You must label and advertise your medicine in a way that protects consumers and supports safe use.
We set requirements for medicine labelling and packaging to ensure important information is clear, accurate and easy to read.
You must make sure that labels meet Australian standards, which includes ingredients, directions for use and safety warnings.
We also regulate how medicines are advertised to the public and health professionals. You must ensure advertising is truthful, balanced and not misleading.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.
Labelling and packaging
Find requirements for product labelling and packaging.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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PageAll medicines included in the Australian Register of Therapeutic Goods (ARTG) must include the relevant AUST number on the label.
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User guideA user guide on how to change sponsor details in PI and labels.
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PageInformation on the Code of practice for tamper-evident 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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GuidanceFind out whether your application for an umbrella-branded medicine requires a higher level of assessment.
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PageLabelling and advertising requirements for non-prescription medicines.
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PageRegulatory information on the labelling and packaging of medicines and medical devices
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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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PageLabelling requirements for ingredients that are included in the International Harmonisation of Ingredient Names (IHIN) project.
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PageMinor updates to clarify transition arrangements for medicine labelling requirements.
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PageFind information on labelling and packaging for medicines and biologicals.
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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.
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GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
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PageLearn about Required Advisory Statements for Medicine Labels (RASML).
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PageFind out about processes for updating RASML.
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PageA new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January 2023.
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PageStandards for labels and packaging of medicines and biologicals.
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LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
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LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
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PageTake care when prescribing, dispensing, and administering medicines as labels will start to show sole names.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
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GuidanceGuidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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PageOver time we've updated some medicine ingredient names used in Australia to align with names used internationally.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.
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GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
PI and CMI
Access requirements for prescriber and consumer medicine information.
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PageInstrument of Approval for Product Information (PI) in relation to medicine under subsection 7D(1) of the Therapeutic Goods Act 1989.
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User guideA user guide on how to change sponsor details in PI and labels.
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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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PageThe following form is approved for product information (PI) in relation to medicine under subsection 70(1)
of the Therapeutic Goods Act 1989. -
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PageThe PI/CMI search facility allows Product Information (PI) and Consumer Medicine Information (CMI) documents to be searched.
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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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User guideHow to get approved PI and CMI documents for OTC medicines published on our website.
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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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DatasetSearch notices of approved and permitted restricted representations.
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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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GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the public.
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GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
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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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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.
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GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
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GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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User guideApply for our approval to use a restricted representation in advertising.
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Decision treeUse this decision tree to help you understand if you can advertise a particular therapeutic good to the public.
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GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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PageHow advertising of therapeutic goods needs to be accurate, balanced and safe. This relates to Part 3 of the Advertising Code.
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PageUsing indications for non-prescription medicines.
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ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
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ServiceIndustry portal. Ask a question about advertising therapeutic goods.
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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.
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ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
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PageLearn what the requirements are associated with advertising therapeutic goods in relation to weight management.
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PageThere are restrictions on using representations in advertising that refer to certain diseases, ailments or conditions. Relates to Part 8 of the Advertising Code.
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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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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.
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PageExplore advertising information on specific topics, such as social media and goods like Ozempic. Find out ways to promote health services offering products that cannot be advertised to the public.
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PageRequirements for endorsements and testimonials shown in advertisements about therapeutic goods. Relates to Part 6 of the Advertising Code.
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PageFind out how claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
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PageThe trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.
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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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PageHow you can use terms such as 'natural' without misleading consumers.
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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.
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PageLearn which therapeutic goods can and cannot be advertised to the public.
Product types