A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2022 will commence on 1 March 2022.
This Technical Alert includes a list of changes for sponsors, manufacturers and raw material suppliers to use to assist in identifying the changes to the Determination. Please note that this alert contains more detailed and specific comparative information about the changes than the summary published on the TGA webpage.
This alert details:
- NEW ingredients and specific requirements that apply to that ingredients
- CHANGED ingredients with the original requirements and the new or changed requirements.
- DELETED ingredients if applicable
For ingredients that have changed:
- Sponsors should review affected products for changes to compliance requirements (this may include increased or decreased regulatory requirements).
- Suppliers of raw materials, especially proprietary ingredients, should also ensure that changes to ingredients are checked against materials. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so they can remain in compliance with their legal obligations under the Therapeutic Goods Act 1989. The TGA expect sponsors to obtain correct information from suppliers to meet obligations, and for suppliers to provide the necessary and correct information to sponsors (including contacting sponsors when there are changes to ingredients or requirements that may affect compliance).