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Tech alert: New Permissible Ingredients Determination (No. 3) 2021

21 Oct 2021 4:30 PM | Anonymous member (Administrator)

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021 will come into effect on 25 October 2021.

This Technical Alert includes a list of changes for sponsors, manufacturers, 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 ingredient

-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 that they provide to sponsors and manufacturers. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so that 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 if there are changes to requirements that may affect ingredient or product compliance.

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