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Tech Alert: TGA consultation on discontinuing Active / Herbal Proprietary Ingredients and some Excipient PIs

14 Jan 2021 8:37 AM | Anonymous member (Administrator)

The TGA have released the public consultation on discontinuing new applications for Proprietary Ingredients (ingredient mixes) in the Proprietary Ingredients Table, specifically for Active Ingredient mixes (such as ingredients containing vitamins or minerals), Active Herbal mixes, as well as the non-specific excipient category (other excipient mix categories are unaffected).

PIs are blends of ingredients that the supplier enters into the TGA database and obtains a number which sponsors can then use to add those ingredient mixes to their ARTG listing (or registration).

Please read today’s technical alert for more information, noting that this alert contains important information relevant to CMA members that is not included in the public consultation document.

n particular, there is information about the member response to the consultation, and further information about potential effects. We welcome all member feedback by Committee and also offline.

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