Official Medicines Control Laboratory

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An official drug testing agency, engl. Official Medicines Control Laboratory (OMCL) is an official testing laboratory for the investigation and independent quality control of drugs and other substances subject to drug monitoring .

The legal basis for the work of the OMCLs in Germany is Section 65 of the German Medicines Act (AMG). According to this, samples are to be taken and officially examined as part of the monitoring of drug traffic. Appropriate compensation must be paid by the pharmaceutical entrepreneur (marketing authorization holder) to the point at which the samples are taken (e.g. pharmacy , wholesaler) .

The OMCLs examine the medicinal products to determine whether they meet the conditions for content, purity etc. specified in the approval . It is also checked whether the labeling and the instructions for use comply with the legal requirements. Products that are suspected of being counterfeit drugs are also examined. Another focus of the OMCLs is the product differentiation between pharmaceuticals on the one hand and other products such as food, cosmetics, medical products , care products, etc. on the other, which is often only possible analytically.

In Germany, drug monitoring and thus also the investigation is a matter for the federal states. The state authorities coordinate their work in the central office of the states for health protection for drugs and medical devices (ZLG).

The European OMCLs are part of the European Directorate for the Quality of Medicines (EDQM) in the so-called OMCL network .

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