The TGA will no longer be assessing Herbal Component Names (HCN’s) as part of pre-market evaluations, effective immediately. Effective 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings.
Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. There is no legislative requirement to use non-mandatory herbal components for listing a medicine on the ARTG.
Existing ARTG entries will not be affected by this change. Sponsors will not be required to amend or remove any HCNs from their ARTG entries. Sponsors will not be able to add new non-mandatory HCNs to the ARTG entry for any medicines. Sponsors can of course still use a HCN as a quality marker as part of th