Official Medicines Control Laboratory

An Official Medicines Control Laboratory (OMCL) is an official laboratory for the investigation and independent quality control of medicinal products and other similarly regulated substances.

The OMCLs examine medicinal products as to whether they meet the conditions of content, purity, etc., as specified in the approval. It is also checked whether the labeling and the usage information are in accordance with the legal requirements. Investigations are also carried out on products suspected of being counterfeits. Another focus of the OMCLs is the product delimitation between medicines on the one hand and other products such as foodstuffs, cosmetics, medical devices, care products, etc., which is often only analytically possible.

In the United Kingdom, the OMCL is the National Institute for Biological Standards and Control.

In Germany, the regional authorities coordinate their work in the Central Office of the Länder for Health Protection of Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten; ZLG).

The European OMCLs are joined by the European Directorate for the Quality of Medicines (EDQM) in the so-called OMCL Network.

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