Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 200

EXPLANATORY STATEMENT

STATUTORY RULES 1996 No. 200

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 a State or Territory. To achieve uniformity of regulation in respect of the manufacture and supply of therapeutic goods throughout Australia, 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 Commonwealth 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 New South Wales enacted its complementary legislation on 1 September 1996, and the Poisons and Therapeutic Goods Act 1966 is to commence from that day. Under the arrangements agreed between the Commonwealth and the States and Territories, the Commonwealth is to be delegated the relevant 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 declared the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 1994 to be "corresponding State law".

The Regulations commence upon Gazettal.