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Tech Alert: Consultation outcome - Discontinuing Active/Herbal Proprietary Ingredients and some Excipient PIs

20 Jul 2021 12:30 PM | Anonymous member (Administrator)

The TGA have announced the outcomes of the Feb 2021 consultation: ‘Removing redundant processes for entering certain formulation information into a therapeutic goods application.’ As initially proposed, the TGA intend to stop entering three categories of new PI formulations into the Proprietary Ingredients Table before they are selected into an application onto the ARTG:

  • ingredient mixtures that contain an active ingredient (known as ‘Active Premixes’ and ‘Active Herbal Extracts’); and
  • non-specific ‘Excipient Mixes’, which the TGA consider do not provide sufficient information on the purpose of the mixture.

Existing ARTG entries that use PI numbers with an active ingredient or non-specific purpose in their formulation will remain active. Sponsors do not have to make changes or update ARTG entries if they include PI numbers with these categories in their formulation.

Notifications for new ingredient mixtures with an active ingredient or a non-specific purpose into the Proprietary Ingredients Table will stop being processed by the TGA as of today, 20 July 2021.

Please read today’s full technical alert for more information including the processes for, and impacts of these changes as well as CMA’s communication with the TGA in relation to these changes and associated considerations.

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