Statutory Rules 1984 No. 531

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Therapeutic Goods Regulations2 (Amendment)

I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Therapeutic Goods Act 1966.

Dated 29 March 1984.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

NEAL BLEWETT

Minister of State for Health

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Principal Regulations

1. In these Regulations, “Principal Regulations” means the Therapeutic Goods Regulations.

Repeal of regulation 3

2. Regulation 3 of the Principal Regulations is repealed.

3. After regulation 4 of the Principal Regulations the following regulation and Part are inserted:

Goods for therapeutic use to which the Act applies

“4a. For the purposes of sub-section 5 (8) of the Act, goods included in each of the following classes of goods are declared to be goods for therapeutic use to which the Act applies:

(a) goods for use in, or in connection with, testing for pregnancy;

(b) goods for use in or in connection with, contraception.

“PART 1a—NATIONAL REGISTER OF THERAPEUTIC GOODS

Goods to which section 23m of the Act applies

“4b. Goods for therapeutic use that consist of a substance, being goods other than—

(a) homoeopathic goods;

(b) diagnostic goods for in vitro use other than for diagnosing pregnancy;

(c) goods for use as an ingredient or component in the preparation or manufacture of a substance or article for therapeutic use; or

(d) goods in the process of being prepared or manufactured for therapeutic use,

are declared to be goods to which section 23m of the Act applies.

Prescribed matters for the purposes of paragraph 23m (2) (b) of the Act

“4c. For the purposes of paragraph 23m (2) (b) of the Act, each of the following matters is prescribed:

(a) the proprietary name of the goods;

(b) the name and address of the manufacturer of the goods;

(c) the identity and address of the person responsible for the quality and safety of the goods in Australia;

(d) the non-proprietary name of each substance in the goods;

(e) the content of each of the active substances in a dosage unit of the goods;

(f) the dosage form of the goods;

(g) the route of administration of the goods;

(h) the labelling of the goods and the labelling of the packaging used in relation to the goods;

(j) the explanatory printed material accompanying the goods.

NOTES

1. Notified in the Commonwealth of Australia Gazette on 5 April 1984.

2. Statutory Rules 1970 No. 165 as amended by Statutory Rules 1973 Nos. 76 and 225; 1974 No. 166; 1975 No. 36; 1979 No. 135.