The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
This guidance applies to 'assessed listed medicines' that are eligible for evaluation by our Complementary and Over-the-counter Medicines Branch (COMB).
There are 3 types of medicines that may be supplied over the counter in Australia based on the level of risk of the ingredients and therapeutic indications of the medicine:
- listed medicines
- assessed listed medicines
- certain registered medicines (such as registered complementary medicines).
There are 3 application categories for assessed listed medicines, with different evidence requirements based on the level of evaluation:
- L(A)1
- L(A)2
- L(A)3.
This document provides guidance for the evidence requirements for all 3 application categories, with a focus on the L(A)3 application category as these require a de novo evaluation of efficacy.