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Tech Alert: Outcomes of the Permissible ingredients consultation: B6; mollusc-derived ingredients; Artemisinin

17 Dec 2021 12:09 PM | Anonymous member (Administrator)

The TGA have published outcomes of the consultation on proposed low-negligible risk changes to the Permissible Ingredients Determination, which occurred in August-September 2021. These changes include amendments to:

 - Vitamin B6 containing products

 - Artemisinin containing products

 - Allergen statement for mollusc-derived ingredients

The final changes will commence on 1 March 2022, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.

For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2023

Please read today’s Tech Alert for more information and details.

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