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Therapeutic Goods Regulations

SR 1990 No. 88 Regulations as made
Principal Regulations
Made 01 May 1990
Tabled HR 09 May 1990
Tabled Senate 08 May 1990
Gazetted 04 May 1990
Date of repeal 16 May 1990
Repealed by Disallowed by the Senate on 16 May 1990.

1990 No. 88*1* THERAPEUTIC GOODS REGULATIONS
These Regulations were disallowed by the Senate on 16 May 1990

*1* Notified in the Commonwealth of Australia Gazette on 4 May 1990.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - TABLE OF PROVISIONS

TABLE

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 Certain representations not to be published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
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(1)(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

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 1 CHAPTER 1-PRELIMINARY

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 1
Citation

1. These Regulations may be cited as the Therapeutic Goods Regulations.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 2
Interpretation

2. In these Regulations, unless the contrary intention appears:
"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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 3
State or Territory laws that continue to apply

3. For the purposes of subsection 6 (3) of the Act, the following laws are identified:
(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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 2 CHAPTER
2-ADVERTISEMENTS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 4
This Chapter not to apply to advertisements directed at health
professionals etc.

4. This Chapter does not apply to advertisements directed exclusively to:
(a) medical practitioners, dentists, veterinary surgeons, pharmacists, physiotherapists or nurses; or
(b) persons who are engaged in the business of wholesaling therapeutic goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 5
This Chapter not to apply to advertisements for goods not for human use

5. This chapter does not apply to advertisements in respect of goods that are not for use in humans.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 6
Advertising offences

6. A person must not publish an advertisement about therapeutic goods:
(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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 7
Certain representations not to be published

7. If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to the person apparently responsible for publishing the advertisement, prevent that person from publishing, or causing to be published an advertisement containing that representation (whether express or implied) about those goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 8
Prohibited and required representations

8. (1) For the purposes of paragraph 6 (a), the representations specified in column 2 of an item in Part 1 of Schedule 1 are prohibited representations about the therapeutic goods specified in column 3 of that item.

(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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 9
Use of prohibited representations

9. The Secretary may, by notice published in the Gazette, permit a prohibited representation to be included on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 3 CHAPTER
3-REGISTRATION, LISTING AND EXEMPTION OF THERAPEUTIC GOODS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 10
Registered Goods

10. For the purpose of paragraph 17 (4) (a) of the Act, the therapeutic goods, or classes of therapeutic goods, specified in Schedule 2 must be included in the part of the Register for registered goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 11
Listed Goods

11. For the purposes of paragraph 17 (4) (a) of the Act, the therapeutic goods, or classes of therapeutic goods, specified in Part 1 of Schedule 3 must be included in the part of the Register for listed goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 12
Exempt Goods

12. For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in Schedule 4 are exempt from the operation of Part 3 of the Act.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 13
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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 14
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 purposes of paragraph (2) (a) the Secretary is to have regard to:
(a) the ability of the person in whose name the goods are entered in
the Register to provide the information necessary to support the transfer of the entry; and
(b) the reasons for the transfer in relation to the protection of
the public.

(4) It is not an offence for the sponsor of goods to which subregulation (1) applies to import, export, supply or manufacture the goods as listed goods until the time for making the application under subregulation (2) has expired or, if an application is made, until it is determined, whichever is the later.

(5) If goods that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:
(a) to transfer the entry in relation to the goods to the part of
the Register for listed goods; or
(b) to retain the entry in the part of the Register for registered
goods.
(6) An application to transfer an entry in relation to goods from one part of the Register to the other is to be treated as an application for registration or listing of the goods, as the case requires.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 15
Application of registration or listing number to goods

15. For the purposes of paragraph 20(2)(d) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:
(a) in the case of a therapeutic device included in the part of the Register for registered goods-by writing the number so that it is clearly visible to the user:
(i) on the label on the device; or
(ii) on the label on the outermost level of packaging in which the
device is to be supplied to its user;
and, where more than one device is packaged for supply together, on the label on the outermost surface of the outermost package; and
(b) in the case of drugs-by writing the number on the label on the container of the drugs, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and
(c) in each case-by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:

(i) "AUST R" in the case of registered goods; and
(ii) "AUST L" in the case of listed goods;
the numbers and letters in each case being not less than 1 millimetre in height.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 16
Listing of certain therapeutic devices

16. For the purposes of paragraph 26 (1) (g) of the Act, the therapeutic devices specified in Schedule 5 are prescribed.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 4 CHAPTER
4-LICENSING OF MANUFACTURERS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 17
Exempt goods for the purposes of subsection 34 (1) of the Act

17. For the purposes of subsection 34 (1) of the Act, the therapeutic goods specified in Schedule 6 are exempt from the operation of Part 4 of the Act unless the goods are supplied as pharmaceutical benefits.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 18
Exempt Persons

18. For the purposes of subsection 34 (2) of the Act, the persons specified in column 2 of an item in Schedule 7 are exempt from the operation of Part 4 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 19
Requirements for licence holders

19. For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:

(a) if the Secretary so requests-details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and
(b) details of persons nominated by the licence holder as having control of:
(i) the production of the goods; and
(ii) the quality control measures that are to be employed in the
manufacture of the goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 20
Conditions of licences

20. For the purposes of section 40 of the Act, the following are conditions to which each licence is subject:
(a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;
(b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:
(i) keep records showing:
(A) the materials used in the manufacture of the goods, the
supplier and quantities of the materials used and details of the tests performed on those materials; and
(B) the procedures and controls employed in the manufacture of
the goods, including the results of tests carried out during the processing of the goods; and
(C) details of the tests performed on the goods and the results
of those tests; and
(D) the stability studies (if any) that validate the
recommended shelf life and appropriate storage conditions of the goods; and
(ii) where
the goods to which the licence relates are produced in identifiable batches:
(A) assign a batch number to each batch of the goods; and
(B) if it is not unreasonable in the circumstances-retain at
those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and
(iii) retain those records at the licensed premises for at least 12
months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and
(iv) ensure that the persons nominated by the licence holder as
having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control;
(c) the licence holder must comply with the provisions of Chapter 5 in relation to the taking of samples by authorised officers.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 21
Persons having control of production etc. to be named

21. If:
(a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and
(b) the licence is granted; and
(c) the applicant wishes to replace the nominated person with another person;
then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 22
Transfer of licences

22. (1) If a person who was the holder of a licence dies the legal personal representative of the dead person:
(a) is to be taken to be the holder of the licence; and
(b) must, as soon as practicable, notify the Secretary, in writing, of the death.

(2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is to be taken to be the holder of the licence; and
(b) must, as soon as practicable, notify the Secretary, in writing,
of the bankruptcy.
(3) If a body corporate that is the holder of a licence is being wound up, the liquidator of the body corporate:
(a) is taken to be the holder of the licence; 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 a licence held by that person;
then:
(c) the person who acquires that business is to be taken to be the
holder of the licence; 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 an applicant for the licence.

(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) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1) (b), (2) (b), 3 (b) or (4) (b) as if it were an application for a licence.

(7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.

