Therapeutic Goods Amendment Regulations 1998 (No. 3) 1998 No. 369
EXPLANATORY STATEMENT
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.
Overview
The Therapeutic Goods Amendment Regulations 1998 (No. 3) were enacted to amend existing regulations under the Therapeutic Goods Act 1989, primarily to address the forthcoming change of name of the Nutritional Foods Association of Australia to the Complementary Healthcare Council of Australia, effective from 1 January 1999. This legislative update ensures the continued participation of the renamed association in key advisory committees, such as the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council, by substituting the new name and including savings provisions to maintain the continuity of existing committee members. Furthermore, the amendments permit the use of certain low-risk substances as active ingredients in listable therapeutic goods, facilitating the introduction of new products in the Australian market. These changes were issued by authority of the Minister for Health and Aged Care, aiming to streamline the regulatory framework and enhance industry compliance while maintaining safety and efficacy standards.
Scope and Application
The Therapeutic Goods Amendment Regulations 1998 (No. 3) amends various provisions under the Therapeutic Goods Act 1989 to reflect changes in the nomenclature of the Nutritional Foods Association of Australia, now known as the Complementary Healthcare Council of Australia. These amendments apply to entities and individuals involved in the manufacturing, advertising, and distribution of therapeutic goods, particularly those associated with complementary medicines. The regulations are applicable nationally, given the federal nature of the Therapeutic Goods Act, which oversees the regulation of therapeutic goods across Australia. These amendments ensure that the new name is recognised in the regulatory framework and maintain continuity in the membership of key advisory committees, such as the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council. The amendments also update the Australian Register of Therapeutic Goods to include new low-risk substances as active ingredients in listable therapeutic goods, facilitating the introduction of new products in the market. However, it should be noted that these regulations do not alter the fundamental scope or application of the Therapeutic Goods Act, but rather refine specific administrative and technical details to ensure effective implementation of the law.
Key Provisions
The Therapeutic Goods Amendment Regulations 1998 (No. 3) make several amendments to existing regulations under the Therapeutic Goods Act 1989. The most significant changes relate to the substitution of the name "Nutritional Foods Association of Australia" with "Complementary Healthcare Council of Australia" in various sections of the Regulations (regs 1, 2, 5B, 5Q, 42C, 42E, 42K, 42T, 42Y). This change takes effect from 1 January 1999, and includes provisions to ensure that current members of relevant committees can continue their roles without interruption. These committees include the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council, which provide advice and undertake functions related to the advertising of therapeutic goods (s 63(2)).
The Regulations impose specific obligations on the Complementary Healthcare Council of Australia. For instance, the Council is permitted to nominate a member to the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council (reg 42C). Additionally, the Secretary of the Department of Health can delegate the power to approve advertisements for certain therapeutic goods, specifically complementary medicines, to the Council (reg 42T). Furthermore, the Regulations provide that the Secretary can delegate the power to approve advertisements for designated therapeutic goods that are complementary medicines to the Council (reg 42T).
There are also amendments to Division 5 of Schedule 4 of the Therapeutic Goods Regulations, which concern the inclusion of new substances as active ingredients in listable therapeutic goods. The Regulations aim to allow a range of new substances to be used in listable therapeutic goods and clarify the conditions under which the herbal substance Piper methysticum (kaya) can continue to be used in these goods (s 17(4)). These substances are considered low risk because they are safe for their intended use or are safe with appropriate dosage restrictions. Allowing these substances in listable therapeutic goods will facilitate the introduction of new products in Australia.
Breaches of the Therapeutic Goods Regulations may result in various civil and criminal penalties. For instance, advertising therapeutic goods without approval can lead to fines up to $22,000 for individuals and $110,000 for bodies corporate (s 92). More serious offences, such as knowingly supplying therapeutic goods that do not comply with the standards, can result in fines up to $550,000 for individuals and $2.75 million for bodies corporate, as well as imprisonment for up to five years (s 93). The Regulations also include provisions for the seizure and destruction of non-compliant goods (s 94). The amendments made by these Regulations ensure compliance with the Act and maintain the integrity of the therapeutic goods market in Australia.