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This consultation closed on 14 September 2023. The outcome of the consultation was published to the consultation hub on 1 December 2023.
Overview
We conducted a public consultation and sought feedback from interested parties on proposed changes to the requirements of ingredient used in listed medicines. The proposals addressed the following issues:
- Curcuma species and curcumin and the risk of liver injury
- Green tea extract and the risk of liver injury
- Safe levels of benzophenone
- Clarification of the requirements for Soy phosphatidylserine-enriched ingredients
- Clarification of the requirements for Terminalia ferdinandiana
These ingredients are included in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). This is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989 ('the Act'). This instrument specifies all of the ingredients that are available for use in listed medicines and the requirements for their use. The Determination is continually reviewed by us to ensure that all ingredients are safe for use in low-risk medicines.
Enquiries
For enquiries relating to the consultation document or your submission please email listed.medicines@health.gov.au.
All current TGA consultations can be found at the TGA consultation hub.