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General European OMCL Network
Background
The Commission of the European Union (EU) and the Council of Europe decided on 26 May 1994 to create a network of official medicines control laboratories (OMCLs). This network amounted to a new collaboration in the area of quality control of marketed medicinal products for human and veterinary use. In 1995, the EDQM took upon itself this new responsibility and subsequently set it up. The activities of the network are partially financed by the European Commission. Click on the link for further information about the Role of the EDQM.
Collaboration within this network saves public money thanks to resource pooling. For the competent national authorities, it shares, thus avoids duplication of, work. Furthermore, they can access state-of-the-art technology and selective analytical procedures. Further information can be found under The Network's Mission.
The Terms of Reference (TOR) and its three annexes define the rules and roles of the Network and its members. They specify the duties and benefits arising from membership. Annex 3 includes a list of all current full and associated members. It is a living document and is updated as new members, fulfilling all criteria as defined in the TOR, join. These documents can be downloaded via the right-hand menu.
About Official Medicines Control Laboratories (OMCLs)
Official Medicines Control Laboratories (OMCLs) support regulatory authorities in controlling the quality of medicinal products for human and veterinary use available on the market. Independently from manufacturers, thus without any conflict of interest, OMCLs test these products, depending on the activity, in either:
- Member and Observer States of the Convention on the Elaboration of a European Pharmacopoeia involved in the general activities of the network; or
- Member States of the European Union (EU) and the European Economic Area (EEA) and Switzerland where appropriate.
For more information, click on the relevant link below.
Levels of collaboration
Additional Information & Documentation
- UPDATED: Annex 3 to the GEON Terms of Reference: List of GEON Members (PA/PH/OMCL (09) 45 7R)
- Letter EDQM & HMA on HMA Working Group on Product Testing Document
- Principles for Mutual Recognition of Control Results (Version 1.0)
Further information can be found in the Download section.
Related Links
European Commission - Directorate General Health & Consumer Protection - Public Health
European Medicines Agency (EMA)
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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