Commission D

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The Commission D is an independent committee of experts at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany . She advises the BfArM in certain cases on the approval of homeopathic medicinal products for human medicine, in particular on questions relating to the use of homeopathic medicinal products in children and adolescents.

Mission and history

Commission D was established in 1978 at the Federal Health Office (BGA) responsible at the time , after the new Medicines Act (AMG) came into force . Purpose was, as part of the re-licensing the knowledge material to the homeopathic active ingredients used to evaluate the Altarzneimittelmarktes and lay down the result in monographs. The reauthorisation should be processed on this basis. Two further commissions were set up for herbal and anthroposophic medicinal products ( Commission E , Commission C). At that time, the three commissions published a total of around 2,350 monographs. In 1994, with the fifth amendment to the AMG, processing was discontinued. The positive monographs of Commission D continue to serve as the basis for the new approval of homeopathic medicinal products. Nowadays, Commission D still has to be heard on certain approval decisions, for example when corresponding preparations are subject to a prescription due to new active ingredients or new indications for known substances . Since the amendment to the Medicines Act in 2004, among other things, to improve the safety of medicines for children and young people, Commission D has also advised the authority on questions relating to the use of homeopathic medicines in this group of patients. The legal basis for the establishment of the commission is § 25 AMG . The interdisciplinary committee D consists of expert representatives from the fields of toxicology / pharmacology , medical statistics , pharmacy and application (doctors, mostly with the additional designation “homeopathy”, alternative practitioners ) and patient representatives . The members of Committee D are reappointed every three years.

Web links

literature

The information in this article comes from the following sources:

  • Hermann PT Ammon, Manfred Schubert-Zsilavecz [Hrsg.]: Hunnius Pharmaceutical Dictionary. 11th, updated edition, de Gruyter, Berlin, Boston 2014. ISBN 978-3-11-030990-4 . P. 1004.
  • H. Blasius: Special Drug Groups , Deutsche Apothekerzeitung, 2015, No. 11, p. 42.