(8) If, at any time, the Secretary becomes aware that he or she has not been informed of an event referred to in paragraph (1) (b), (2) (b), (3) (b) or (4) (b) in accordance with this regulation, the Secretary may cancel the licence to which the event relates.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 5 CHAPTER
5-EXAMINATION, TESTING AND ANALYSIS OF GOODS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 23
Interpretation

23. In this Chapter, unless the contrary intention appears:
"authorised officer", in relation to a provision in this Chapter, means:
(a) an officer of the Department, of another Department or of an
authority of the Commonwealth; or
(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; Territory;
that is a Department, unit or authority the functions of which relate to health matters;
who is authorised in writing by the Secretary to exercise powers under that provision;
"relevant test", in relation to the analysis of therapeutic goods, means a test that, under regulation 28, is a relevant test for the purposes of determining whether goods of a class in which the first-mentioned goods are included are goods of a particular standard.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 24
Authorised officer-powers and duties

24. (1) An authorised officer may, during normal business hours:
(a) enter the premises of a licence holder on which therapeutic goods are kept for supply; and
(b) inspect the place at which those goods are kept; and
(c) take samples of those goods; and
(d) request the owner of therapeutic goods, or the person apparently in charge of those goods, for information relevant to the manufacture and testing of those goods.

(2) If the registration or listing of goods is subject to the condition that the sponsor of the goods comply with this regulation, the powers of an authorised officer referred to in subregulation (1) extend to the sponsor as if the sponsor were a licence holder.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 25
Appointment of official analysts

25. (1) The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an official analyst for the purposes of these Regulations.

(2) The Secretary is to maintain a register of the names of official analysts and is to cause those names to be published in the Gazette from time to time.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 26
Taking of samples for testing

26. (1) Where an authorised officer takes a sample of therapeutic goods, the authorised officer:
(a) must notify the person from whom the sample was taken that the authorised officer is going to send the sample to an official analyst for analysis; and
(b) must give the person from whom the sample was taken a notice setting out details of the goods taken and, if the person from whom the sample was taken was not the sponsor of the goods, send a copy of that notice to the sponsor of the goods; and
(c) must forward the whole or part of the sample to an official analyst.
(2) The authorised officer must ensure the sample is appropriately packaged, fastened and sealed and is to cause the sample to be stored and transported in accordance with the conditions (if any) specified on the label of the goods.

(3) For the purposes of subregulation (2), a sample is to be fastened and sealed:
(a) in a vessel or package that is marked with the name and address
of the person from whom the sample was taken; and
(b) so as to prevent the opening of the vessel or package, or the
removal of the name and address, without breaking the seal.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 27
Examination and testing by official analyst

27. An official analyst must, as soon as practicable after receiving a sample of goods determine whether the sample is or has been appropriately packaged, fastened and sealed in accordance with subregulation 26 (3) and, if so:
(a) arrange for and supervise the analysis of the sample by means of relevant tests to the extent that the analyst considers necessary to establish:
(i) the quantity and quality of the goods comprising the sample; and
(ii) any other matter relevant to determining whether the goods from
which the sample was taken comply with any standard applicable to them or with conditions relating to matters referred to in paragraph 28 (2) (d) of the Act; and
(b) arrange for the examination of the goods, the label (if any) relating to the goods and the packaging of the goods to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 28
Relevant tests

28. Each of the following is a relevant test for determining whether particular therapeutic goods are of a particular standard:
(a) a test specified by the Minister in an order under section 10 of the Act for those goods in relation to that standard; and
(b) a test specified in a monograph in the British Pharmacopoeia in relation to that standard if:
(i) those goods are for use in humans; and
(ii) the Minister has not specified a test in an order under
section 10 of the Act for those goods in relation to that standard; and
(c) a test specified in a monograph in the British Pharmacopoeia (Veterinary) in relation to that standard if:
(i) those goods are for veterinary use; and
(ii) the Minister has not specified a test in an order
under section 10 of the Act for those goods in relation to that standard; and
(d) a test accepted for the purposes of registration of the goods under Part 3 of the Act; and
(e) any other suitable test that the Secretary requires to be carried out in respect of those goods in relation to that standard.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 29
Certificate of official analyst

29. (1) An official analyst who has arranged and supervised the analysis of a sample of goods must send to the sponsor of the goods, a certificate signed by the official analyst setting out the results of the examination and analysis.

(2) The official analyst must forward a copy of the certificate signed by the official analyst to:
(a) the Secretary; and
(b) the person from whom the sample was taken if that person was not
the sponsor of the goods.

(3) The certificate and copies of the certificate of the official analyst must be sent to the persons referred to in subregulations (1) and (2) within a reasonable time of the completion of the analysis.

(4) In proceedings under the Act or these Regulations, a certificate of an official analyst issued under subregulation (1), or a copy of that certificate, is, in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.

(5) A document purporting to be:
(a) a certificate of an official analyst issued under subregulation
(1); or
(b) a copy of that certificate;
and purporting to be signed by an official analyst is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate and to have been issued under subregulation (1) or (2), as the case requires.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 30
Review of findings of official analyst

30. (1) Where:
(a) an official analyst has issued a certificate under subregulation 29 (1) stating that goods do not conform to a specified standard, or requirement, that is applicable to the goods within the meaning of regulation 27; and
(b) a person to whom the certificate, or a copy of the certificate, was issued, sends to the Secretary evidence in writing establishing that the goods do conform to that standard or requirement;
the person may ask for the results of the analysis to be reviewed.

(2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the certificate, or the copy of the certificate, as the case may be.

(3) The Secretary must extend the period of 21 days if it is not reasonable to expect the person to provide the evidence within the period referred to in subregulation (2).

(4) A person is not to be regarded as having sent the Secretary evidence establishing that goods conform to a particular standard unless that person has sent to the Secretary a certificate of an analyst who has appropriate qualifications and experience setting out:
(a) a statement that the analyst has analysed a part of the same
sample, or a similar sample from the same batch (if any), of those goods; and
(b) the results of that analysis; and
(c) details of the tests used in the analysis.

(5) If the certificate referred to in subregulation (4) shows that an analysis of goods for the purpose of establishing that the goods conform to the standard was carried out in accordance with the relevant tests in relation to the goods, subregulation (6) applies to those goods.

(6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary, at the request of the sponsor of the goods, must direct:
(a) if part of the sample remains unimpaired-the official analyst to
send so much of the sample as remains unimpaired; or
(b) if no part of the sample remains unimpaired-that a further
sample be taken by an authorised person from the same batch as the original sample and that that further sample be sent;
to an analyst agreed upon by the person who requested the review and the official analyst, or, in the absence of agreement, to an analyst nominated by the Secretary.

(7) If a sample is forwarded to an analyst referred to in subregulation (6), the analyst is to:
(a) analyse the sample of the goods in accordance with any relevant
tests;
(b) send to the Secretary a certificate, signed by the analyst,
setting out the results of the analysis; and
(c) send a copy of that certificate, signed by the analyst to the
sponsor of the goods.

(8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7).

(9) If the findings of the official analyst are upheld, the sponsor must pay any charges payable to the analyst referred to in subregulation (6) in respect of the analysis of the sample.

(10) In proceedings under the Act or these Regulations, a certificate of an analyst issued under subregulation (7) or a copy of that certificate is, in the absence of evidence to the contrary, conclusive proof of the matters stated in it.

(11) A document purporting to be:
(a) a certificate of an analyst issued under subregulation (7); or
(b)a copy of that certificate, and purporting to be signed by the
analyst is, in the absence of evidence to the contrary, to be regarded as the certificate, or a copy of the certificate, and to have been issued under that subregulation.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 31
Payment for samples

31. (1) If a sample of therapeutic goods is taken by an authorised officer, the Commonwealth is liable to pay the owner of the goods from which the sample was taken an amount equal to the value of any part of the sample removed by the authorised officer.

