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 email@example.com 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
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.