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.
After your faecal microbiota transplant (FMT) product is on the market, you have ongoing responsibilities to meet regulatory requirements.
You must:
Maintain your FMT’s entry in the Australian Register of Therapeutic Goods (ARTG)
notify us of any changes or variations to your product
pay annual charges
monitor safety
report issues
support post-market surveillance.
We oversee these activities to protect public health and ensure FMT products remain safe and effective in Australia. Understanding your responsibilities helps you stay compliant and maintain high product standards.
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.