EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 53
THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 30 of the Therapeutic Goods Act 1966 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Sub-section 5(8) of the Act provides that a reference in the Act to goods for therapeutic use does not include a reference to goods for use in, or in connection with, inter alia, testing for pregnancy and contraception unless the goods are declared, or are included in a class of goods that are declared by the regulations to be goods for therapeutic use to which the Act applies.
Section 23M of the Act, inter alia, authorises the Director-General to require a prescribed corporation
that supplies or produces therapeutic goods in Australia to furnish information about those goods. However information about therapeutic goods that consist of a substance, namely pharmaceutical preparations, does not have to be furnished unless those preparations are prescribed in regulations and the information relates to prescribed matters.
The regulations amend the Therapeutic Goods Regulations (‘the Regulations’), consequential to the amendment of the Act by Part V of the Health Acts Amendment Act 1981. The Health Acts Amendment Act provided, inter alia, for the establishment of the National Register of Therapeutic Goods. However, as stated above, under section 23M of the Act, goods that consist of a substance must be prescribed in the Regulations before information about those goods can be supplied for the National Register.
The Minister for Health approved the inclusion of certain therapeutic goods in the National Register. The regulations give effect to that approval by inserting a new regulation 4A and a new Part 1A which provide for the
National Register of Therapeutic Goods.
Regulation 4A provides that therapeutic goods used for pregnancy testing and contraception are declared to be goods to which sub-section 5(8) of the Act applies.
Part 1A consists of regulations 4B and 4C. Regulation 4B provides that goods for therapeutic use that consist of a substance, being goods other than:
• homeopathic goods;
• diagnostic goods for in vitro use other than for diagnosing pregnancy;
• goods for use as an ingredient or component in the preparation or manufacture of a substance or article for therapeutic use; and
• 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.
Regulation 4C prescribes information relating to therapeutic goods which is to be provided for the purposes of paragraph 23M(2)(b) of the Act. The information to be
prescribed consists of:
• the proprietary name of the goods;
• the name and address of the manufacturer of the goods;
• the identity and address of the person responsible for the quality and safety of the goods in Australia;
• the non-proprietary name of each substance in the goods;
• the content of each of the active substances in a dosage unit of the goods;
• the dosage form of the goods;
• the route of administration of the goods;
• the labelling of the goods and the labelling of the packaging used in relation to the goods; and
• the explanatory printed material accompanying the goods.
A minor machinery amendment was also made to the Regulations by the repeal of regulation 3, which cited the parts into which the regulations were divided.