Phytotherapy at an European Level

Abstract: The German Medicines Act (AMG) and the Council Directive 65165 EEC apply fully to herbal medicinal products. This was confirmed by the European Court of justice in 1992. A marketing authorisation according to Article 4 of Council Directive 65165 EEC, granted by the competent authority is obligatory if herbal remedies are sold as finished medicinal products. The applicant has to document quality, safety, and efficacy of his product. Herbal drugs are included in the German Pharmacopoeia DAB 96 and in the European Pharmacopoeia. Specific aspects of quality control of herbal remedies are described in the EE C note for guidance » Quality of herbal remedies,< and, on a national level, in the Guidelines for the Testing of Drugs following Article 26 AMG. The criteria for the evaluation of safety and efficacy apply to herbal remedies in the same way as they apply to other medicinal products with comparable indications. However, the complex composition of herbal active ingredients has to be taken into account. Because herbal remedies can rely on a long term use and experience, bibliographic data can be used in the assessment according to Article 4 No. 8a) ii) of Council Directive 65165 EEC. On a national level a definition of bibliographic data is set out in Article 22 (3) AMG and in the 5th section of the Guidelines for the Testing of drugs following Art. 2 6 AMG. The review of old medicinal products on the German market has resulted in monographs on active ingredients of herbal origin providing a positive or negative assessment on the safety and efficacy of these compounds. Herbal remedies with a »traditionally used" labelling do not comply with the E U criteria. For this reason they are only acceptable on national markets and with strictly limited indications and a special labelling.

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