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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.
The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
This guidance is effective from 1 July 2018, unless otherwise specified.
Sections of this guidance are still under development. We will be adding information to the ARGATG in stages.
This guidance informs advertisers (including sponsors, manufacturers, importers, pharmacists and health professionals) of their responsibilities when advertising therapeutic goods. All advertising of therapeutic goods is subject to the requirements of the Therapeutic Goods Act 1989 (the Act). For those therapeutic goods that can be advertised to the public, advertising must comply with the requirements of the Act and the Therapeutic Goods Advertising Code (the Code).
The Therapeutic Goods Administration (TGA) is responsible for administering the Act and the Code. We have the authority to apply penalties with various consequences for advertisers who do not meet their advertising requirements.
If you are a member of the public and are interested in how therapeutic good advertising is regulated or would like to make a complaint about an advertisement, please see the TGA website: Advertising therapeutic goods.
This guidance provides information to advertisers about:
- the advertising regulatory framework
- advertising different types of therapeutic goods
- restricted representations
- pre-approvals for advertising
- sanctions and penalties for non-compliant advertising
- activities that represent advertising
- advertising therapeutic goods with related services
- advertising specific types of therapeutic goods
- advertising interface products
- handling of advertising complaints
For additional educational tools and fact sheets to help you understand your advertising requirements, see Advertising therapeutic goods on the TGA website.
This guidance has been developed by TGA and therefore the use of 'we' and 'us' throughout refers to TGA.
All examples provided in this guidance have been compiled to demonstrate the application of the legislation.
See the TGA glossary for definitions relevant to the regulation of therapeutic goods in Australia.