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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Handling of advertising complaints
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.
Effective handling of complaints enables advertisers of therapeutic goods to comply with legislative requirements, be socially responsible and assist in delivering good health outcomes. Complaints about advertising are currently considered by us or one of a number of industry associations depending on the advertiser, type of product and the medium in which the advertisement appeared.
We will become the single body responsible for handling complaints about the advertising of therapeutic goods to the public from 1 July 2018. The decision for us to consolidate all complaints about the advertising of therapeutic goods to the public will simplify and streamline the process and address many of the criticisms made about the current disjointed arrangements.
Complaints Resolution Panel
We have established transition arrangements with the Complaints Resolution Panel (the Panel) to minimise inconvenience to complainants. Until now, the Panel has been the primary body responsible for handling complaints about advertising to consumers. Where the Panel was unable to obtain compliance from the advertiser, it would refer the matter to us for follow up action. TGA's policy is to publish the outcomes of investigations into such complaints. We report outcomes based on whether:
- advertising compliance is achieved following TGA intervention or the complaint is closed due to other reasons
- a Regulation 9 order is issued
We will publish new arrangements for the publication of outcomes when we introduce the new complaints handling processes.
Lodging a complaint
Anyone may lodge a complaint about an advertisement for therapeutic goods. All complaints are treated in confidence unless the complainant consents to the release of their personal details. We also accept anonymous complaints.
To make a complaint, you can either:
- email TGA at firstname.lastname@example.org
- send a written complaint to:
Regulatory Practice, Education and Compliance Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
When a complaint is lodged, the following details should be included where possible:
- the name of the advertiser
- a copy of the advertisement
- the name of the publication and the date published (if applicable)
- details of what it is about the advertisement that the complainant finds unacceptable
See commonly recorded breaches of the Act and the Code as a guide.
You can find more information about how we may use personal information received in a complaint on the Privacy page of the TGA website.