End of pre-approval process for ads in specified media

From 1 July 2020, medicine advertisements in specified media do not need pre-approval from the Therapeutic Goods Administration (TGA). The TGA will continue to regulate the advertising of therapeutic goods, and advertisers must still meet the requirements under the therapeutic goods legislation, including the Therapeutic Goods Advertising Code.

Until 30 June 2020, advertisers must seek pre-approval under the Therapeutic Goods Regulations 1990 for ads about medicines that will be broadcast or published in 'specified media'. Specified media includes:

• magazines
• newspapers
• newsletters
• catalogues
• cinema advertising
• public displays about goods, including posters, billboards and displays in or on public transport.

The legislation requiring this pre-approval ends on 30 June 2020.

The change is a result of a recommendation from the Expert Review of Medicines and Medical Devices Regulation that the pre-approval scheme be stopped in favour of more self-regulation. The mandatory pre-approval scheme will not be replaced by any other statutory vetting scheme.

Although pre-approval will no longer be necessary from 1 July 2020, the regulation of advertising content remains, with the onus on advertisers to ensure that their ads meet the requirements under the therapeutic goods legislation and advertising code.

A broader range of enforcement powers have been put in place to support a greater self-regulatory approach. Advertisers should be aware that there is a range of offences relating to the unlawful publication or broadcast of a therapeutic product advertisement.

To help avoid non-compliance, guidance on the advertising requirements can be found on the TGA website.

In addition, the TGA is aware that a number of businesses offer advisory services to advertisers. If you are unsure whether your proposed ad will meet the requirements you may choose to obtain the services of one of these providers.

Please note that this legislative change does not impact on the requirement for approval for the use of restricted representations in advertising. This approval requirement will remain.

We have published a list of Q&As to assist advertisers.