(2) The amount the Commonwealth is liable to pay is to be worked out on the basis of the market value of the sample when the sample was taken.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 32
Offences relating to analysis etc.

32. (1) A person must not:
(a) molest, obstruct or try to intimidate or influence an authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or
(b) on being asked by an authorised officer, refuse or fail, without reasonable excuse:
(i) to show the authorised officer the place where any
therapeutic goods are kept; or
(ii) to admit the authorised officer to a place where therapeutic
goods are kept; or
(iii) to show the authorised officer, or let the authorised
officer inspect, therapeutic goods kept by the person; or
(iv) to allow a sample of therapeutic goods to be taken in
accordance with these Regulations; or
(v) to give an authorised officer information required by the
authorised officer, being information relevant to the manufacture and testing of therapeutic goods that the person is able to provide; or
(vi) to assist the authorised officer in the execution of his or
her powers or the performance of his or her duties under these Regulations; or
(c) on being asked by the official analyst, refuse or fail, without reasonable excuse, to give any information required by the official analyst, being information relevant to the testing of therapeutic goods, that that person is able to provide.
Penalty: $1,000.

(2) It is a reasonable excuse for a person to refuse or fail to comply with a request for information under paragraph (1) (b) or (c) if compliance with that request would tend to incriminate that person.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 33
Identity cards

33. (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.

(2) Where the authorised officer enters premises in the course of his or her duties under this Chapter, the authorised officer must, if requested to do so by any person at those premises, produce his or her identity card for inspection by that person.

(3) When a person ceases to be an authorised officer, 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 subregulation: $100.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 6 CHAPTER 6-COMMITTEES

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 34
Therapeutic Goods Committee

34. (1) The Therapeutic Goods Committee is established.

(2) The functions of the Committee are:
(a) to consider any matters referred to it by the Minister relating
to the administration of the Act; and
(b) to consider and inquire into:
(i) the standards applicable to any therapeutic goods and any
matter relating to those standards; and
(ii) the requirements with respect to labelling and packaging of
goods; and
(iii) principles to be observed in the manufacture of therapeutic
goods for use in humans;
and to advise the Minister about those matters, standards, requirements and principles.

(3) The Committee consists of not fewer than 8 persons and not more than 11 persons, each of whom is to be appointed in writing by the Minister.

(4) The Committee is to consist of:
(a) persons, each of whom has expertise in one or more of the
following fields:

(i) pharmaceutics;
(ii) pharmaceutical chemistry;
(iii) pharmacology;
(iv) microbiology;
(v) virology
(vi) therapeutic devices;
(vii) veterinary science
(viii) pharmacognosy; and
(b) at least one person who has experience of each of the following
kinds:

(i) scientific experience in the manufacture of drugs;
(ii) scientific experience in the manufacture of therapeutic
devices;
(iii) consumer affairs experience in respect of therapeutic goods;
and
(c) a person nominated by the Secretary to the Department of Primary
Industries and Energy.

(5) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.

(6) The Committee may appoint sub-committees, consisting of members of the Committee and other persons to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 35
Therapeutic Device Evaluation Committee

35. (1) The Therapeutic Device Evaluation Committee is established.

(2) The functions of the Committee are:
(a) to make
medical and scientific evaluations of therapeutic devices that the Minister or the Secretary refers to it for evaluation; and
(b) to make medical and scientific evaluations of other therapeutic
devices if, in the opinion of the Committee, it is desirable that it should do so; and
(c) to make medical and scientific evaluations of drugs that the
Minister or the Secretary refers to it for evaluation; and
(d) to give such advice to the Minister or the Secretary about the
importation into, the exportation from and the production and distribution within, Australia of therapeutic goods that have been the subject of evaluation by the Committee; and
(e) to give advice that has been given to the Minister
or the Secretary under paragraph (d) to such persons or bodies as the Minister directs.

(3) The Committee consists of not less than 6 and not more than 9 persons appointed in writing by the Minister from persons at least 6 of whom are expert in one or more of the following disciplines:
(i) anaesthetics;
(ii) bioengineering;
(iii) biomaterials;
(iv) dentistry;
(v) epidemiology;
(vi) intensive care
(vii) medicine;
(viii) microbiology;
(ix) ophthalmology;
(x) pharmaceutics;
(xi) surgery;
(xii)nursing.

(4) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.

(5) The Committee may appoint sub-committees, consisting of members of the Committee and other persons, to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 36
Australian Drug Evaluation Committee

36. (1) The Australian Drug Evaluation Committee is established.

(2) The functions of the Committee are:
(a) to make medical and scientific evaluations of any drugs that the
Minister or the Secretary refers to it for evaluation; and
(b) to make medical and scientific evaluations of other drugs if, in
the opinion of the Committee, it is desirable that it should do so; and
(c) to make medical and scientific evaluations of such therapeutic
devices that the Minister or the Secretary refers to it for evaluation; and
(d) to give advice to the Minister or the Secretary about the
importation into, the exportation from and the production and distribution within, Australia of therapeutic goods that have been the subject of evaluation by the Committee; and
(e) to give advice that has been given to the Minister or the
Secretary under paragraph (d) to persons or bodies as the Minister may direct.

(3) The Committee consists of not less than 6 and not more than 9 members, who are to be appointed, in writing, by the Minister.

(4) In appointing members of the Committee, the Minister is to ensure that the members include:
(a) not less than 4 persons each of whom is a medical practitioner
eminent in his or her profession and of whom at least 3 are specialists in clinical medicine; and
(b) not less than 2 persons, each of whom is a pharmacologist or a
person who has been admitted to a degree in science or a branch of science by a university and has specialised in pharmaceutical science.

(5) The Minister is to appoint, in writing, a member of the Committee to be its chairperson.

(6) The Committee may appoint sub-committees, consisting of members of the Committee and other persons, to inquire into, and report to the Committee on, any matter that is within the functions of the Committee.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 37
Minister or Secretary may seek further advice

37. Where a Committee established under this Chapter gives advice to the Minister or the Secretary, the Minister or the Secretary may send a copy of that advice to another Committee established under this Chapter and that other Committee may make comments to the Minister or the Secretary in relation to that advice as it thinks fit.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 38
Tenure of office of members

38. A member of a Committee established under this Chapter holds office for not more than 3 years unless the member is removed from office before the end of that period.

(2) A member is eligible for re-appointment.

(3) The Minister may, by instrument, remove a member from office at any time.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 39
Disclosure of Interests

39. (1) A member of a Committee established under this Chapter who has a direct or indirect pecuniary interest in a matter being considered or about to be considered at a meeting of the Committee must, as soon as possible after the relevant facts have come to the member's knowledge, disclose the nature of the interest at a meeting of the Committee.

(2) The disclosure is to be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines:
(a) be present during any deliberation of the Committee with respect
to the matter; or
(b) take part in any decision of the Committee with respect to
that matter.

(3) For the purpose of the making of a determination in relation to the member who has made the disclosure, any member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates must not:
(a) be present during any deliberation of the Committee for the
purpose of making the determination; or
(b) take part in the making of the determination by the Committee.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 40
Acting Members

40. (1) The chairperson may appoint a person to act as a member:
(a) during a vacancy in the office, whether or not an appointment has previously been made to the office; or
(b) during any period, or during all periods, when the holder of the office is absent from duty or from Australia or is, for any other reason, unable to perform the duties of the office.

(2) A person appointed to act during a vacancy in the office of a member must not continue so to act for more than 12 months.

