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.

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.

The Terms of Reference (TOR) and its 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 OMCLs

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 planned market surveillance studies a risk based approach in choice of products has become common practice in OMCLs of the Network. Risk-based selection of samples and the importance of involving OMCLs in these planning activities are detailed in the position paper “Incorporation of a risk based approach in Market surveillance testing of OMCLs”.

For more information, click on the relevant link below.

additional information