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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.