Consultation: 2022-2023 Proposed changes to the Permissible Ingredients Determination - Low-negligible risk

The Therapeutic Goods Administration (TGA) is 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:

1. Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata
2. Liver injury associated with Valeriana officianalis

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 the TGA to ensure that all ingredients are safe for use in low-risk medicines.

Timetable

The consultation opened on Thursday 4 August 2022. Interested parties responded by close of business Thursday 15 September 2022.

Please see the Schedule for annual low-negligible risk changes.

Enquiries

For enquiries relating to the consultation document or your submission please email listed.medicines@health.gov.au.

All recent TGA consultations can be found at the TGA consultation hub.