Part 1
PRELIMINARY
CHAPTER 1—PRELIMINARY
1. Citation
2. Interpretation
3. State or Territory Laws that continue to apply
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
These Regulations set out how the Therapeutic Goods Act works in practice. They define key terms, prescribe which products must be registered, listed or are exempt, impose advertising prohibitions, require manufacturing licences and record-keeping, empower authorised officers to sample and analysts to test goods, establish advisory committees, and set fees and review procedures. Sponsors and licence-holders generally pay fees and must meet labelling, testing and record-keeping obligations; the Secretary and Minister hold decision-making and discretionary powers that trigger compliance duties.
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Direct links to the current provisions in Therapeutic Goods Regulations.
CHAPTER 1—PRELIMINARY
1. Citation
2. Interpretation
3. State or Territory Laws that continue to apply
CHAPTER 2 ADVERTISEMENTS
4. This Chapter not to apply to advertisements directed at health professionals etc.
5. This Chapter not to apply to advertisements for goods not for human use
6. Advertising offences
7. Certain representations not to be published
8. Prohibited and required representations
9. Use of prohibited representations
CHAPTER 3—REGISTRATION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS
10. Registered goods
11. Listed goods
12. Exempt goods
13. Change of name in which goods are registered or listed
14. Transfers within the Register
15. Application of registration or listing numbers to goods
16. Listing of certain therapeutic devices
CHAPTER 4—LICENSING OF MANUFACTURERS
17. Exempt goods for the purposes of subsection 34 (1) of the Act
18. Exempt persons
19. Requirements for licence holders
20. Conditions of licences
21. Persons having control of production etc. to be named
22. Transfer of licences
Regulation
CHAPTER 5—EXAMINATION, TESTING AND ANALYSIS OF GOODS
23. Interpretation
24. Authorised officer—powers and duties
25. Appointment of official analysts
26. Taking of samples for testing
27. Examination and testing by official analyst
28. Relevant tests
29. Certificate of official analyst
30. Review of findings of official analyst
31. Payment for samples
32. Offences relating to analysis etc.
33. Identity cards
CHAPTER 6—COMMITTEES
34. Therapeutic Goods Committee
35. Therapeutic Device Evaluation Committee
36. Australian Drug Evaluation Committee
37. Minister or Secretary may seek further advice
38. Tenure of office of members
39. Disclosure of interests
40. Acting members
41. Meetings of Committees
42. Effect of vacancy on Committee
CHAPTER 7—FEES AND COSTS
43. Fees
44. Testing of samples—recovery of costs
45. Waiver or reduction of fees
CHAPTER 8—MISCELLANEOUS
46. Release of information
47. Delegation
48. Review of decisions
SCHEDULE 1
PROHIBITED AND REQUIRED REPRESENTATIONS FOR THE PURPOSES OF PARAGRAPHS 6 (a) AND (b)
SCHEDULE 2
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR REGISTERED GOODS
SCHEDULE 3
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR LISTED GOODS
SCHEDULE 4
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3 OF THE ACT
SCHEDULE 5
THERAPEUTIC DEVICES PRESCRIBED FOR THE PURPOSES OF PARAGRAPH 26 (l) (g) OF THE ACT
SCHEDULE 6
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT UNLESS SUPPLIED AS PHARMACEUTICAL BENEFITS
SCHEDULE 7
PERSONS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Statutory Rules 1990 No. 88
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Therapeutic Goods Regulations
