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14/02/2022

Quality control of medicinal products and falsification

Each year, within its laboratory, the Market Surveillance and Pharmacovigilance Unit of the ANMV controls a series of veterinary medicinal products marketed in France.

The selection of medicinal products included in the laboratory’s annual programme is based on a risk analysis. This is based on the model for listing medicinal products initiated at European level. This programming also takes into account the follow-up of previously detected non-compliances, quality defects in previous years and requests from other departments of the Agency. 

These checks make it possible to verify compliance with the specifications declared in the marketing authorisation. 

Difficulties in the use of medicinal products observed in the field (solubility, re-suspension, etc.) may also be tested under a laboratory condition. 

The laboratory shall have the analytical capacity to confirm possible falsifications of veterinary medicinal products. 

Controlled medicinal products may have national or European marketing authorisations. In the case of European marketing authorisations, the programmes are coordinated by the Council of Europe’s European Directorate for the Quality of Medicines and Health Care. EDQM is responsible for the European Pharmacopoeia, which is the benchmark for the quality of medicinal products, whether for human or veterinary use. It also coordinates the network of Official Medicines Control Laboratories (OMCL). The ANMV laboratory, within the USMP, is recognised as a full member of this network. This status is maintained through regular peer recognition audits (or, failing this, through national accreditation audits) of the quality management system according to ISO 17025.

To access the thematic file

If you have any questions about the quality control of medicinal products, you can contact the Agency’s laboratory at the following address : ucqm@anses.fr