We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Herbal component names
Herbal ingredients contain chemical constituents that can be used as therapeutic or quality markers. These constituents are referred to as "herbal components" and have previously been given a Herbal Component Name (HCN). In listed medicines, HCNs are not standalone active ingredients and must be used in conjunction with the parent herbal ingredient. 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 in the ARTG.
Outcome of the public consultation
A proposal to discontinue the receipt and pre-market evaluation of non-mandatory HCNs was the subject of a public consultation published on the TGA website on 17 November 2017. The outcome of the consultation has informed our position going forward. Although sponsors may still make label claims for herbal components, the name will no longer be determined by the TGA. Sponsors will not be able to submit new HCN applications effective immediately. After 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings unless they are mandatory. The TGA will continue to work with industry to discontinue pre-market evaluation of HCNs.
The Complementary and OTC Medicines Branch has prepared the following frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs. If you have a question relating to the discontinuation of this activity which is not captured below, please contact the Complementary and OTC Medicines Branch.
Contact details
- Email: nonprescriptionmedicines@health.gov.au
- Phone: 1800 020 653 (freecall within Australia)