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Section 7 declarations - food or therapeutic good?

Section 7 declarations are made under the Therapeutic Goods Act 1989 (the Act) to provide greater clarity for consumers, the food and medicines industries and regulators in determining whether a product is a food or a therapeutic good.

Essentially, a section 7 declaration enables the Secretary to the Department of Health to declare that particular goods or classes of goods are or are not therapeutic goods. Goods or classes of goods that are declared to be therapeutic goods via a section 7 declaration must be included on the Australian Register of Therapeutic Goods (ARTG).

A declaration does not necessarily mean that a product, or class of products, is approved for supply in Australia. It is the responsibility of sponsors to make an application to have particular products included on the ARTG if they have not already done so.

The Act was amended, with effect from 27 November 2002, to stipulate that 'therapeutic goods' include goods that have been declared to be therapeutic goods under section 7 of the Act, even if they are also goods for which there is a prescribed standard in the Australia New Zealand Food Standards Code.

Declarations made

Content last updated: Thursday, 3 April 2014

Content last reviewed: Thursday, 3 April 2014

Web page last updated: Thursday, 3 April 2014

URL: http://www.tga.gov.au/industry/cm-section7.htm