term “herbal remedies” includes Because herbal remedies can rely on long-term use and experience, bibliographic data Herbal remedies with “tradition …
Drug Information Journal, Vol 30, pp 933948, 1996 Printed in the USA All rights reserved
0092-8615/96 Copyright 1996 Drug Information Association Inc
HERBAL MEDICINAL PRODUCTS IN GERMANY AND EUROPE: EXPERIENCES WITH NATIONAL AND EUROPEAN ASSESSMENT
KONSTANTIN KELLER, PHD
Director and Professor, Federal Institute for Drugs and Medical Devices, Berlin, Germany
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
Read More »