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French Agency for Veterinary Medicinal Products

The French Agency for Veterinary Medicinal Products (ANMV) comes under the authority of the Director General of ANSES and carries out the missions assigned to the latter in the field of veterinary pharmacy.
For this purpose it is empowered to make scientific evaluations, carry out inspections and publish decisions. Among other tasks, it is responsible for authorisations concerning veterinary medicinal products. It organises the inspection of veterinary pharmaceutical companies and the pharmacovigilance system. It also carries out surveillance and monitoring activities concerning the quality of medicinal products.

In order to carry out its missions, the ANMV, the veterinary arm of ANSES, works closely with the French Commission for Veterinary Medicinal Products, for which it acts as administrative and scientific secretariat. The Commission is appointed by Order of the Ministries for Health and Agriculture.

Assessment

In cooperation with the French Commission for Veterinary Medicinal Products, the ANMV assesses:

  • marketing authorisation applications for all veterinary medicinal products (chemical drugs, pre-mixed drugs, vaccines and immunological medicinal products, products resulting from biotechnologies, etc.),
  • applications for registering homeopathic veterinary medicinal products,
  • applications for provisional authorisation for the use of veterinary medicinal products when requested by the Director General,
  • information on undesirable or unexpected effects, in animals and humans, of veterinary medicinal products.

More generally, it is responsible for issuing opinions on scientific issues relating to the assessment and marketing of veterinary medicinal products, and for recommending to the Director General of ANSES all studies and surveys it deems necessary for the assessment of veterinary medicinal products and the implementation of veterinary pharmacovigilance.

The ANMV also assesses European dossiers on the Maximum Residue Limits for veterinary medicinal products that are acceptable in foodstuffs of animal origin.

Marketing Authorisations

ANSES relies on the ANMV to assess applications for marketing veterinary medicinal products and the clinical trials related to them, and to provide authorisations.
The ANMV grants pharmaceutical companies authorisations to produce, sell and carry out wholesale distribution of veterinary medicinal products. It also grants import authorisations and export certificates for veterinary medicinal products (authorisations for specific products and for import and export companies).

Pharmacovigilance and surveillance

Veterinary pharmacovigilance involves monitoring for the emergence of undesirable or unexpected effects, attributable to the use of veterinary medicinal products, in light of studies carried out prior to the granting of marketing authorisation. The ANMV, supported by the French Commission for Veterinary Medicinal Products, carries out specific missions in this field: it studies the data sent to the Agency and issues opinions on the measures to be taken to prevent further incidents and accidents related to the use of a veterinary medicinal product, the simultaneous use of several veterinary medicinal products or the use in animals of medicinal products intended for humans.
Once the assessment is complete, it takes the necessary administrative measures to restrict the use or sale of these medicinal products.
The ANMV gathers information on the efficacy of medicines and their impact on the environment, as well as the validity of their withdrawal period (1). It takes into account uses that do not comply with the recommendations and labelling.
It carries out surveillance and analytical inspection missions regarding the quality of medicinal products and verifies the way they are advertised.

It organises the inspection of veterinary pharmaceutical companies and also carries out its own inspections.

International activities

The ANMV is represented on several European and international bodies, participating in discussions concerning veterinary pharmacy and contributing to the drafting of numerous regulatory and technical documents in this field. It is a World Organisation for Animal Health (OIE) collaborating centre for veterinary medicine.

• Participation at European level

  • European Medicines Agency (EMA): Committee for Medicinal Products for Veterinary Use (CVMP), Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv)
  • Heads of Medicines Agencies (HMA)
  • European Pharmacopoeia
  • European Directorate for the Quality of Medicines & Health Care (EDQM)
  • European Network of Official Medicines Control Laboratories (OMCLs)

• Participation at international level

  • Food and Agriculture Organization of the United Nations (FAO)
  • World Organisation for Animal Health (OIE)
  • World Health Organization (WHO)
  • Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF)
  • Veterinary International Conference on Harmonization (VICH)

Quality assurance

The ANMV has launched a programme for all its activities to be covered by quality assurance procedures. The Quality Control for Medicinal Products Unit and the Inspection Unit are accredited by COFRAC.

The Director of the ANMV is appointed by an Order issued jointly by the Ministers for Agriculture and Health at the proposal of the Director General. He acts as administrative head of the ANMV under the terms of Decree no. 82-453 of 28 May 1982 amended relative to hygiene and safety in the workplace as well as preventive medicine in the French civil service.
The ANMV is located at Javené, near Fougères, Brittany. It has a staff of 80.

Director: Jean-Pierre Orand
Deputy Director: Laurence Delva

(1) Minimum period between the administration of a medicinal product and the marketing of foodstuffs of animal origin (to ensure that foodstuffs do not contain drug residues capable of harming consumer health).

Find out more

 

National Commission on Veterinary Medicinal Products