We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.
The Therapeutic Goods Administration (TGA) is conducting a public consultation and seeking feedback from interested parties on proposed changes to the requirements of ingredient used in listed medicines. The proposals address the following issues:
Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata
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.
The consultation opened on Thursday 4 August 2022. Interested parties must respond by close of business Thursday 15 September 2022.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.