Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 111

STATUTORY RULES 1995 No. 111

Issued by Authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 ("the Act") has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The application of the Act is limited by the Federal Constitution so that it cannot extend to regulate, for example, individuals who manufacture and supply therapeutic goods within that State or Territory. To achieve uniformity of regulation in respect of the manufacture and supply of therapeutic goods throughout Australia, complementary State and Territory legislation to complement the Act will be required.

Through the Australian Health Ministers' Advisory Council, State and Territory governments have agreed with the Commonweath that they will introduce "complementary legislation" to cover individuals and activities that cannot be covered by the Act under a truly national scheme of legislative controls. The State of Victoria enacted its complementary legislation in December 1994, and the Therapeutic Goods (Victoria) Act 1994 is expected to commence to operate on. 23 May 1995. Under the arrangements agreed to between the Commonwealth and the States and Territories, the Commonwealth is to be delegated the complementary powers and functions under State/Territory legislation. Before this can occur, such State enactments must first be declared to be a "corresponding State law" under the Therapeutic Goods Regulations for the purposes of section 6A of the Act.

Section 63 of the Act enables the Governor General to make regulations prescribing, among other things. matters necessary or convenient to be prescribed for carrying out or giving effect to the Act. Subsection 3(1) of the Act provides, that regulations may be made to declare a State law that corresponds with the Act to be a "corresponding State law" for the purposes of enabling State functions and powers under such laws to be delegated to the Secretary in accordance with section 6A of the Act

Accordingly, the amending Regulations will declare the Therapeutic Goods (Victoria) Act 1994 to be a "corresponding State law".

In addition, the amending Regulations will:

(a)       repeal Regulation 3. This regulation currently provides that for the ,purposes of subsection 6(3) of the Therapeutic Goods Act 1989, the State and Territory laws identified under this Regulation may continue to operate in conjunction with the Commonwealth's therapeutic goods legislation. However subsection 6(3) was repealed by the Health and Community Services Legislation Amendment Act (No. 2) 1993. Consequently, R.3 no longer has any effect and should therefore be removed; and

(b)       amend the definition of "Poisons Standard" in Regulation 3. Currently this definition identifies the National Health and Medical Research Council to be the publisher of the Poisons Standard. This no longer is correct. The correct publisher of that document is the Australian Health Ministers' Advisory Council. An amendment to the definition of "Poisons Standard" is therefore necessary.

The Regulations. commence on 1 June 1995.