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To legally supply faecal microbiota transplant (FMT) products in Australia, you must apply to include them in the Australian Register of Therapeutic Goods (ARTG).
FMTs are regulated as biologicals and must meet strict standards for safety, quality, and donor screening. You must provide evidence of compliance.
Apply through our Business Services Portal. We assess your application and documents to ensure regulatory standards are met. You must provide evidence of compliance or certify compliance, depending on biological class.
Apply through our Business Services Portal. Class 1 products are included following your certification that all legal requirements are met. Class 2 applications and documents are assessed to ensure regulatory standards are met.
Fees apply as part of the application process.
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.