We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
About faecal microbiota transplant products
Faecal microbiota transplant (FMT) products contain stool material from healthy donors. They help restore gut bacteria in patients with certain infections. Examples include fresh and frozen stool preparations and encapsulated stool capsules.
FMT products must be included in the Australian Register of Therapeutic Goods (ARTG) before supply. You are responsible for ensuring these products meet quality, safety, and effectiveness standards.
We assess applications (if necessary), monitor safety, and enforce regulations to protect public health 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.
