Clear labelling helps ensure biologicals are used safely and effectively.
Labelling and packaging for biologicals must be clear, accurate, and durable. Labels must be in English, easy to read, securely attached and include key details in metric units.
Biologicals cannot be advertised to the public but may advertised exclusively to certain health professionals. Advertising to health professionals is strictly controlled and must be evidence-based.
These rules help ensure safety, traceability, and public trust. We monitor compliance to protect consumers and support informed decisions.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. 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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PageFind information on labelling and packaging for medicines and biologicals.
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PageStandards for labels and packaging of medicines and biologicals.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
PI and CMI
Access requirements for prescriber and consumer medicine information.
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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.
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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PageHow we manage advertising compliance, and where to find information about enforcement outcomes.
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PageInformation on the legal and regulatory framework underpinning our rules on advertising therapeutic goods.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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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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ServiceIndustry portal. Ask a question about advertising therapeutic goods.
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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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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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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.