Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 1998 (NO. 3) 1998 NO. 369

STATUTORY RULES 1998 No. 369

Issued by Authority of the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 1998 (No. 3)

Subsection 63 (1) of the Therapeutic Goods Act 1989 (the Act) provides that the Governor-General may make regulations prescribing, among other things, matters necessary or convenient for carrying out or giving effect to the Act.

Subsection 63(2) further provides that the regulations may make provision in relation to the establishment of committees to advise the Minister or the Secretary on matters relating to therapeutic goods, and the functions and powers of those committees.

The purpose of the amendments to regulations 1, 2, 5B, 5Q, 42C, 42E, 42K, 42T and 42Y of the Principal Regulations is to reflect the change of name of the Nutritional Foods Association of Australia to the Complementary Healthcare Council of Australia, which will come into effect on 1 January 1999.

The Nutritional Foods Association of Australia is an association with expertise in the area of complementary medicines and under the Regulations it is able to nominate a member of the Complaints Resolution Panel and of the Therapeutic Goods Advertising Code Council. These are committees established under the regulations to provide advice and undertake various functions in relation to the advertising of therapeutic goods. The Regulations also provide that the Secretary may delegate his power to approve advertisements for designated therapeutic goods that are complementary medicines to the Nutritional Foods Association of Australia. To ensure a smooth changeover, the amendments to the regulations substitute the new name from 1 January 1999 and also include savings provisions to ensure current members of the above Committees are able to continue their membership.

Subsection 17(4) of the Act provides that the regulations may prescribe the therapeutic goods, or classes of therapeutic goods, that are required to be included in either of the two parts of the Australian Register of Therapeutic Goods, one of which is to contain a list of "registrable" goods and the other a list of "listable" goods. Generally, registrable goods undergo more stringent scrutiny for safety, quality and efficacy, whereas listable goods are granted general marketing approval unless the Secretary is satisfied the goods are not safe for the purposes for which they are to be used, or the quality of the goods is not acceptable.

The purpose of the amendments to Division 5 of Schedule 4 of the Therapeutic Goods Regulations is to permit a range of new substances to be used as active ingredients in listable therapeutic goods, and to clarify the conditions under which the herbal substance Piper methysticum (kaya) can continue to be used in listable goods. Some of the substances proposed for inclusion are food ingredients or extracts. All the substances proposed for inclusion are recognised as being of low risk, because they are intrinsically safe, safe for their intended use or considered safe when appropriate restrictions are placed on dosage where necessary. Permission to use them in listable therapeutic goods will assist industry to launch new products in Australia.

The regulations also include minor amendments to oversights in a previous amendment. An incorrect reference to the National Health and Medical Research Council is corrected. A reference to Part 1 of Schedule 10, rather than the whole of Schedule 10, is included in paragraph 9A(1)(a). This was overlooked in the previous amendment to Schedule 10, when it was divided into two parts.

The Regulations commence on 1 January 1999.