Why an OMCL Network?

What is an Official Medicines Control Laboratory (OMCL)?

OMCLs are official laboratories who support regulatory authorities and complement the inspection services in controlling the quality of medicinal products on the market by independent testing.  It is an independent laboratory responsible for the quality control of medicines for human and veterinary use in

• Member States of the Convention on the Elaboration of a European Pharmacopoeia and the observer states, which are involved in the general activities of the network. All the OMCLs are invited to participate in meetings and in collaborative studies in all the areas of general interest.

• Member States restricted to the European Union and the European Economic Area (EEA). A number of activities take place within the more restrictive regulatory framework for medicines in the European Union, notably those connected to the centralised Community authorisation procedures and to batch release of biologicals).
  

They are nominated by each national authority in charge of the quality control of medicines in European countries.  Other non-European countries can participate but only as observer in the work programme of the network. Their participation is discussed and either accepted or rejected during the annual seminar of the network.

When and why was the Network set-up?

The Commission of the European Communities (EU) and the Council of Europe decided on 26 May 1994 to create the European Network of OMCLs and to start a new collaboration in the area of the quality control of marketed medicines.  The European Pharmacopoeia Secretariat took on this new responsibilities and set up the European network of laboratories involved in the quality control of medicines for human and veterinary use.

Why was the decision taken?

The construction of the European regulatory system was finalised in 1993 by adopting a regulation and two Directives (Council regulation (EEC) No 2309/93 and Council Directives 93/39/EEC and 93/40/EEC, respectively) which lead to the setting up of a European Agency for the Evaluation of Medicinal Products (EMEA) and established community procedures for licensing and surveillance of medicinal products for human and veterinary use:

• on the one hand, a centralised procedure for biotechnology-derived products or any technologically advanced medicinal product, and
  
• on the other hand, a decentralised procedure which applies to most conventional pharmaceutical products.

This procedure is based on the extension of national marketing authorisations to one or more additional member states according to the principle of mutual recognition. These new regulations on medicines laid down by the European Union and the granting of marketing authorisations that are valid throughout the community have considerably increased the free movement of medicines, which makes it even more important to reconsider the methods for analytical supervision previously carried out individually by each national authority and to set up a co-ordinated European approach for surveillance of marketed products.

The missions of the European network of OMCLs

Its main goals are mutual recognition of tests carried out at the national level for countries that belong to the European Union, and sharing of expertise, standardisation, and international collaboration for the other countries.
In particular, the co-operation programme is aimed at:

• improving communications (establishing a network of European laboratories and its handbook, data base and newsletters);
• co-ordinate the activities of the OMCLs;
  
• harmonising methods of work, setting up a harmonised European quality system, including an intensive programme of proficiency tests,
  
• exchanging information on work programmes to optimise the use of expertise and laboratory resources, as well as available analytical data, organising collaborative studies (on the validation of methods),
  
• facilitate exchanges of know-how, and
  
• promote the future development of harmonised common standards.