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.