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Reminder: pre-approval for ads in specified media ends 30 June 2020
Changes for those who advertise medicines to the public using television, radio, print media, cinema, billboards or other public displays are effective from 1 July 2020.
Parliamentary changes to the Therapeutic Goods Act 1989 come into effect on 1 July 2020. Under these changes, medicine advertisements in specified media will no longer need pre-approval under the therapeutic goods legislation.
The Therapeutic Goods Administration (TGA) will continue to regulate the advertising of therapeutic goods, and advertisers must ensure their advertising is fully compliant with the therapeutic goods legislation, including the Therapeutic Goods Advertising Code.
Current pre-approval applications
If you are waiting for a decision on a current pre-approval application, or considering a new application, you should liaise with Consumer Healthcare Product Australia.
As it is unlikely that new applications will be decided prior to the end of the pre-approval scheme, applicants should be aware that the Therapeutic Goods Regulations 1990 does not allow for the refund of fees paid for pre-approval applications.
Know your responsibilities or talk to someone who knows the rules
Before you advertise therapeutic goods, it is your responsibility to understand the legislative requirements. Visit the Advertising hub on the TGA website and view our video to help you understand the requirements.
There is a range of offences relating to unlawful advertising.
Approval still required to advertise using restricted representations
The end of the pre-approval scheme does not affect the requirement for advertisers to obtain prior approval or permission from the TGA before using restricted representations in advertisements for therapeutic goods.
We have published a list of Q&As to assist advertisers.
The TGA Advertising hub contains a range of tools for both consumers and advertisers, including fact sheets, an e-learning module and forms for reporting illegal advertising and submitting enquiries.
Subscribe to the TGA Advertising email list to receive notification of updates and other important information specific to advertising.
We understand that the complexities of the therapeutic goods advertising legislation may be difficult to navigate. To obtain advice specific to your advertising, you may wish to seek independent legal advice or the assistance of a regulatory affairs consultant or advertising advisory service. You can find a list of organisations that may be able to assist you in finding a consultant on the TGA Website.