TABLE OF PROVISIONS
Regulation
CHAPTER 1—PRELIMINARY
1. Citation
2. Interpretation
3. State or Territory Laws that continue to apply
CHAPTER 2 ADVERTISEMENTS
4. This Chapter not to apply to advertisements directed at health professionals etc.
5. This Chapter not to apply to advertisements for goods not for human use
6. Advertising offences
7. Certain representations not to be published
8. Prohibited and required representations
9. Use of prohibited representations
CHAPTER 3—REGISTRATION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS
10. Registered goods
11. Listed goods
12. Exempt goods
13. Change of name in which goods are registered or listed
14. Transfers within the Register
15. Application of registration or listing numbers to goods
16. Listing of certain therapeutic devices
CHAPTER 4—LICENSING OF MANUFACTURERS
17. Exempt goods for the purposes of subsection 34 (1) of the Act
18. Exempt persons
19. Requirements for licence holders
20. Conditions of licences
21. Persons having control of production etc. to be named
22. Transfer of licences
Regulation
CHAPTER 5—EXAMINATION, TESTING AND ANALYSIS OF GOODS
23. Interpretation
24. Authorised officer—powers and duties
25. Appointment of official analysts
26. Taking of samples for testing
27. Examination and testing by official analyst
28. Relevant tests
29. Certificate of official analyst
30. Review of findings of official analyst
31. Payment for samples
32. Offences relating to analysis etc.
33. Identity cards
CHAPTER 6—COMMITTEES
34. Therapeutic Goods Committee
35. Therapeutic Device Evaluation Committee
36. Australian Drug Evaluation Committee
37. Minister or Secretary may seek further advice
38. Tenure of office of members
39. Disclosure of interests
40. Acting members
41. Meetings of Committees
42. Effect of vacancy on Committee
CHAPTER 7—FEES AND COSTS
43. Fees
44. Testing of samples—recovery of costs
45. Waiver or reduction of fees
CHAPTER 8—MISCELLANEOUS
46. Release of information
47. Delegation
48. Review of decisions
SCHEDULE 1
PROHIBITED AND REQUIRED REPRESENTATIONS FOR THE PURPOSES OF PARAGRAPHS 6 (a) AND (b)
SCHEDULE 2
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR REGISTERED GOODS
SCHEDULE 3
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF THE REGISTER FOR LISTED GOODS
SCHEDULE 4
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3 OF THE ACT
SCHEDULE 5
THERAPEUTIC DEVICES PRESCRIBED FOR THE PURPOSES OF PARAGRAPH 26 (l) (g) OF THE ACT
SCHEDULE 6
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT UNLESS SUPPLIED AS PHARMACEUTICAL BENEFITS
SCHEDULE 7
PERSONS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT
SCHEDULE 8
FEES
Statutory Rules 1990 No. 881
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Therapeutic Goods Regulations
I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council and under section 4 of the Acts Interpretation Act 1901, hereby make the following Regulations under the Therapeutic Goods Act 1989.
Dated 1 May 1990.
BILL HAYDEN
Governor-General
By His Excellency's Command,
B. HOWE
Minister of State for Community Services and Health
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CHAPTER 1—PRELIMINARY
Citation
Interpretation
"analysis" includes examination and testing;
"antiseptic" means a substance that is intended for application on the body or the mucous membranes of a person or an animal
to kill or prevent the growth of a broad range of micro organisms, and that is:
(a) not represented to be suitable for internal use; and
(b) not capable of inducing resistance in micro organisms to other anti-infective agents;
"diagnostic goods for in vitro use" means a reagent, instrument or system that is intended to be used in the examination of specimens taken from the body of a person or animal in connection with the diagnosis of a disease, ailment or defect in, or injury to, a person or animal or the monitoring of a condition in a person or animal;
"disinfectant" means a substance that is intended for application to inanimate objects to kill a broad range of micro organisms, and that is:
(a) not represented to be suitable for the internal use in, or dermal use on, a person or an animal; and
(b) not capable of inducing resistance in micro organisms to other anti-infective agents;
"drugs" means:
(a) therapeutic goods that are represented to achieve, or are likely to achieve, any of the principal purposes of their use as a result of chemical action in or on the body of a person or animal; and
(b) any other therapeutic goods declared by the Secretary, by notice published in the Gazette, not to be therapeutic devices;
"herbal substance" means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, glycerin or aqueous ethanol; and
(b) that is not subjected to any treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form;
"homoeopathic preparation" means a preparation:
(a) formulated on the principle of medication by extremely small doses of a substance of plant, animal or mineral origin that has the property of producing in a healthy person or animal the symptoms or conditions manifested by a disease; and
(b) made using the methods of serial dilution and succussion;
"immediate family", in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person;
"implantable", in relation to a therapeutic device, means designed to be implanted into the tissues or body cavities of a person or animal, other than the teeth, for a period of 30 days or more;
"mother tincture" means a preparation prepared by the process of solution, extraction or trituration for dilution in powers of 10 to prepare homoeopathic preparations;
"official analyst" means a person approved by the Secretary under regulation 25;
"pharmaceutical benefit" means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986;
"poison" means a substance or preparation that is included in a Schedule to the Poisons Standard;
"Poisons Standard" means the current edition of the Standard for the uniform scheduling of drugs and poisons published by the National Health and Medical Research Council;
"prohibited representation" means a representation referred to in subregulation 8(1);
"required representation" means a representation referred to in subregulation 8 (2);
"sample" includes part of a sample;
"the Act" means the Therapeutic Goods Act 1989.
