Importance of HMPC community monographs and community list entries for the marketing authorisation and registration of herbal medicinal products in Europe

Recently the HMPC Working Party on Community Monographs and Community List (MLWP) finalised the procedures and templates for the preparation of an entry to the Community List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (EMEA/HMPC/57137/2007), and released the document for the three-month public consultation. By now, about ten community herbal monographs and/or list entries have been adopted for publication and twenty more are in several phases according to the timetable viz. between drafting to release for public consultation and from public consultation to finalisation by the MLWP. It is therefore appropriate in this workshop to discuss the implementation of these documents at the level of the national authorities and the manufacturers of herbal medicinal products, especially in terms of legal basis, rational and feasibility. More specifically, will these documents not only represent current scientific knowledge, but might they also serve as guidance on harmonized criteria for the evaluation of herbal medicinal products in Europe? Moreover, will these documents not only allow to discriminate between well-established and traditional use for herbal medicinal products but also between traditional herbal medicinal products and herbals containing food supplements throughout Europe?

It is expected to gain critical feedback from all participants in terms of harmonisation across the EU, so that more successful applications on herbal medicinal products to the regulatory authorities would be submitted in the future.