Herbal Medicinal Products in Germany and Europe: Experiences with National and European Assessment

Abstract

The German Medicines Act (AMG) and the Council Directive 65/65 European Economic Community (EEC) apply fully to herbal medicinal products. This was confirmed by the European Court of Justice in 1992. A marketing authorization according to Article 4 of Council Directive 65/65 EEC granted by the competent authority is obligatory if herbal remedies are sold as finished medicinal products. The applicant must document quality, safety, and efficacy of its product. The term “herbal remedies” includes medicinal products containing exclusively plant material or vegetable drug preparations as active ingredients. Homoeopathic preparations or isolated constituents such as Menthol or Digitoxin are not considered herbal remedies. 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 EEC 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. The complex composition of herbal active ingredients, however, must be taken into account. Because herbal remedies can rely on long-term use and experience, bibliographic data can be used in the assessment according to Article 4 No. 8 a, ii of Council Directive 65/65 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. 26 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 a negative assessment of the safety and efficacy of these compounds. Herbal remedies with “traditionally used” labeling do not comply with the European Union (EU) criteria. For this reason they are only acceptable on national markets and with strictly limited indications and special labeling.