(3) Anything done by a person purporting to act as a member is not invalid merely because:
(a) the occasion for the appointment had not arisen; or
(b) there is a defect or irregularity in connection with the
person's appointment; or
(c) the appointment had ceased to have effect; or
(d) the occasion for the person to act had not arisen or had ceased.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 41
Meetings of Committees

41. (1) Meetings of a Committee established under this Chapter are to be held the times and places that the chairperson of the Committee directs.

(2) At a meeting of a Committee:
(a) in the case of the Therapeutic Goods Committee-5 members
constitute a quorum; and
(b) in the case of the Australian Drug Evaluation
Committee:
(i) if fewer than 7 members of the Committee are in Australia
when a meeting is held-3 members constitute a quorum; or
(ii) in any other case-4 members constitute a quorum; and
(c) in the case of the Therapeutic Device Evaluation Committee-4
members constitute a quorum.

(3) The chairperson of a Committee is to preside at all meetings of the Committee at which he or she is present.

(4) If the chairperson of a Committee is absent from a meeting of a Committee, the members of the Committee present are to appoint one of their number to preside at that meeting.

(5) A question arising at a meeting of a Committee is to be determined by a majority of votes of the members present and voting.

(6) The member presiding at a meeting of a Committee has a deliberative vote and, in the event of an equality of votes, also has a casting vote.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 42
Effect of vacancy on Committee

42. The exercise of a power or the performance of a function of a Committee established under this Chapter is not affected by a vacancy or vacancies in the membership of that Committee.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 7 CHAPTER 7-FEES AND
COSTS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 43
Fees

43. (1) The fees specified in column 3 of an item in Schedule 8 are prescribed in respect of the matters specified in column 2 of that item.

(2) If, but for this subregulation, more than one fee referred to in item 9 of Schedule 8 would otherwise apply in relation to:
(a) an application to carry out steps in the manufacture of
therapeutic goods at particular premises; or
(b) the inspection of licensed manufacturing premises for the
purposes of section 40 of the Act
the fee that is the greatest applicable fee is the only fee that applies in respect of that application or inspection.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 44
Testing of samples-recovery of costs

44. If a person asks the Department to analyse a sample of goods, the costs incurred by the Department in carrying out that analysis are recoverable from that person as a debt due to the Commonwealth.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 45
Waiver or reduction of fees

45. (1) The Secretary may waive or reduce any fees specified in Schedule 8 payable in relation to the supply of therapeutic goods if the supply of those therapeutic goods, in the opinion of the Secretary:
(a) is in the interest of public health; and
(b) would not be commercially viable for the sponsor of the goods if the fee were paid.

(2) The Secretary may waive or reduce any fees specified in Schedule 8 payable in relation to therapeutic goods if a person submits more than one application for registration of the goods at the same time and:
(a) the goods in each application contain the same therapeutically
active ingredient; and
(b) in the opinion of the Secretary, the information in support of
each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - CHAPTER 8 CHAPTER 8-MISCELLANEOUS

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 46
Release of information

46. (1) In this regulation, "therapeutic goods information" has the same meaning as in section 61 of the Act.
(2) For the purposes of subsection 61 (6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information relating to:
(a) whether the goods are included in the Register, and, where
included, the registration or listing number of the goods and the class in which the goods are included;
(b) the name of the goods and the name and address of the sponsor of
the goods;
(c) if any ingredient in, or component of, the goods
is derived from an animal, the species of the animal;
(d) if the goods are supplied in a sterile state, the technique of
sterilisation used;
(e) if the goods are drugs:

(i) the quantity of goods in the primary pack; and
(ii) the entry relating to the drugs in the Poisons Schedule; and
(iii) the indications for the drugs; and
(iv) the dosage form of the drugs and their physical appearance;
and
(v) the names and quantities of therapeutically active substances
in the drugs; and
(vi) the presence or absence of any specific excipient in the
drugs; and
(vii) the routes of administration of the drugs;
(f) if the goods are therapeutic devices, a description of the
devices, including the name and code (if any) by which the devices are classified.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 47
Delegation

47. The Secretary may, by signed instrument, delegate to an officer of the Department all or any of the Secretary's powers and functions under these Regulations other than the power of delegation.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - REG 48
Review of decisions

48. (1) In this regulation:
"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975;
"initial decision" means a decision of the Secretary under regulation 7 or 9 or subregulation 13 (7) or 22 (8);
"reviewable decision" means a decision of the Minister under subsection (3) of the Act.

(2) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice.

(3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and 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) If a person who has made a request under subregulation (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) If 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 regulation;
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 subregulation (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.

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 1

SCH

SCHEDULE 1 Regulation 8
PROHIBITED AND REQUIRED REPRESENTATIONS FOR THE PURPOSES
OF PARAGRAPHS 6 (a) AND (b)
PART 1
PROHIBITED REPRESENTATIONS
Column 1 Column 2 Column 3
Item No. Representation Therapeutic
Goods
1 a representation in respect of the use of
goods in relation to: all therapeutic
goods
abortifacient action
alcoholism
anaemia
arthritis (all forms, including rheumatoid
arthritis), other than temporary relief of
pain
asthma
baldness, including hair growth or hair loss
blindness
boils, other than treatment by topical
application
bronchitis, other than relief of cough
bust development
carbuncles, other than treatment by topical
application
cardio-vascular system diseases, ailments or
defects (including high or low blood
pressure) other than:
(a) the advertising of blood pressure
appliances where the advertisement includes a
statement to the effect that a medical
practitioner is the only person qualified to
evaluate the meanings of recorded blood
pressure; and
(b) the advertising of cholesterol
measurement services or appliances where that
advertising includes a statement to the effect
that a medical practitioner is the only
qualified person to evaluate the meanings of
recorded cholesterol levels
cataract
catarrh, other than temporary relief
chilblains, other than temporary relief of
symptoms
colds, other than temporary relief
coughs, other than temporary relief
croup
deafness, other than relief by an appliance
diphtheria
eczema, other then temporary relief of
symptoms
endocrine system diseases, ailments, defects
or injuries (including diabetes and goitre),
other than the advertising of blood glucose
monitoring products
erysipelas
fertility
fungus infections including tinea (athlete's
foot), other than for relief or treatment by
topical application
gallbladder diseases, ailments, defects or
injuries
gastric, peptic or duodenal ulcer
genito-urinary system diseases, ailments,
defects or injuries
glandular diseases, ailments, defects or
injuries (including glandular enlargement)
glaucoma
gout
haemorrhoids, other than:
(a) temporary relief of discomfort by local
application and where the directions for use
include the statement that sufferers should
consult a doctor if the symptoms persist; or
(b) reference to bulk-producing laxatives
being of indirect benefit to people suffering
from haemorrhoids
headaches, other than temporary relief
height increase
hernia or rupture, other than advertising of
hernia appliances
herpes virus infections other than:
(a) the relief of the symptoms of cold
sores; or
(b) the reduction of risk of the
transmission of genital herpes by the use of
condoms
hormonal diseases, ailments, defects or
injuries
immune system diseases, ailments, defects or
injuries, including acquired immune deficiency
syndrome (A.I.D.S.), other than reduction of
the risk transmission of disease by the use of
condoms
impetigo, other than treatment by topical
application
impotence
indigestion, other than temporary relief
infertility
influenza, other than temporary relief of
symptoms
liver diseases, ailments, defects or injuries
lupus
menopausal diseases, ailments, defects or
conditions
menstrual cycle diseases, ailments, defects or
injuries, other than the temporary relief of
menstrual pain and pre-menstrual symptoms
where the advertisement includes the following
statement:
"Use only as directed and consult your
doctor if pain or symptoms persist"
mental diseases, disorders or illness
mouth ulcers, other than temporary relief
muscular aches and pains, other than temporary
relief
neoplastic diseases (including cancer and
leukemia), other than the use of sun-screening
preparations as an aid in the prevention of
skin cancer, but without implying that long
hours of exposure in the sun are desirable
nervous system diseases, ailments, defects or
injuries (including convulsions, epilepsy,
fits, or paralysis)
obesity including the reduction of
subcutaneous fat also referred to as
"cellulite"
overweight, other than suppression of appetite
in conjunction with a balanced low joule
(calorie) diet
phlebitis
prostate gland disease, ailments, defects or
injuries
psoriasis except for the relief or treatment
of the effect of psoriasis on the skin:
(a) where the advertisement carries the
warning:
"do not use for prolonged periods
without consulting a medical practitioner";
and
(b) if the advertisement is an
advertisement for products that contain coal
tar-where the advertisement carries the
additional warning:
"do not use this product with other
forms of psoriasis therapy such as ultraviolet
radiation or prescription drugs unless
directed to do so by a medical practitioner"
psychiatric disease, disorders or illness
purpura
pyorrhoea
rheumatism, other than temporary relief of
pain
scabies, other than relief by topical
application
sexual intercourse and diseases arising from
sexual intercourse other than:
(a) reduction in the possibility of
conception; or
(b) reduction of the risk of transmission
of sexually transmissible diseases by the use
of condoms
sexual function, potency or virility
short stature
sinus infection, other than temporary relief
of sinusitis
sleeplessness, other than temporary relief
thrombosis
tuberculosis
varicose ulcers or varicose veins other than
the temporary relief by the use of elastic
hosiery
whooping cough
2 a representation with respect to the use of
goods that: all therapeutic
goods
(a) depicts excessive pain or suffering; or
(b) induces or is likely to induce persons
to believe that they are suffering from a
serious ailment; or
(c) induces or is likely to induce persons
to believe that harmful consequences will
result if those goods are not used or
consumed, except where the representation is
approved in writing by the Secretary; or
(d) disparages any physical or mental
affliction or disformity; or
(e) makes any reference to a dose of a drug
in excess of a therapeutic dose; or
(f) claims or implies that those goods are
recommended or used generally by medical
practitioners, pharmacists, dentists, nurses
or physiotherapists or by persons having or
purporting to have a qualification in a health
care field; or
(g) states that the goods are safe or that
their use cannot cause harm, except where the
representation is approved in writing by the
Secretary
3 a representation with respect to the use of
goods in which it is stated or implied that
those goods: all therapeutic
goods
(a) are a universal panacea; or
(b) possess infallible, unfailing, sure,
magical or miraculous curing properties; or
(c) possess unique or absolute properties
except where the Secretary, after considering
all the circumstances, considers that the
representation is substantiated; or
(d) are immediately or rapidly acting
except where the Secretary, after considering
all the circumstances, considers that the
representation is substantiated; or

