Background

The European Commission (EC) directive on traditional herbal medicines (2004/24/EC) passed into law in 2004.  The directive allows a 7-year transition phase during which time companies manufacturing or distributing herbal medicines derived from long-standing cultures are expected to submit dossiers for individual products.  Dossiers should be submitted to the relevant competent authorities in any of the 27 member states of the European Union (EU) and following centralised approval by a committee in the European Medicines Agency (EMEA), the product may be sold EU-wide.
 
To-date, not a single herbal product from the Traditional Chinese Medicine (TCM) tradition or that of the other great holistic healthcare traditions, e.g. Ayurveda, have been registered.  Given that in many member states the food supplement regime for botanical containing food supplements will alter following the end of the transition phase, 31st March 2011, it is expected — should the directive not be amended — that a great many Chinese and other herbal medicines will become unavailable in Europe.  One of the principal reasons for lack of registrations under the simplified medicinal licensing regime offered by the directive, are the technical difficulties involved in preparing dossiers.  An explanation of these difficulties are given in a separate report in these proceedings by Dr R Verkerk of the Alliance for Natural Health International (ANH-Intl).
 
This report will consider a multi-faceted strategy which could be implemented to safeguard the long-term future of TCM, as well as other traditional medicinal systems, in Europe.