Changes to applying for the evaluation of a new substance

Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989, and accompanying guidelines are intended to come into effect in January 2023.

There will be a new way to apply for evaluation of a new substance for use in listed medicines. If you are planning to apply for evaluation of a new substance for use in listed medicines please contact complementary.medicines@health.gov.au for more information on the upcoming changes and how these might affect you.

A list of coming changes that are scheduled to be published in January 2023 are described below.

New mandatory requirements and guidelines documents

• Mandatory requirements for applications to vary the Permissible Ingredients Determination and accompanying guidelines
• Guidelines that outline requirements for microorganism characterisation in listed and registered complementary medicines
• Updated guidelines on using evaluation reports from Comparable Overseas Bodies (COB), a list of approved COBs and corresponding COB checklists
• Updated Australian Regulatory Guidelines for Sunscreens
• Updated compositional guideline templates

List of current documents in effect until January 2023

• Applications for new substances in listed medicines - Australian regulatory guidelines
• Guidelines on using evaluation reports from Comparable Overseas Bodies (COB), a list of approved COBs and COB checklists
• Australian regulatory guidelines for sunscreens (ARGS)
• Compositional guideline template