Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 NO. 401

STATUTORY RULES 1997 No. 401

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Section 63 - of 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.

Paragraph 63(2)(c) of the Act allows regulations prescribing advertising requirements for therapeutic goods that are in the Australian Register of Therapeutic Goods.

The Therapeutic Goods Regulations deal with the advertising of therapeutic goods and prohibit certain claims or representations being made about therapeutic goods.

Therapeutic goods that are regulated under the Act include natural remedies that rely on herbs and other naturally occurring substances for their effect, rather than relying on synthetic substances made by pharmaceutical companies.

The need for the the amendments arose when a manufacturer of a natural remedy advertised its product as 'drug-free' when it was not.

The purpose of the proposed regulations is to make it clear that manufacturers, suppliers, importers or exporters of therapeutic goods cannot claim that a therapeutic good is 'drug-free' if that is not the case, as this would be false and misleading. The amendments will achieve this by prohibiting such false and misleading advertising.

The Regulations commenced on gazettal.

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

1.       Amendment

Regulation 1 states the Therapeutic Goods Regulations are amended as set out in these amending Regulations.

2.        Schedule 2 (Prohibited and required representations for the purposes of paragraphs 6(1) (a) and (b)

Regulation 2 amends Schedule 2 to the Therapeutic Goods Regulations by adding as a representation that must not be published in an advertisement, a representation that therapeutic goods are drug-free.