Existing authorisations for Echinacea products in the UK

This is a draft paper for discussion. It does not reflect the views of the Committee and should not be cited.

11.             Herbal products containing E. purpurea (L.) Moench. (European Medicines Agency (EMA) 2014), E. angustifolia DC, radix (EMA 2012) and E. pallida (Nutt.) Nutt., radix have herbal medicinal licences in EU/EEA member states. In the UK, there are a range of Echinacea products holding a Traditional Herbal Registration (THR) from the MHRA under the THR scheme (for the list of products see Table 13 Appendix B). These products have been approved for the relief of the common cold symptoms and influenza type infections, symptomatic relief of minor skin conditions such as spots, pimples, and blemishes and relief of minor urinary complaints associated with cystitis in women based on traditional use only in adults and children over 12 years for a maximum duration of 10 days. None of these products are recommended for pregnant or lactating women. Although Echinacea dietary supplements are the focus of this paper, the products holding a THR are worth noting for reference to doses and preparations (for further information on doses and preparations of THR Echinacea products and EMA monographs please see Table 14 Appendix B). It should be noted, however, that food supplements may differ significantly from EMA or MHRA approved herbal medicinal preparations in terms of preparation, composition, quality, and manufacturing standards. Therefore, it may not be appropriate to directly read across findings from studies or monographs on licensed products to food supplements.

12.             A Traditional Herbal Registration (THR) can only be granted by the MHRA following a formal application that meets all the required standards for quality, safety, evidence of traditional use, and other criteria as set out in the Human Medicines Regulations 2012 (HMR, 2012). The evidence of traditional use relates to the product having been in traditional medicinal use for a continuous period of at least 30 years, of which at least 15 years must be within the European Union (Part 7 HMR, 2012). The safety requirements are a bibliographic review of safety data together with an expert report on safety (Schedule 12, HMR, 2012).