Listed medicines must be labelled and advertised in a clear, truthful, and accurate way.
Labels and packaging must provide essential information such as product name, Australian Register of Therapeutic Goods (ARTG) number, ingredients, directions for use, and any warnings.
Advertisements for listed medicines must:
- promote safe and proper use of a listed medicine
- not mislead, deceive or create unrealistic expectations
- support informed health care choices.
Claims must be consistent with their permitted indications and must not be about treating serious illnesses, including conditions like influenza or chronic asthma.
We monitor advertising to ensure compliance. This stage ensures your listed medicine is labelled and promoted responsibly to protect consumers and meet legal obligations.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to listed medicines. You may also have to meet obligations that apply to all medicines and all products.
Labelling and packaging
Find requirements for product labelling and packaging.
-
PageLabelling and advertising requirements for non-prescription medicines.
-
GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
-
LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
-
GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
Advertising
Learn rules and requirements for advertising therapeutic goods.
-
PageInformation about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.
-
PageHow we manage advertising compliance, and where to find information about enforcement outcomes.
-
-
PageInformation on the legal and regulatory framework underpinning our rules on advertising therapeutic goods.
-
DatasetSearch notices of approved and permitted restricted representations.
-
GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
-
GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
-
PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general public.
-
GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
-
GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
-
GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
-
GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
-
GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
-
User guideApply for our approval to use a restricted representation in advertising.
-
GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
-
PageHow advertising of therapeutic goods needs to be accurate, balanced and safe. This relates to Part 3 of the Advertising Code.
-
PageAn overview of the types of information that must be included in advertisements about therapeutic goods. Relates to Parts 4 and 5 of the Advertising Code.
-
PageLearn what the requirements are associated with advertising therapeutic goods in relation to weight management.
-
PageThere are restrictions on using representations in advertising that refer to certain diseases, ailments or conditions. Relates to Part 8 of the Advertising Code.
-
ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
-
PageUnderstand what can be used as a free sample in therapeutic goods advertising and the rules around offering incentives. Relates to Part 7 of the Advertising Code.
-
PageRequirements for endorsements and testimonials shown in advertisements about therapeutic goods. Relates to Part 6 of the Advertising Code.
-
PageFind out how claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
-
PageThe trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.
-
LegislationThis Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
-
GuidanceGuidance about when information released to the public about therapeutic goods is considered advertising.
-
PageHow you can use terms such as 'natural' without misleading consumers.
-
PageThere are specific requirements for using scientific or clinical terminology in advertising or giving support to claims by referring to scientific research. Relates to Part 3 of the Advertising Code.
-
PageLearn which therapeutic goods can and cannot be advertised to the public.
Product types