The Herbal Medicinal Product Committee (HMPC) has the exclusive authority at European level to independently assess the registration of herbal medicines. It started its work in 2004 on the basis of the EC Directive 2004/24/EC as a committee of the EMEA (European Agency for the Evaluation of Medicinal Products = European drug approval body) and decides on the classification of an herbal drug in the categories of "well-established medicinal use" and "traditional use". The findings are published like those of the Commission E and ESCOP in the form of drug monographs. The result states whether an herbal medicine is approved regularly for a particular area of use, or whether it can go through the easier registration process as a traditional medicine. The German regulatory authority (BfArM) takes over these findings and correspondingly transfers them within the framework of European harmonisation in order accordingly.
Before 2004, the BfArM, as part of the renewed authorisation according to ¤ 109a of the 5th AMG amendment 1994 and at the request of the manufacturer, carried out an evaluation of the drugs in terms of self-administered traditional use and then specified the traditional areas of use for the respective drugs in a list and published it in the Federal Gazette. The traditional herbal medicines registered for the German market during the period 1994 to 2005 (¤ 109a) now have to be reassessed acc. to ¤ 39a AMG.