EXPLANATORY STATEMENT
SUBJECT - THERAPEUTIC GOODS ACT 1989
THERAPEUTIC GOODS REGULATIONS 1990 No. 88
ISSUED ON THE AUTHORITY OF THE MINISTER FOR COMMUNITY SERVICES & HEALTH
The commencement date of the Therapeutic Goods Act 1989 (the Act), as a consequence of an amendment in the Senate, is the day after the Regulations are formally approved by both Houses (section 2).
Section 63 of the Act provides that the Governor-General may make Regulations which are not inconsistent with the Act. The Regulations may prescribe matters required by the Act or matters necessary to give effect to the Act. The Regulations relate to the following particular matters:
(a) prescribing State and Territory legislation which can operate concurrently with the Act (subsection 6(3)). Chapter 1 contains a list of these laws;
(b) prescribing requirements for advertising therapeutic goods (paragraph 63(2)(c)). Chapter 2 of the Regulations deals with this matter and defines prohibited and required representations in advertisements for therapeutic goods directed to the public;
(c) prescribing therapeutic goods which are required to be registered or listed or which are exempt from registration or listing (paragraph 17(4)(a) and subsection 18(1)). Chapter 3 of the Regulations defines the goods in each category and deals with the transfer of goods between the categories, provided for by paragraph 17(4)(b), or between sponsors, provided for by paragraph 63(2)(f);
(d) exempting goods or persons from the requirements of Part 4 of the Act which deals with the licensing of manufacturers of therapeutic goods (subsections 34(1) and 34(2)). Chapter 4 of the Regulations deals with the exemptions, matters related to conditions of holding a licence, provided for by paragraphs 40(4)(e) and 63(3)(c), and the transfer of licences, provided for by paragraph 63(2)(f);
(e) prescribing requirements for sampling and testing therapeutic goods (paragraph 63(2)(d). Chapter 5 of the Regulations deals with these matters;
(f) the establishment, functions and powers, and remunerations payable to members, of committees which advise the Minister or the Secretary on matters relating to therapeutic goods (paragraph 63(2)(a)). Chapter 5 of the Regulations deals with these matters;
(g) prescribing fees for functions carried out under the provisions of the Act including application fees for registration and listing (subsection 23(c) and paragraph 37(1)(g)), evaluation fees (paragraph 19(2)(b) (iii) and subsection 24(1)), fees for inspections of manufacturers (paragraph 63(2)(h) and a fee for providing information from the Register (subsection 32(2)). Fees also apply to services carried out at the request of a person (paragraph 63(2)(h)). Paragraph 63(3)(a) permits fees for different classes of goods or steps in manufacture.
Chapter 7 of the Regulations deals with these matters and with the waiver and reduction of fees provided for in paragraph 63(3)(b).
(h) prescribing information which may be released from the Register to a person (subsection 61(6)). Chapter 8 defines the information which can be released to a person and deals with delegations and review of decisions under the Regulations.
(i) prescribing penalties for offences against the Regulations which do not exceed $1000 in the case of a natural person and $5000 in the case of a body corporate (paragraph 63(2)(j)).
The Act also provides for regulations in relation to
• the storage and transport of therapeutic goods (paragraph 63(2)(b)). The provisions primarily relate to the handling of goods by wholesalers and regulations are not required whilst the States and Territories are prepared to deal with this matter.
• requirements for informational material that is included with therapeutic goods (paragraph 63(2)(e)). The regulations are not necessary at the present time.
Subsection 63(4) allows regulations to be framed in such a way that they refer to some aspect of another document. The reference may be to a particular edition of that document or to the most recent edition as amended from time to time. An example of this would be a regulation classifying goods for a particular purpose according to whether or not the goods are in a schedule of the NH&MRC’s Standard for the Uniform Scheduling of Drugs and Poisons (S.U.S.D.P).
Details of the Regulations are attached.
ATTACHMENT
DETAILS OF PROPOSED THERAPEUTIC GOODS REGULATIONS
Regulation 1 of Chapter 1 of the Regulations provides that these Regulations may be cited as the Therapeutic Goods Regulations. They commence on the day after the Regulations have been approved by both Houses of Parliament.
Regulation 2 is an interpretations provision which defines various terms used in the Regulations.
Regulation 3 defines the State and Territory legislation which can operate concurrently with the Therapeutic Goods Act. This is necessary as a precaution that the Act may inadvertently and adversely affect a State or Territory provision since State and Territory controls extend further than the quality, safety and efficacy of therapeutic goods.
Chapter 2 of the Regulations deals with requirements for advertising of therapeutic goods for use in humans to the public. Advertising includes statements on labels, information supplied with the goods and advertisements in the print and electronic media.
Regulation 4 excludes from the provisions of Chapter 2 advertising to specified health care workers and wholesalers of therapeutic goods who must be provided with full information on the therapeutic uses of goods.
Regulation 5 restricts the requirements of Chapter 2 to goods for use in humans.
Regulation 6 prohibits advertising to the public from promoting the use of therapeutic goods for medical conditions which should be treated under medical supervision or subsequent to medical advice. These medical conditions are listed in Schedule 1 of Regulation 8 as prohibited representations in advertisements. The Schedule also contains other prohibited representations relating to unacceptable claims as well as required representations for specified classes of therapeutic goods, which provide for public advertising to be accurate and relevant. The Regulation also prevents goods which can only be obtained with the prescription of a medical practitioner or a dentist or directly from a pharmacist being advertised to the public. Regulation 7 allows the Secretary to prevent a person publishing false or misleading advertisements.