Labelling and packaging for prescription medicines must be clear, accurate, in English and meet all applicable labelling standards and requirements.
Prescription medicines cannot be advertised to the public but may be advertised exclusively to certain health professionals. Advertising to health professionals is strictly controlled and must be evidence-based.
We monitor labelling and advertising to ensure compliance and to protect public health.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription 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.
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PageComparable overseas regulators (CORs): Requirements for indications
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GuidanceTips for sponsors, distributors and retailers on creating prescription medicine labels that are compliant with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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PageUnderstand the required boxed warning and class statements for opioids.
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GuidanceGuidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.
PI and CMI
Access requirements for prescriber and consumer medicine information.
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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User guideThis user guide outlines how to communicate effectively with consumers using the revised Consumer Medicine Information (CMI) template
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User guideThis user guide provides guidance about preparing the summary page for Consumer Medicine Information (CMI) documents.
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GuidanceThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
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GuidanceThis guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.
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PageA new form for providing Product Information (PI) has been published following recent amendments to the Act.
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PageUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver.
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PageApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
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FormsPrescription medicines Minor Variation E-form now available
Advertising
Learn rules and requirements for advertising therapeutic goods.
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PageInformation about what is considered advertising, if advertising is allowed for your product and using the Advertising Code.
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PageInformation for sponsors and advertisers about advertising codeine.
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PageHow we manage advertising compliance, and where to find information about enforcement outcomes.
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PageFind out answers to frequently asked questions about advertising cosmetic injection services and our guidelines.
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GuidanceThis guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
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PageInformation on the legal and regulatory framework underpinning our rules on advertising therapeutic goods.
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PageGLP-1 receptor agonists such as Ozempic (semaglutide) and its derivatives are regulated as prescription-only medicines.
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PageUnderstand our requirements for advertising price lists for therapeutic goods that are prohibited from advertising to consumers. Relates to Part 9 of the Advertising Code.
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GuidanceGuidance to help you understand requirements for disease information and advertising.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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GuidanceThis Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
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PageLearn what the requirements are associated with advertising therapeutic goods in relation to weight management.
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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.
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GuidanceGuidance about when information released to the public about therapeutic goods is considered advertising.
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PageLearn which therapeutic goods can and cannot be advertised to the public.
Product types