OMCL - Background and mission

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.

Role of the EDQM

The EDQM is the Network's secretariat, responsible for co-ordinating the structural network activities and for the smooth organisation of the different joint programmes.

Work programmes are decided on an annual basis in collaboration with the National Authorities and, where applicable, the European Medicines Agency (EMA).

The OMCL Network's Mission

Its main goals are as follows:

mutual recognition, within the European Union, of tests carried out by Official Medicines Control Laboratories (OMCLs) at the national level;
improve communication among the OMCLs via a network, handbooks, and suitable Information Technology (IT) tools (e.g. databases);
coordinate activities among the OMCLs;
harmonise working methods within the Network by implementing and maintaining a quality management system referring to a commonly agreed standard, which includes an intensive proficiency testing programme and assessment of the system by peers' audits;
exchange information on work programmes to optimise the use of expertise, laboratory resources and analytical data available;
organise collaborative studies on the validation of methods;
facilitate knowledge and work sharing;
promote the future development of harmonised standards;
collaborate with relevant institutions within and beyond Europe; and
contribute to the establishment of reference substances and preparations.

About OMCLsNetwork of 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 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”.

Levels of collaboration

There are two levels of collaboration within the network.

Firstly, general activities are open to all the member and observer states of the European Convention on the Elaboration of a European Pharmacopoeia. These activities are as follows:

the Quality Assurance (QA) Programme;
the Proficiency Testing Scheme (PTS) studies;
the general Market Surveillance Scheme (MSS);
educational activities; and
applied analytical research and standardisation development.

Secondly, certain activities involve countries from the European Union (EU) and the European Economic Area (EEA) only. These are as follows:

the Centrally Authorised Products (CAP) Sampling & Testing Programme;
the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP) Post Marketing Surveillance Scheme; and
the Official Control Authority Batch Release (OCABR) for human biological medicinal products, and OCABR and Official Batch Protocol Review (OBPR) for immunological veterinary medicinal products (IVMPs).

Network membership

Within Europe, OMCLs are nominated by the national authority responsible for the quality control of medicines in their country. Regular meetings are held with members of the Network and collaborative studies are organised.

Laboratories from non-European countries can participate as associate members of the work programme.

For further information, contact us via the HelpDesk.

additional information

Terms of Reference for the GEON of the CoE: PA/PH/OMCL (07) 79 R39CORR
Annex 1 to the GEON Terms of Reference: Definition, role and status of OMCLs of the GEON (PA/PH/OMCL (07) 89 R15)
Annex 2 to the GEON Terms of Reference: Factors for determining OMCL status within the GEON (PA/PH/OMCL (07) 90 R12)
REVISED Annex 3 to the GEON Terms of Reference: List of GEON Members (PA/PH/OMCL (09) 45 R42)
Annex 4 to the GEON Terms of Reference: Questionnaire to query the OMCL status of present and future members of the GEON (PA/PH/OMCL (08) 04 R22)
Annex 5 to the GEON Terms of Reference: Maintenance of Membership to the GEON (PA/PH/OMCL (10) 93 R10)
Annex 6 to the GEON Terms of Reference: Application for new membership to the GEON (PA/PH/OMCL (09) 83 8R)
Annex 7 to the GEON Terms of Reference: Mutual Recognition of Test Results (PA/PH/OMCL (16) 49 R2)
Annex 8 to the GEON Terms of Reference: Policy in case of exceptional voting (PA/PH/OMCL (15) 99 R3)