Quality control of authorised veterinary medicinal products is carried out by the ANMV laboratory. Every year, a control programme is drawn up based on a risk analysis. Medicinal products on the market are taken from wholesalers and analysed to ensure that they comply with the specifications validated in the MA. Leaflets and labels for authorised medicinal products, as well as updates, are also checked.
Reported quality defects are managed and monitored by means of a risk analysis, which may lead to batch recalls at the various stages of the distribution chain.
Stock shortages of veterinary medicinal products are reported to the Agency by manufacturers for a joint assessment of their criticality, monitoring and the identification of possible alternatives.
Advertisements for veterinary medicinal products must be systematically submitted to the ANMV and some of them may be subject to prior authorisation.
Legal classification of "borderline" products on the market serves to identify whether products fall within the scope of veterinary medicinal product regulations or other regulations such as those on biocides, animal feed, etc.
Work on the mapping of therapeutic gaps by animal species is continuing, with the organisation of meetings by sector to monitor developments. The aim is to seek therapeutic solutions to resolve these gaps by working with all stakeholders within the French animal health network (RFSA).
Each year, ANMV publishes an annual overall report on surveillance of the veterinary medicinal product market in France (see annual report 2018), and presents the results obtained from inspection of veterinary pharmaceutical establishments, pharmacovigilance and market surveillance.
The surveillance system for veterinary medicinal products developed in recent years by ANMV ensures that the veterinary medicinal products placed on the French market meet criteria relating to quality, safety and effectiveness. In this respect, the detection tools and systems developed have now proved their worth.
However, these tools can only function with the active participation of all the players in the veterinary medicinal product chain, and require the mobilisation and contribution of all.
To contact the Market Surveillance unit: firstname.lastname@example.org
Contents - Market surveillance
• Quality control of veterinary medicinal products
• Quality defects
• Batch recalls
• Stock shortages
• Legal classification of "borderline" products
ANSES-ANMV is responsible for controlling the advertising of veterinary medicinal products. For this reason, all advertising documents must be submitted to the Agency, and some even require authorisation, before being distributed.
The French Agency for Veterinary Medicinal Products (ANSES-ANMV) is regularly called upon to qualify the legal status of products with regard to French and EU regulations and to determine whether these products, their placing on the market, their production and distribution fall within the scope of the regulations on veterinary medicinal products. To do this, ANSES-ANMV relies on the definition of a veterinary medicinal product according to European Directive 2001/82/EC as amended, which has been transposed into Articles L. 5111-1 and L. 5141-1 of the Public Health Code.
A batch recall is considered following identification of a quality defect or pharmacovigilance problem, or following a decision to suspend/revoke a marketing authorisation or temporary authorisation for use.
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