TGA Waives Pre-Approval for Medicine Advertisements in Specified Media

Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media.

The advertising of therapeutic goods will still be regulated by  TGA and advertisers shall abide by the requirements of the therapeutics goods legislation which includes the Therapeutic Goods Advertising Code.

The document published by TGA states that advertisers will still require pre-approval for advertisements about medicines in accordance with Therapeutics Goods Regulations 1990. The pre-approval is only needed up to 30 June 2020 for ads published in magazines, newspapers, newsletters, catalogues, cinema advertising, public displays about goods, including posters, billboards, and displays in or on public transport. Pre-approval is not required effective 01 July 2020 onwards.

The Expert Review of Medicines and Medical Devices Regulations have proposed the change to promote self-regulation by advertisers.

The advertisers will however be required to ensure that the ads meet the requirements as per the advertising code and therapeutic goods legislation.  The self-regulatory approach is supported by a wide range of enforcements especially with the listing of offenses on the TGA website. The information provides a clearer picture of unlawful publication or broadcast of ads related to therapeutic products.

In the event advertisers require guidance on the self-regulatory steps, they may seek advisory services.
The requirement for approval for restricted representation still remains and is unaffected by the new legislation.

Advertisers may seek further information about  the legislation at

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