Australian Regulatory Guidelines
Australian government\’s Department of Health has approved a guidance 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 Therapeutic Goods Administration (TGA) is part of the Australian Federal Government\’s Department of Health and Ageing and is responsible for regulating therapeutic goods. The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market. It also assesses the suitability of medicines and medical devices for export from Australia and regulates manufacturers of therapeutic goods to ensure that they meet acceptable standards of manufacturing quality.
The guidance for the proposed Therapeutic Goods Advertising Code 2018 is still under development and will be consulted on from mid-June 2018.
Medical device consulting
Operon Strategist is a medical device consulting company which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
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