(e) are a natural remedy or nature's
remedy; or
(f) possess stimulant properties; or
(g) promote vitality; or
(h) must be used for the relief of symptoms
of a disease, ailment, defect or injury; or
(i) are, or contain, a vitamin-unless those
goods are composed of, or contain, a substance
specified in column 2 of an item in Part 3 or
a salt or derivative of a substance and that
substance is described either by the name
referred to in column 2 of that item, or by
the name of its salt or derivative, or by the
name specified in column 3 of that item and
not otherwise; or
(j) are, or contain, a substance described
as a vitamin otherwise than by a description
specified in Column 2 or 3 of Part 3; or
(k) will effect rejuvenation, regeneration
or revitalisation of the human body or any
part of it or, except for broad-spectrum
sunscreen preparations, in any way arrest or
reverse the ageing process
4 a representation that: analgesics
(a) analgesic consumption is safe; or
(b) analgesic preparations will relieve
tension, relax, sedate or stimulate; or
(c) an analgesic is appreciably less
irritating to the stomach, more rapidly
absorbed or less harmful than any other
analgesic except where the representation is
approved in writing by the Secretary
5 a representation containing a reference to
bacteriostatic activity, except where it is
made in conjunction with a reference to
bactericidal activity disinfectants
6 a representation:
(a) containing reference to the
Rideal-Walker test or to the Phenol
Coefficient; or disinfectants and
antiseptics
(b) on any label, containing a reference to
the results of laboratory tests on
micro-organisms; or
(c) containing a reference to the
achievement of sterility except where the
representation is approved in writing by the
Secretary
7 a representation that antiseptics promote
healing liquid antiseptics
8 a representation that:
(a) the use of vitamin supplements can be
justified by claims that soil depletion
reduces nutritional values of food or that
processed foods lack nutritional value; or vitamins
(b) differentiates between the respective
values of natural and synthetic vitamins; or
(c) vitamins are of benefit in cases of
irritability, nervousness, stress or sexual
inadequacy; or
(d) vitamins stimulate the appetite or
growth; or
(e) vitamins occasion good looks, good
health or long life; or
(f) vitamins provide nutritional insurance
9 a representation that: vitamins and
(a) purports to show the recommended daily
or dietary intake or allowance of a vitamin or
a mineral unless the amount shown is that
recommended by the National Health and Medical
Research Council; or minerals
(b) expresses the quantity of a vitamin or
a mineral contained in a preparation as a
percentage or proportion of the recommended
daily or dietary intake or allowance
PART 2
REQUIRED REPRESENTATIONS
Column 1
Item No. Column 2
Representation Column 3
Therapeutic Goods
1 a statement that vitamins can only be of
assistance if the dietary vitamin intake is
inadequate vitamin
preparations
supplied in
Australia
PART 3
VITAMINS REFERRED TO IN ITEM 3 OF PART 1
Column 1
Item No. Column 2
Substance Column 3
Name
1 Vitamin A -
2 Thiamine Vitamin B1
3 Riboflavine Vitamin B2
4 Nicotinic Acid Vitamin B3
5 Pantothenic Acid Vitamin B5
6 Pyridoxine Vitamin B6
7 Cyanocobalamin Vitamin B12
8 Ascorbic Acid Vitamin C
9 Ergocalciferol Vitamin D2
10 Cholecalciferol Vitamin D3
11 alpha-Tocopherol Vitamin E
12 Biotin Vitamin H
13 Phytomenadione Vitamin K1
14 Menaphthone Vitamin K3
15 Folic Acid

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 2

SCH

SCHEDULE 2 Regulation 10
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN
THE PART OF THE REGISTER FOR REGISTERED GOODS
Item No. Therapeutic goods
1 drugs referred to in item 1 in Schedule 3
2 drugs, other than drugs:
(a) referred to in items 3 to 10
(inclusive) in Schedule 3 unless:
(i) the intended action or purpose of
the drugs is in the treatment of a condition
referred to in item 1 of Part 1 of Schedule 1;
or
(ii) the drugs are supplied as
pharmaceutical benefits; or
(b) referred to in item 1, 2, 3, 4, 5, 6, 8
or 9 in Schedule 4 unless those drugs are
supplied as pharmaceutical benefits
3 therapeutic devices that are:
(a) implantable intra-ocular lenses; or
(b) intra-uterine contraceptive devices; or
(c) implantable cardiac pacemakers and
their accessories; or
(d) implantable defibrillators and their
accessories; or
(e) implantable cardioverters and their
accessories; or
(f) prosthetic heart valves; or
(g) intra-ocular visco-elastic fluids; or
(h) powered drug infusion systems which
regulate the flow of infusate; or
(i) devices of human or animal origin for
use on or in the body of a person

