Clear labelling and responsible advertising help ensure human cell and tissue products are used safely and effectively.
If you supply human cell and tissue products, you must follow strict rules for labelling and packaging. Labels must be clear, accurate, and in English.
Public advertising of most of these products is banned.
We monitor compliance to protect public health and maintain trust. Knowing your responsibilities helps avoid penalties and supports safe use in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and 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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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.