LEGAL REQUIREMENTS FOR THE USE OF PHYTOPHARMACEUTICAL DRUGS IN THE FEDERAL-REPUBLIC-OF-GERMANY

The legal status for herbal remedies is defined by the Drug Law of 24 August 1976 in the version of the forth law amending of April 1990. For finished drug a marketing authorization is obligatory. Herbal finished rugs hae to comply with the same criteria for quality, safety and efficacy as all other finished drugs. Marketing of finished herbal drugs is possible by three ways: 1. Procedure of evaluation and validation of old medicines. Finished drugs registered in 1978 did possess a provisional marketing authorization and could be on the market until the end of April 1990. The medical evaluation of these drugs is mainly based on bibliographic data and it is done by a special expert committee, the Commission E. It is documented by a monograph which is the basis for the assessment of these drugs starting this year. 2. Standardized marketing authorization. Medicines which do not represent a direct or indirect risk for health can be exempted from the need of an individual marketing authorization by monographs of standardized marketing authorizations. If a applicant refers to such a monograph he does not have to present any documentation. 3. Individual applications for marketing authorization. In this procedure a complete documentation including the results of analytical tests, results of the pharmacological and toxicological tests and results of clinical or other medical tests are required. Drugs sold outside pharmacies and referring only to traditional uses without clinical evidence for efficacy have to be labelled as "traditionally used".