Australian government’s Department of Health has approved a guidance i.e Australian Regulatory Guideline for advertisers that applies to the current Therapeutic Goods Advertising Code 2015 but incorporates an amendment to the Therapeutic Goods Act 1989 (the Act) that came into effect on the 6 March 2018.
The guidance for the proposed Therapeutic Goods Advertising Code 2018 is still under development and will be consulted on from mid-June 2018.
This guidance informs advertisers (including sponsors, manufacturers, importers, pharmacists and health professionals) of their responsibilities when advertising therapeutic goods to the public. All advertising of therapeutic goods to the public and health professionals must comply with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (the Code). The Therapeutic Goods Administration (TGA) is responsible for administering 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:
- advertising compliantly under the regulatory framework
- the requirements for advertising different types of therapeutic goods
- restricted representations and advertising
- pre-approvals that are needed before advertising
- enhanced sanctions and penalties for non-compliant advertising
- the kinds of activities that represent advertising
- advertising therapeutic goods with related services
- advertising specific types of therapeutic goods
- advertising interface products
- the handling of advertising complaints