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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 08/04/2020

Quality control of veterinary medicinal products

Each year, within its laboratory, the ANMV's Market Surveillance Unit verifies a series of veterinary medicinal products marketed in France.

Veterinay medicinal products are selected for the annual laboratory programme according to the results of a risk analysis. This is based on the drug rating model developed at European level. This planning also takes into account the follow-up of any previously detected non-compliances, drugs that were the subject of quality defects in previous years, or requests from other Agency departments (Market Authorisations Department, Pharmacovigilance, etc.).

These checks serve to verify compliance with the specifications defined in the Marketing Authorisation.

Any difficulties in use of medicinal products observed in the field (solubility, re-suspension, etc.) can also be tested in laboratory conditions.

In addition, the laboratory has developed an analytical method to guide the detection of any falsified or counterfeit products.

The tested medicinal products may have national or European MAs. For European MAs, the programmes are coordinated at the level of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM: www.edqm.eu). The EDQM is responsible for the European Pharmacopoeia, the reference on medicinal product quality, whether for human or veterinary use. It also coordinates the network of Official Medicines Control Laboratories (OMCLs). The ANMV laboratory within the USM is recognised as a full member of this network (link to the list of OMCLs). This status is maintained through regular peer-review audits (or failing this, by national accreditation audits) of the Quality Management System according to the ISO 17025 standard.

The OMCLs exchange details of their annual testing programmes in order to avoid duplicate analyses: the results are shared and samples can also be sent between OMCLs.

To contact the laboratory: ucqm@anses.fr