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Quality control of medicines

Control analysis of medicines forms part of the state supervision exercised by the State Agency of Medicines. The aim is to make sure that the medicines used in Estonia meet the applicable quality requirements and thereby contribute to ensuring the efficacy and safety. Although pharmaceutical companies check the quality of each batch before release, risk-based tests of marketed medicines are carried out in the Laboratory of the State Agency of Medicines.

The Laboratory has an ongoing market surveillance plan under which are analysed authorised and unauthorised medicines, medicines prepared in pharmacies, active ingredients and excipients used in the manufacture of medicines. The medicines to be analysed are selected in cooperation with other departments of the Agency, taking into account the extent of the risk arising from possible quality problems (wide use, relatively instable active ingredients, similar preparations from different manufacturers etc.). Samples are usually taken at wholesale or pharmacy levels, and occasionally also from the marketing authorisation holders.

Quality control of medicines also involves international cooperation. The Laboratory is a member of the OMCL (Network of Official Medicines Control Laboratories), coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM), which ensures international recognition of analytical results. The Laboratory is accredited by the Estonian Accreditation Centre for analyses of medicines (registration number L 217).

Last updated: 06.04.2023