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Therapeutic Goods Act 1989

  • - C2004C07569
  • In force - Superseded Version
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Act No. 21 of 1990 as amended, taking into account amendments up to Act No. 76 of 1993
Registered 08 Dec 2009
Start Date 25 Nov 1993
End Date 13 Feb 1994

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ad=added or inserted am=amended rep=repealed rs=repealed and substituted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*
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Commonwealth Serum Laboratories Act 1961.*5*
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Sea Installations Act 1987.*6*
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*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.".