Certificates of Listing do not verify a product's efficacy nor do they constitute TGA endorsement of any claims made by sponsors in relation to listed products.

Sponsors are reminded that during the assessment of listing applications for drugs and devices, the proposed indications are not evaluated for efficacy. The claims are assessed to ensure compliance with the advertising requirements under the Therapeutic Goods Regulations only, ie. to ensure that the claims proposed are not prohibited representations, as specified by Clauses 4, 5.3, 6.1 and 7 of the Media Council of Australia's Therapeutic Goods Advertising Code (TGAC). These clauses have been adopted under the Therapeutic Goods Regulations.

Some clearance bodies operating under the co-regulatory system of advertising (administered by the Media Council of Australia and endorsed by the Trade Practices Commission), who pre-clear advertisements for therapeutic goods, have advised of continuing difficulties with some sponsors who submit a product's Certificate of Listing as "proof" of efficacy and verification of the truthfulness of claims contained in proposed advertisements (as required by TGAC Clause 3.1).

The Certificate of Listing is a formal legal document which certifies the act of listing, contains the product's individual listing number and itemises a range of standard conditions applicable to that product. The certificate may be used by sponsors to confirm that a particular product is entered on the Australian Register of Therapeutic Goods (ARTG), but in no way supports or verifies any of the claims made by the sponsor in relation to their product.

Sponsors are reminded of the standard condition of listing under Section 28 of the Therapeutic Goods Act 1989 - they must have and shall retain, while the goods remain listed, evidence to substantiate and support the accuracy of the indications in relation to the listed goods and, upon request of the Director, Compliance Branch or the Director, Therapeutic Devices Branch, shall produce such evidence. Sponsors are also reminded that products may be cancelled from the Register where standard conditions are breached or cannot be satisfied.

The TGA has advised nominated bodies for the pre-clearance of advertisements for therapeutic goods of the status of a Certificate of Listing - the Certificate will not be accepted as proof of efficacy or substantiation of claims contained in proposed advertisements.