Regulatory affairs of Homeopathic Medicinal Products in Europe (HMPs)
Dr. Reinhard Länger
Head of Dept. for herbal, homeopathic & veterinary medicinal products
Austrian Medicines and Medical Devices Agency (AGES MEA)
Licensed homoeopathic medicinal products have to be approved by National Medicines Agencies prior to marketing. The legislative framework is defined in Dir. 2001/83/EC as amended. However, additional national provisions may apply as set out for example in the national Austrian medicines law. The documentation which is required regarding quality, safety and efficacy as well as the different procedures for marketing authorisation or registration are presented and discussed.
Dr. Länger is a pharmacist, he worked from 1982 on as Assistant Professor at the Dept. of Pharmacognosy, Univ. of Vienna, followed by the position of Assoc. Prof. at the Dept. of Pharmacognosy, Univ. of Vienna from 1997. Since 2006 he is Assessor at the Austrian Medicines and Medical Devices Agency.
Austrian delegate to the Committee for Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA)
Member of the Monographs and Lists Working Party (MLWP) of the HMPC
Specialist in the working group on Traditional Chinese Medicines (TCM) at the European Directorate for the Quality of Medicines (EDQM)
Specialist in the working group on Herbal Extracts at the EDQM
Specialist in the working group on the Microbiological Quality of Herbal MedicinalProducts at the EDQM
Member of the national pharmacopoeia commission and expert group