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Complying with advertising requirements
This section informs advertisers, including manufacturers, pharmacists and health professionals, of their responsibilities when advertising therapeutic goods. It also informs our stakeholders of our advertising compliance strategy and plan.
All therapeutic goods advertising is subject to the requirements of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations).
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).
Please refer to the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) and additional guidance to help advertisers comply with the Code.
- General advertising requirements
Some fundamental requirements apply to advertising of all types of therapeutic goods.
In this section we'll help you consider how to say your product is included in the ARTG without saying 'TGA approved', ensure your ad is accurate, truthful and not misleading, deal with product comparisons, maintain consistency with information in the product's ARTG entry and support the safe and proper use of therapeutic goods.
We also discuss the use of endorsements and testimonials in advertising, references to scientific or clinical information, advertising lawfully to children, offering authorised sample products and alignment with public health priorities.
- Restricted and prohibited representations
Limitations apply to the use of certain representations, including serious forms of a disease, condition, ailment or defect, which require approval from the TGA to be used in advertising.
This section includes information about representations which are considered restricted or prohibited and how to request TGA approval to use these representations.
- Mandatory statements and product details
Medicines, devices and other therapeutic goods require particular statements and product details to be included in advertising.
These provide information about the product, warnings about the product's use and guidance for consumers to seek assistance if required.
- COVID-19 testing statements in advertising
This section sets out how advertisers can include statements about COVID-19 testing in advertising therapeutic goods.
- Requirements for specific product types
Some additional requirements apply to advertising particular types of therapeutic goods.
This section includes details of these requirements for prescription-only and pharmacist-only medicines, complementary medicines, vitamins and minerals, weight management products and sunscreens.
- Requirements for COVID-19 rapid antigen tests
Suppliers of COVID-19 rapid antigen tests and testing service providers need to ensure that all advertising of these products 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.
- 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 certain requirements that need to be met so as not to contravene the rules.
The name of a good forms a part of the advertising because it is present on the label, the packaging and in any marketing material that is available to consumers.
- Advertising for health services
Advertising for services that inherently involve therapeutic goods, need to comply with the legislative requirements for advertising therapeutic goods as well as any requirements governing the advertising of services.
This section provides guidance on how to legally promote health services administering or prescribing cosmetic injectables, medicinal cannabis, compounded medicines, vaccines, biologicals and disease education.
- Advertising to health professionals
Most of the regulations for advertising therapeutic goods apply only to those targeting consumers.
This section explains how to direct therapeutic goods advertising exclusively to health professionals so that the consumer advertising requirements do not apply.
For some goods that are only sold to health professionals or related entities, advertisers may want the advertising to appear in the public domain but it still needs to be compliant. Find out more at: Advertising therapeutic goods that are only sold to health professionals.
- 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, detailed activities and timings against these.