title: [The network of official medicines control laboratories].
abstract: Licensing, control and surveillance by competent authorities is the basis for ensuring efficacy, safety and quality of medicines in Europe. The control of the quality of medicines by national control laboratories, known as Official Medicines Control Laboratories (OMCLs) is an essential step in this process; it encompasses controls before and after granting a marketing authorisation. For certain groups of biomedical medicines (vaccines for human and veterinary use, medicines derived from human plasma) even each batch is controlled before it can be placed on the market. As single OMCLs would not be able to cope with their task, given the large number and diversity of medicines, in 1994 the OMCL network was founded upon initiative of the European Directorate for the Quality of Medicines & HealthCare, in close collaboration with the Commission of the European Union. Currently 68 OMCLs from 39 countries are part of the network. Prerequisite for the smooth operation of the OMCL network is the harmonisation of the quality management system of the individual OMCLs, based on the ISO 17025 standard, internal guidelines and the European Pharmacopoeia. Compliance with these standards is checked through regular audits, thus creating the basis for mutual recognition of test results. The collaboration in the OMCL network for the surveillance of the medicines market, the official control authority batch release and the fight against counterfeiting and illegal medicines enables OMCLs to keep pace with the developments in the field of medicines and to control the broad spectrum of medicines. In the 20 years since its start, the OMCL network has become a European success story.
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Europarat, 7 allée Kastner, CS30026, 67081, Strasbourg, Frankreich, karl.buchheit@edqm.eu.
authors.forename: K-H
authors.initials: KH
authors.lastname: Buchheit
authors.forename: R
authors.initials: R
authors.lastname: Wanko
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D005858:Germany; D033161:Government Regulation; D007753:Laboratories / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug / Q000458:organization & administration; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D017751:Safety Management / Q000331:legislation & jurisprudence
chemical_list: D004364:Pharmaceutical Preparations