A new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024 commences today, Friday 1 March 2024.
This technical alert provides members with a summary of changes as well as a comparison table of all changes to the Determination.
Important changes in this Determination include:
NEW ingredients for use in listed and assessed listed medicines and specific requirements that apply to those ingredients:
- Addition of the new active ingredient theanine with exclusive use provisions for 2 years;
-Addition of the new excipient ingredient ceramide 6 II;
Addition of the new excipient ingredient sodium lauroyl lactylate;
CHANGED ingredients including ingredients with NEW WARNINGS and other changed requirements:
- Curcuma aromatica; Curcuma longa (Turmeric); Curcuma zanthorrhiza; Curcuma zedoaria; and curcumin.
- Camellia sinensis (Green tea).
Ingredients with important changed requirements including
- Terminalia ferdinandiana (Kakadu plum); neohesperidin-dihydrochalcone (permitted for oral use in listed and listed assessed medicines); hemp seed oil, and other ingredients.
Please read today’s full alert for more details.