State or Territory laws that continue to apply
(a) laws of the State of New South Wales:
(i) the Therapeutic Goods and Cosmetics Act 1972;
(ii) the Therapeutic Goods and Cosmetics Regulations;
(iii) the Poisons Act 1966;
(iv) the Poisons Regulations;
(b) laws of the State of Victoria:
(i) the Health Act 1958;
(ii) the Health (Proprietary Medicines) Regulations 1984;
(iii) the Drugs, Poisons and Controlled Substances Act 1981;
(iv) the Drugs, Poisons and Controlled Substances Regulations 1985;
(c) laws of the State of Queensland:
(i) the Health Act of 1937-1989;
(ii) the Poisons Regulations of 1973;
(iii) the Therapeutic Goods and Other Drugs Regulations 1982;
(d) laws of the State of South Australia:
(i) the Drugs Act, 1908;
(ii) the Controlled Substances Act, 1984;
(e) laws of the State of Western Australia:
(i) the Health Act 1911;
(ii) the Health (Drugs and Allied Substances) Regulations 1987;
(iii) the Poisons Act 1964;
(iv) the Poisons Regulations 1965;
(f) laws of the State of Tasmania:
(i) the Poisons Act 1971;
(ii) the Poisons Regulations;
(iii) the Poisons List Order 1984;
(g) the Therapeutic Goods and Cosmetics Act 1986 of the Northern Territory of Australia;
(h) laws of the Australian Capital Territory:
(i) the Public Health (Prohibited Drugs) Act 1957;
(ii) the Public Health (Sale of Food and Drugs) Regulations.
CHAPTER 2—ADVERTISEMENTS
This Chapter not to apply to advertisements directed at health professionals etc.
(a) medical practitioners, dentists, veterinary surgeons, pharmacists, physiotherapists or nurses; or
(b) persons who are engaged in the business of wholesaling therapeutic goods.
This Chapter not to apply to advertisements for goods not for human use
Advertising offences
(a) that contains a prohibited representation about those goods; or
(b) that does not contain a required representation about those goods; or
(c) that is in contravention of a notice referred to in regulation 7 or 9:
(i) that was served on that person; or
(ii) of which the person was aware when the advertisement was published; or
(d) that contains:
(i) a reference to the Act, other than in relation to the registration number or listing number of the goods; or
(ii) a statement suggesting or implying that the goods have been recommended or approved by or on behalf of a government or government authority, other than a statement of their availability as a pharmaceutical benefit; or
(e) that refers to goods included in Schedule 3,4 or 8 to the Poisons Standard; or
(f) that are not registered or listed, unless the goods are exempt goods.
Penalty: $1,000.
Certain representations not to be published
Prohibited and required representations
(2) For the purposes of paragraph 6 (b), a representation specified in column 2 of an item in Part 2 of Schedule 1 is a required representation about the therapeutic goods specified in column 3 of that item.
Use of prohibited representations
CHAPTER 3—REGISTRATION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS
Registered Goods
Listed Goods
Exempt Goods
Change of name in which goods are registered or listed
13. (1) If a person in relation to whom therapeutic goods are registered or listed dies, the legal personal representative of the dead person:
(a) is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the death.
(2) If a person in relation to whom therapeutic goods are registered or listed becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the bankruptcy.
(3) If a body corporate in relation to which therapeutic goods are registered or listed is being wound up, the liquidator of the body corporate:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business is to include a transfer of the registration or listing of therapeutic goods;
then:
(c) the person who acquires that business is to be taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(d) that person must, as soon as practicable after the transfer, inform the Secretary that the person has, by reason of that agreement, become the person in relation to whom the goods are to be registered or listed.
(5) When a person notifies the Secretary of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) If the Secretary is informed of the transfer of registration or listing of any therapeutic goods in accordance with this regulation, the Secretary must amend the Register accordingly.
(7) If, at any time, the Secretary becomes aware that he or she has not been informed of the transfer of registration or listing in respect of any therapeutic goods in accordance with this regulation, the Secretary may cancel the registration or listing of those goods.
(8) As soon as practicable after the Secretary has amended the Register in accordance with subregulation (6), the Secretary must give to the person in whose name the goods are registered or listed a certificate of registration or listing of the goods.
(9) If the Secretary:
(a) amends the Register in accordance with subregulation (6); or
(b) cancels the registration or listing of goods under subregulation (7);
the person who has the certificate issued under subsection 25 (4) or 26 (4) of the Act or subregulation (8) must return it as soon as practicable to the Secretary.
Penalty: $100.
Transfers within the Register
14. (1) If goods that are included in the part of the Register for listed goods become subject to inclusion in the part of the Register for registered goods, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry in relation to the goods to the part of the Register for registered goods.
(2) An application under subregulation (1) must be made:
(a) if the Secretary notifies the person in whose name the goods
are entered in the Register of a period within which the application must be made—within that period; or
(b) in any other case—not later than 15 months after the day on which the goods became subject to inclusion in the part of the Register for registered goods.
Penalty: $1,000.
(3) In determining a period of notice for the purpos
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