The TGA has published outcomes of the consultation on proposed low-negligible risk changes to the Permissible Ingredients Determination, which occurred in August - September 2023.
These changes relate to:
New warning statements for -
- Curcuma species/curcumin (turmeric)
- Camellia sinensis (green tea)
Changed requirements for -
- soy phosphatidylserine
- Kakadu plum
The final changes will commence on 1 March 2024, after which new (or newly 'grouped') medicines that are released for supple 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 2025.
Please read today's full Tech Alert for more information and details. If members identify that further clarification of the drafted entries for the Determination are required, please contact email@example.com as soon as possible so we may contact the TGA about such updates before the Determination is due to be updated.