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 3

SCH

SCHEDULE 3 Regulation 11
THERAPEUTIC GOODS REQUIRED TO BE INCLUDED IN THE PART OF
THE REGISTER FOR LISTED GOODS
PART 1
LISTABLE THERAPEUTIC GOODS
Item No. Therapeutic goods
1 therapeutic goods manufactured in Australia
for export only other than goods exempt under
regulation 12
2 therapeutic devices other than devices to
which:
(a) item 3 of Schedule 2 applies; or
(b) item 1, 2, 3, 4, 5, 6 or 7 of Schedule
4 applies
3 preparations containing as their
therapeutically active ingredients only
vitamins, minerals or herbal substances and
other substances specified in Part 5 or
combination of those substances where:
(a) the preparation is not included in a
Schedule to the Poisons Standard or is not of
a kind required to be sterile; and
(b) the vitamins consist only of vitamins
or their salts specified in Part 2; and
(c) the minerals consist only of minerals
or their salts specified in Part 3; and
(d) the herbal substances are not derived
from herbs specified in Part 4
unless the intended action or purpose of the
preparation is in the treatment of a condition
referred to in item 1 of Part 1 of Schedule 1
4 mother tinctures:
(a) not included in a Schedule to the
Poisons Standard; and
(b) where the intended action or purpose of
the mother tincture is not in the treatment of
a condition referred to in item 1 of Part 1 of
Schedule 1
5 dilutions of mother tinctures in water,
ethanol, aqueous ethanol or lactose for use as
homoeopathic preparations:
(a) where each dilution:
(i) does not exceed a one thousand fold
dilution; and
(ii) is not required to be sterile; and
(iii) is not included in a Schedule to
the Poisons Standard; and
(b) where the intended action or purpose of
the dilution is not in the treatment of a
condition referred to in item 1 of Part 1 of
Schedule 1

6 medicated throat lozenges where the medication
consists only of volatile oils and their
constituents alone or in combination with
acsorbic acid or its salts and unless the
intended action or purpose of the lozenges is
in the treatment of a condition referred to in
item 1 of Part 1 of Schedule 1
7 sunscreen preparations for dermal use that,
when tested as described in Australian
Standard AS2604-1986 as amended and in force
from time to time, are established to have,
and claim on their labels, a sun protection
factor of 4 or greater (or the equivalent
category description) unless the intended
action or purpose of the preparation is in the
treatment of a condition referred to in item 1
of Part 1 of Schedule 1
8 uncompounded drug substances packed for retail
sale:
(a) being substances that comply with a
monograph of the British Pharmacopoeia for
those substances and that are not included in
a Schedule to the Poisons Standard; and
(b) where the intended action or purpose of
the substances is not in the treatment of a
condition referred to in item 1 of Part 1 of
Schedule 1
9 pressurised aerosol, medicated space sprays
where the medication consists only of volatile
oils and their constituents
10 drugs containing amino acids for therapeutic
use singly or in combination with other
substances unless:
(a) the amino acids are tryptophan,
arginine, ornithine, phenylalanine,
methionine, tyrosine, lysine, carnitine,
taurine, aspartic acid or glutamic acid; or
(b) the other substances are included in
Schedule 2; or
(c) the goods are included in a Schedule to
the Poisons Standard; or
(d) the goods are in a form required to be
sterile; or
(e) the intended action or purpose of the
goods is in the treatment of a condition
referred to in item 1 of Part 1 of Schedule 1
PART 2
VITAMINS AND THEIR SALTS TO WHICH PARAGRAPH (b) OF
ITEM 3 OF PART 1 APPLIES
Approved Name Synonym
Acetomenaphtone
Ascorbic acid Vitamin C
Betacarotene
Biotin Vitamin H
Calcium ascorbate
Calcium folinate
Calcium pantothenate
Cholecalciferol Vitamin D3
Cyanocobalamin Vitamin B12
Ergocalciferol Vitamin D2
Folic acid
Hydroxocobalamin Vitamin B12
Magnesium ascorbate
Nicotinamide
Nicotinic acid
Panthenol
Pantothenic acid Vitamin B5
Phytomenadione Vitamin K1
Potassium ascorbate
Pyridoxine hydrochloride
Vitamin B6
Retinyl acetate Vitamin A acetate
Retinyl palmitate Vitamin A palmitate
Riboflavine Vitamin B2
Riboflavine sodium
phosphate
Sodium ascorbate
Sodium pantothenate
Thiamine hydrochloride Vitamin B1
Thiamine nitrate
d-alpha-Tocopherol Vitamin E
dl-alpha-Tocopherol
d-alpha-Tocopheryl
acetate
dl-alpha-Tocopheryl
acetate
d-alpha-Tocopheryl acid
succinate
dl-alpha-Tocopheryl acid
succinate
Vitamin A Retinol
PART 3
MINERALS AND THEIR SALTS TO WHICH PARAGRAPH (c) OF ITEM 3 OF PART 1 APPLIES
Name
Ammonium iron (III) citrate
Calcium amino acid chelate as a source of calcium
Calcium carbonate
Calcium citrate
Calcium gluconate
Calcium glycerophosphate
Calcium hydrogen phosphate
Calcium lactate
Calcium orotate
Calcium phosphate
Calcium sodium lactate
Calcium sulfate
Chromium (III) chloride
Copper gluconate
Copper (II) oxide
Copper (II) sulfate
Ferric chloride
Ferric glycerophosphate
Ferric pyrophosphate
Ferrous carbonate
Ferrous chloride
Ferrous fumarate
Ferrous gluconate
Ferrous phosphate
Ferrous succinate
Ferrous sulfate
Iron amino acid chelate as a source of iron
Iron (III) chloride
Magnesium amino acid chelate as a source of magnesium
Magnesium carbonate
Magnesium chloride
Magnesium citrate
Magnesium gluconate
Magnesium glycerophosphate
Magnesium orotate
Magnesium oxide
Magnesium phosphate
Magnesium sulfate
Manganese (IV) oxide
Manganese glycerophosphate
Manganese sulfate
Potassium iodide
Sodium chloride
Sodium phosphate
Zinc amino acid chelate as a source of zinc
Zinc chloride
Zinc citrate
Zinc gluconate
Zinc oxide
Zinc succinate
Zinc sulfate
PART 4
HERBS TO WHICH PARAGRAPH (d) OF ITEM 3 OF PART 1 APPLIES
Name Common Name
Abrus precatorius Jequirity
Acorus calamus Sweet flag, Blue flag
Argyreia nervosa Morning glory
Aristolochia species Snakeroot, Birthwort
Amanita muscaria & spp.
Anadenanthera peregrina
Banisteriopsis caapi Banisteria
Brachyglottis species
Cannabis
Catha edulis Khat
Conocybe siligineoides and species
Crotolaria species
Cynoglossum officinale Hounds tongue
Echium vulgare Bugloss
Erythroxylum coca Coca leaf
Gymnopilus species
Haemadictyon species
Heliotropium species Heliotrope
Ipomoea burmanni
Ipomoea hederacea
Ipomoea tricolor
Ipomoea violacea
Lithospermum species
Lophophora species
Opuntia cylindrica San Pedro cactus
Papaver somniferum Opium poppy
Papaver bracteatum
Peganum harmala Wild rue
Petasites species Butterbur
Phytolacca americana (decandra) Pokewee
Piptadenia macrocarpa
Piptadenia peregrina Cohoba
Psylocybe species
Pteridium aquilinum Bracken Fern
Rivea corymbosa
Sassafras albidum Sassafras
Senecio species Liferoot
Solanum dulcamara Bittersweet
Sophora secundiflora Mescal bean
Stropharia cubensis
Strychnos ignatii Ignatious bean
Strychnos gautheriana
Symphytum species Comfrey
Tussilago farfara Coltsfoot
PART 5
SUBSTANCES TO WHICH ITEM 3 OF PART 1 APPLIES
Name
Chlorophyll
Dolomite
Fructose
Glucose
Lecithin
Methylcellulose
Oyster shell
Pectin

