Requirements for microorganism characterisation for Listed Medicines and Registered Complementary Medicines

This guidance provides information for applications applying to use microorganisms as active ingredients in listed medicines or registered complementary medicines (RCM). Listed medicines and RCM containing microorganisms as active ingredients are generally referred to as probiotics or postbiotics.

This document provides tailored guidance that is not covered in the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines and ensures that microorganisms, when identified and characterised, are safe for their intended use in keeping with modern best practice.