Clear and accurate labelling is essential for faecal microbiota transplant (FMT) products.
Labels must be in English, clear, durable and include key details in metric units.
As biologicals, FMT products cannot be advertised to the public, but may advertised exclusively to certain health professionals.
These rules support safe use, traceability, and public confidence. We monitor compliance to ensure products are promoted and used responsibly.
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 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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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.