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 4

SCH

SCHEDULE 4 Regulation 12
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF
PART 3 OF THE ACT
Column 1 Column 2
Item No. Therapeutic goods
1 therapeutic goods that are imported for use in
the treatment of the importer or the
importer's immediate family where:
(a) the goods do not contain a substance
the importation of which is prohibited under
the Customs Act 1901; and
(b) in the case of injections-the goods are
the subject of an approval under section 19 of
the Act; and
(c) in the case of other drugs-the quantity
imported represents not more than 3 month's
supply at the maximum dose recommended by the
manufacturer; and
(d) the goods:
(i) are subject to Schedule 4 to the
Poisons Standard; and
(ii) are the subject of a written
authority issued by a medical practitioner
registered under a law of a State or
Territory;
(d) except where the goods are carried by
the importer as a passenger on a ship or
aeroplane
2 therapeutic goods that are exported and that:
(a) are not for commercial supply; and
(b) do not contain a substance the
exportation of which is prohibited under the
Customs Act 1901
3 samples of therapeutic goods supplied for:
(a) submission to a regulatory authority;
or
(b) subjection to developmental or quality
control procedures; or
(c) examination, demonstration or display;
or
(d) subjection to analysis or laboratory
testing procedures;
but not for supply for therapeutic use in
humans
4 goods imported solely for the purpose of
export that remain subject to the control of
the Customs and that are not subject to
manufacture in Australia
5 goods imported into Australia that are held
under the direct control of the sponsor
pending approval for registration or listing
6 therapeutic goods that are manufactured or
dispensed or extemporaneously compounded for a
particular person for therapeutic application
to that person (other than electronic devices
that must be programmed for each patient using
them)
7 the following therapeutic devices and parts of
therapeutic devices:
(a) components and parts of therapeutic
devices intended for use in the manufacture,
installation, repair or maintenance of devices
that are not provided separately to the
consumer as an accessory or consumable
component;
(b) diagnostic goods for in vitro use other
than:
(i) goods that are represented in any
way to be, or that are for any reason, likely
to be taken to be for use by a person not
otherwise trained:
(A) in the use of diagnostic equipment;
or
(B) in the diagnosis or monitoring of a
disease, ailment, defect, injury or condition
in that person; or
(ii) goods that incorporate material of
human origin; or
(iii) goods supplied as a pharmaceutical
benefit; or
(iv) goods for use in the diagnosis of
infection with Human Immunodeficiency Virus;
(c) non implantable, non powered diagnostic
tools and instruments that are not supplied in
a sterile state;
(d) non powered surgical or dental
instruments that are not supplied in a sterile
state, other than flexible tubing catheters,
cannulae, fluid and gas lines and other
instruments that introduce substances to, or
remove substances from, the body;
(e) manufacturing, laboratory and
dispensary equipment used in the preparation
of therapeutic goods other than equipment
specifically designed to process a patient's
blood or other tissues for reintroduction to
that patient;
(f) therapeutic devices for dental use that
are specified in the most recent notice
published in the Australian Dental Journal as
products certified or approved by the
Australian Dental Association's Therapeutics,
Instruments, Materials and Equipment Committee
(other than toothpastes to which a Schedule of
the Poisons Standard applies);
(g) non-powered equipment used in general
patient care being equipment that does not
constitute or contribute to a specific
diagnosis, monitoring or treatment of a
medical condition;
(h) furniture other than powered appliances
for use in diagnosis or treatment of a medical
condition;
(i) linen and bedding other than linen and
bedding supplied in a sterile state;
(j) protective clothing for patients or
health workers other than:
(i) clothing supplied in a sterile
state; or
(ii) surgeon's gloves and patient
examination gloves; or
(iii) patient nuclear radiation
shielding apparel;
(k) communications equipment;
(l) containers other than syringes
8 the following drugs unless their intended
action or purpose is in the treatment of a
condition referred to in item 1 of Part 1 of
Schedule 1:
(a) homoeopathic preparations more dilute
than a one thousand fold dilution of a mother
tincture in water, ethanol, aqueous ethanol or
lactose and which are not required to be
sterile or are not included in a Schedule to
the Poisons Standard;
(b) antiperspirant preparations that derive
their antiperspirant properties from inorganic
salts of aluminium, zinc or zirconium only;
(c) unmedicated anti-acne preparations
having only a cleansing action or purpose;
(d) medicated insect repellants for dermal
use except those that are included in a
Schedule to the Poisons Standard;
(e) lotions, shampoos or hairdressings for
the prevention or treatment of dandruff except
those that are included in a Schedule to the
Poisons Standard;
(f) disinfectants;
(g) sunscreen preparations for dermal use
that when tested as described in Australian
Standard AS2604-1986 as amended from time to
time, are established to have, and claim on
their labels, a sun protection factor below 4
or the equivalent category description
9 the following drugs:
(a) starting materials used in the
manufacture of therapeutic goods, except when:
(i) prepackaged for sale for other
therapeutic purposes; or
(ii) formulated as a dosage form;
(b) blood and blood components manufactured
by the Australian Red Cross Society

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 5

SCH

SCHEDULE 5 Regulation 16
THERAPEUTIC DEVICES PRESCRIBED FOR THE PURPOSES OF
PARAGRAPH 26 (1) (g) OF THE ACT
Column 1 Column 2
Item No. Device
1 therapeutic devices supplied as pharmaceutical
benefits
2 therapeutic devices that are required to be,
or that are represented to be, sterile
3 therapeutic devices that are not sterile and
do not contain or include any sterile
component or portion and that are:
(a) devices for use in contraception or in
the prevention of transmission of disease
between persons; or
(b) materials for the restoration or
replacement of teeth or other matter intended
to be implanted in the human body; or
(c) bandages (excluding casting bandages),
dressings, gauzes and undercast padding; or
(d) soft contact lenses; or
(e) lubricants for insertion into body
cavities or orifices; or
(f) diagnostic goods for in vitro use that
are:
(i) goods that are represented in any
way to be, or that are, for any reason, likely
to be taken to be for use by a person not
otherwise trained:
(A) in the use of diagnostic equipment;
or
(B) in the diagnosis or monitoring of a
disease, ailment, defect, injury or condition
in that person; or
(ii) goods that incorporate material of
human origin; or
(iii) goods for use in the diagnosis of
infection with Human Immuno-deficiency Virus
4 containers (not being glass containers) that
are:
(i) designed to contain blood or blood
components; or
(ii) intended for use with goods for
parenteral administration

