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Complying with advertising requirements
24 December 2021: The 2021 Advertising Code took effect on 1 January 2022 and will be subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply. The Advertising Code guidance has been updated to reflect changes to the Code. Further changes will be made to advertising education and guidance material over the coming months.
The Act sets out the legislative requirements for therapeutic goods, including the requirement to comply with the Code and includes offence provisions relating to advertising. Importantly, the Act prohibits the unauthorised use of restricted and prohibited representations.
Unless otherwise authorised, the Act prohibits references in advertising to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, and biological products.
For those therapeutic goods that can be advertised to the public, advertising must comply with the requirements of the Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).
This page sets out guidance to assist advertisers in complying with the Code.
Guidance on complying with the 2018 Code can be found at Advertising to the public. This will remain available during the transition period ending 30 June 2022 after which only the 2021 Code will apply, and the 2018 Code will be repealed.
For additional information also refer to the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG). Updates to these subsets of guidance will occur during 2022.
About the Therapeutic Goods Advertising Code
The Code sets out the rules that govern the advertising of therapeutic goods to consumers.
Learn about the Therapeutic Goods Advertising Code instrument, what has changed in this Code compared to the previous version, and how to read and interpret it.
Guidance on applying the Advertising Code
Some fundamental requirements apply to advertising of all types of therapeutic goods.
In this section we'll help you consider how to comply with the Code including on how to:
- say your product is included in the Australian Register of Therapeutic Goods (ARTG) without saying 'TGA approved'
- ensure your ad is accurate, truthful and not misleading
- deal with product comparisons
- maintain consistency with information included in the product's ARTG entry
- support the safe and proper use of therapeutic goods
- use endorsements and testimonials in advertising
- reference scientific or clinical information
- advertise lawfully to children
- offer authorised samples of goods
- align with public health campaigns.
Read more of the Guidance on applying the Advertising Code.
Restricted and prohibited representations
This section informs how to seek TGA approval to use restricted representations.
Representations which refer to serious forms of a disease, condition, ailment or defect, are restricted representations. These require approval from the TGA to be used in advertising. Section 28 of the Code specifies what is meant by 'serious form' in this context.
Advertisers should note that if a statement is required by law to be included in an advertisement and the statement is a 'restricted representation', approval for its use is not required.
In accordance with section 42DJ of the Act, the types of representations that are 'prohibited' no longer appear in the Code. They are specified in Part 1 of Schedule 2 to the Regulations.
Learn more about restricted and prohibited representations.
COVID-19 testing statements in advertising
Learn how advertisers can include statements about COVID-19 testing in advertising therapeutic goods on the COVID-19 testing statements in advertising page.
Requirements for COVID-19 rapid antigen tests
Testing service providers and suppliers of COVID-19 rapid antigen tests must ensure that advertising of these goods comply with the requirements set out in the Therapeutic Goods (Restricted Representations - COVID-19 Rapid Antigen Tests) Permission 2021, as well as the advertising requirements set out in the Act and the Code.
Read more about the Requirements for COVID-19 rapid antigen tests.
Requirements for specific product types
Some additional requirements apply to advertising particular types of therapeutic goods.
This section details these requirements for:
- prescription-only and pharmacist-only medicines
- complementary medicines
- vitamins and minerals
- weight management goods
Read more on the requirements for specific product types.
Applying the Advertising Code when naming therapeutic goods
The Therapeutic Goods Advertising Code applies to all therapeutic goods, including unapproved therapeutic goods.
When naming therapeutic goods, there are matters to consider so as not to contravene the Code. View the guidance on applying the Advertising Code when naming therapeutic goods.
Advertising health services
This section provides guidance on advertising health services.
Advertising for services that inherently involve therapeutic goods, need to comply with:
- the legislative requirements for advertising therapeutic goods
- any requirements governing the advertising of services
- the prohibition on advertising certain goods to the public.
Advertising to health professionals
Therapeutic goods advertisements that are only directed to health professionals or related entities may be exempt from the requirements of the Advertising Code if they are not accessible to consumers.
For advertisements of this nature which are in the public domain and can be accessed by consumers, the Advertising Code rules will apply.
Therapeutic Goods Advertising Compliance Education Strategy and Plan
The Therapeutic Goods Advertising Compliance Education Strategy outlines the approach the TGA will use to identify, engage with, and educate stakeholders about advertising requirements.
The Therapeutic Goods Advertising Compliance Education Plan outlines our compliance education priorities and planned activities.
In 2022 the TGA will undertake a consumer education campaign to aid consumers in their understanding of:
- the purpose of mandatory statements
- why mandatory statements appear in advertisements
- What steps to take when they see a mandatory statement.
To contact the TGA about advertising of therapeutic goods