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Purpose
This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in the Therapeutic Goods (Standard for Faecal Microbiota Transplant Products) (TGO 105) Order 2020 as prepared by the Therapeutic Goods Administration (TGA).
TGO 105 outlines the mandatory standards for FMT product providers, including all sponsors and manufacturers.
TGO 105 includes specific requirements to ensure the safety and quality of FMT products that are manufactured from both frozen and fresh stool.
This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter.
It should not be relied on to address every aspect of the relevant legislation. You should seek your own independent legal advice to ensure that all of the legislative requirements are met.
If you require clarification of a particular requirement, you can email TGA’s Biological Sciences Section (BSS): bloodandtissues@health.gov.au.