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 6

SCH

SCHEDULE 6 Regulation 17
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 4
OF THE ACT UNLESS SUPPLIED AS PHARMACEUTICAL BENEFITS
Column 1 Column 2
Item No. Therapeutic goods
1 goods prepared for the initial experimental
studies in human volunteers
2 ingredients, except water, used in the
manufacture of therapeutic goods where those
ingredients do not have a therapeutic action
3 components for therapeutic devices that are
intended to be inserted into the human body,
except for those components that come into
direct contact with body tissue or body fluids
4 therapeutic devices that are not sterile and
do not contain or include any sterile
component or portion, other than:
(a) devices for use in contraception or
prevention of transmission of disease between
persons; or
(b) materials for restoration or
replacement of teeth or other matters intended
to be implanted in the human body; or
(c) bandages (excluding casting bandages),
dressings, gauzes and undercast padding; or
(d) soft contact lenses; or
(e) lubricants for insertion into body
cavities or orifices; or
(f) any other devices included in Schedule
2; or
(g) diagnostic goods for in vitro use that
are:
(i) goods that are represented in any way
to be, or that are, for any reason, likely to
be taken to be for use by person not otherwise
trained:
(A) in the use of diagnostic equipment;
or
(B) in the diagnosis or monitoring of a
disease, ailment, defect, injury or condition
in that person; or
(ii) goods that incorporate material of
human origin;
(iii) goods for use in the diagnosis of
infection with Human Immunodeficiency Virus
5 containers (other than glass containers) that
are not:
(a) designed to contain blood or blood
components; or
(b) intended for use with goods for
parenteral administration
6 toothpastes
7 homoeopathic preparations more dilute than a
one thousand fold dilution of a mother
tincture in ethanol, aqueous ethanol or
lactose and that are not required to be
sterile
8 antiperspirant preparations that derive their
antiperspirant properties from inorganic salts
of aluminium, zinc or zirconium only
9 unmedicated anti-acne preparations having only
a cleansing action or purpose
10 medicated insect repellents for dermal use
11 lotions, shampoos or hairdressings for the
prevention or treatment of dandruff
12 medicated soaps other than liquid medicated
soaps
13 disinfectants
14 sunscreen preparations for dermal use
15 medicated throat lozenges, where the
medication consists only of volatile oils and
their constituents either alone or in
combination with ascorbic acid or its salts
16 pressurised aerosol, medicated space sprays
where the medication consists only of volatile
oils and their constituents

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 7

SCH

SCHEDULE 7 Regulation 18
PERSONS EXEMPT FROM THE OPERATION OF
PART 4 OF THE ACT
Column 1 Column 2 Column 3
Item No. Persons Matter in relation
to which person exempted
1 medical
practitioners,
dentists and health
care workers
registered under a
law of a State or
Territory the manufacture of:
(a) a drug by a medical practitioner or a
dentist specifically for a patient under his or her care; or
(b) a therapeutic device by a health care
worker specifically for a patient under his or
her care
2 pharmacists the manufacture of therapeutic goods produced
by the pharmacist:
(a) in a pharmacy where the pharmacist
practices and the pharmacy is open to the
public; or
(b) on the premises of a dispensary
conducted by a Friendly Society; or
(c) on the premises of a private hospital;
for supply (other than by wholesale) on or from those premises
3 biomedical
engineers,
radio-chemists
and
pharmacists in
public hospitals the manufacture of therapeutic goods by the
person when employed by a public hospital or a
public institution and produced by that person
for supply in hospitals or public institutions
in the same State or Territory
4 persons engaged
in the
manufacture of any
herbal or
homoeopathic
preparation where the preparation is for use in the course
of his or her business and:
(a) the preparations are manufactured on
premises that the person carrying on the
business occupies and that he or she is able to close so as to exclude the public; and
(b) the person carrying on the business
supplies the preparation for administration to
a particular person after being requested by or on behalf of that particular person and in that particular person's presence to use his or her
own judgment as to the treatment required
5 a person who
applies
supplementary
labelling to a
manufactured
product the application of supplementary labelling,
where the supplementary label contains only a
name and address or the registration or listing number of goods
6 persons who operate
blood collection
centres the operation of human blood collection centres except those that supply plasma for the
manufacture of blood components

1990 No. 88 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 8

SCH

SCHEDULE 8 Regulation 43
FEES
Column 1 Column 2 Column 3 Item Matter Fee ------------------------------------------------------------------------------ -- $ 1 Evaluation fee for the purposes of
subparagraph 19 (2) (b) (iii) of the Act:
(a) if the goods are drugs for use solely
for experimental purposes in humans and the
evaluation is based on a check list of
chemistry and quality control information and
guidelines relating to clinical usage 800 (b) if the goods are drugs for use solely
for experimental purposes in humans (other
than drugs to which paragraph (a) applies)-for
each drug 10,100 (c) if the goods are therapeutic devices
and they are evaluated on the basis that they
are substantially similar to other devices 800 (d) if the goods are therapeutic devices to
which paragraph (c) does not apply 7,000 2 Application fee for the purposes of paragraph
23 (c) of the Act for registration of
therapeutic goods:
(a) if the application is an application to
which item 5 or 6 applies 300 (b) if the application is an application to
which item 4 (c) (ii) applies nil (c) in any other case 2,000 3 Application fee for the purposes of paragraph
23 (c) of the Act for listing of therapeutic
goods: 60 4 Evaluation fee for the purposes of subsection
24 (1) of the Act in respect of a drug
evaluated by the Drug Evaluation Branch of the
Department involving the evaluation of:
(a) human clinical information 34,700 (b) animal toxicological information 17,400 (c) chemistry, quality control and
manufacturing information:
(i) major evaluation 6,400 (ii) minor evaluation 2,900 5 Evaluation fee in respect of a drug to which
item 4 does not apply 1,700 6 Evaluation fee for the purposes of subsection
24 (1) of the Act in respect of a therapeutic
device where the device is evaluated on the
basis that it is substantially equivalent to
another device:
(a) if the evaluation involves human
clinical information 7,000 (b) if the evaluation does not involve
human clinical information 1,700 7 Evaluation fee in respect of a therapeutic
device to which item 6 does not apply:
(a) involving extensive human clinical
information 23,000 (b) involving minimal clinical information 11,600 8 Application fee for the purposes of paragraph
37 (1) (g) of the Act 300 9 Inspection fee for the purposes of paragraph
38 (1) (c), 41 (1) (f) or 58 (3) (b) of the
Act:
(a) if the fee is in relation to the
manufacture of a single type of therapeutic
device that is required, or is represented, to
be sterile 2,600 (b) if the fee is in relation to the
manufacture of therapeutic goods to which
paragraph (a) does not apply that are
required, or represented, to be sterile 5,200 (c) if the fee is in relation to the
manufacture of therapeutic goods that are
neither required to be, nor represented as
being sterile 3,500 (d) if the fee is in relation to a single
step in the manufacture of therapeutic goods 1,750 (e) if the fee is in relation to the
manufacture of ingredients or components for
use in the manufacture of therapeutic goods
and paragraph (d) does not apply 1,750 10 Fee for the issue to a person of a
certification under paragraph 58 (3) (a) of
the Act in respect of therapeutic goods where
a certification has not been issued in the
current financial year to the person in
relation to goods that are the same as the
goods to which the fee relates 300 11 Fee for the inspection of manufacturing
operations other than for the purposes of Part
4 of the Act The fee applicable
under item 9 for that step of manufacture
12 Fee for an evaluation of data concerning
therapeutic goods by the Department other than
for the purposes of Part 3 of the Act The fee applicable
under item 1, 4, 5, 6 or 7 for an
evaluation of that
nature
13 Fee for an evaluation under subsection 66 (4)
of the Act The fee applicable
under item 1, 4, 5, 6 or 7 for an
evaluation of that
nature