payment to the Commonwealth of fees to which this section
applies.". Evaluation of therapeutic goods
37. Section 25 of the Principal Act is amended:
(b) by inserting after subsection (2D) the following subsections:
"(2E) A decision for the purposes of paragraph (1) (g) may also take into
account any information provided to the Secretary by a health authority of a
Convention country and relating to:
(a) the general standards of manufacturing practice of a particular
manufacturer; or
(b) the specific standards of manufacture or control adopted by a particular
manufacturer in relation to particular goods.
"(2F) For the purposes of subsection (2E), a Convention country is a country
that is a party to the Mutual Recognition Convention. Listing of therapeutic
goods
38. Section 26 of the Principal Act is amended:
(b) by inserting after subsection (2C) the following subsections:
47. After section 51 of the Principal Act the following section is inserted:
Searches at request of manufacturer
"51A. (1) A person may request the Secretary to arrange for an authorised
person to inspect premises, and specified processes being carried out on those
premises, for the purposes of paragraph 2 of Article 3 of the Mutual
Recognition Convention.
"(2) An authorised person may make an inspection in accordance with
arrangements under subsection (1).". Release of information
50. (1) Section 61 of the Principal Act is amended:
(d) by omitting subsection (10) and substituting the following subsections:
"(10) Nothing in this or any other Act requires the Secretary to disclose to
any person, court or tribunal information referred to in subsection 25 (2E) or
26 (2D) if the disclosure would constitute a breach of the Mutual Recognition
Convention.
"(11) This section (except subsection (10)) has effect subject to the
Freedom of Information Act 1982.".