The French Agency for Veterinary Medicinal Products – Structure
The Organisational chart of the Agency (pdf) was established by a decision of the Director General (pdf, in French) and delegations of signature authorisations were set up in application of this organisational structure.
The Director of the French Agency for Veterinary Medicinal Products, Jean-Pierre Orand, was nominated through a Ministerial Order (pdf, in French) issued by the Minister of Health and Sport and the Minister of Food, Agriculture and Fisheries on 12 July 2010 (see Decision dated 9 September 2010 (pdf, in French) delegating the authority of the Director General of the French Agency for Food, Environmental and Occupational Health & Safety to the Director of the Agency for Veterinary Medicinal Products).
The activity report for the ANMV is published as part of ANSES’s annual report.
In the interests of transparency and impartiality, the public declarations of interests of all agents at the ANMV and of the experts on corresponding committees are accessible on the ANMV page of the ANSES website.
To fulfil its missions, the ANMV’s activities are organised into three departments:
Marketing Authorisations Department
The Department is made up of three units and is responsible for evaluating chemical and immunological veterinary medicinal products. It prepares the administrative decisions related to evaluation with a view to granting or denying Marketing Authorisations (MAs).
It represents France in the Coordination Group for Mutual Recognition & Decentralised Procedures - Veterinary (CMDv).
It evaluates and manages temporary authorisations for use, clinical trials, and import authorisations.
Its experts also participate in evaluation of dossiers concerning maximum residue limits.
The reviewers at the Agency are members of the main working groups of the Committee for Medicinal Products for Veterinary Use (CVMP).
This Department is tasked with coordinating and organising a national pharmacovigilance system for veterinary medicinal products, specifically by coordinating and following up the activities of the Veterinary Pharmacovigilance Centre in Lyon (CPVL).
In particular, the Department is responsible for:
- Managing the national veterinary pharmacovigilance database;
- Transferring veterinary pharmacovigilance cases from France to the centralised European database;
- Evaluating and transmitting adverse effect reports received by the department either from Marketing Authorisation Holders, private individuals or healthcare professionals (communicated electronically or by mail);
- Evaluating veterinary pharmacovigilance systems submitted as part of veterinary MA application dossiers;
- Evaluating Periodic Safety Update Reports submitted by MA Holders;
- Evaluating pharmacovigilance data in the context of benefit-risks assessments during MA renewal procedures;
- Implementing and monitoring of networks of referring veterinarians in pharmacovigilance.
Inspection and Market Surveillance Department
The Department is made up of three units and is responsible for:
- Examining and managing authorisation applications for establishments involved in the manufacture, marketing, import, wholesale distribution or export of veterinary medicinal products;
- Inspecting establishments;
- Testing or coordinating testing of veterinary medicinal products during the authorisation application procedure or after they have been placed on the market;
- Verifying compliance of labelling and package leaflets for veterinary medicinal products;
- Certifying compliance with good practices;
- Certifying veterinary medicinal products intended for export;
- Following up measures concerning quality defects for batches of veterinary medicinal products;
- Carrying out various cross-functional and support activities.
The ANMV also has several support functions:
The Agency is actively involved in the international arena both as the Competent Authority for France and as a Collaborating Centre for the World Organisation for Animal Health (OIE), which has 176 member countries and territories. In this capacity, the ANMV implements the OIE programme on veterinary medicinal products and provides the organisation with technical support for all questions regarding veterinary pharmacy. It is involved specifically in the following bodies:
- Veterinary International Conference on Harmonization (VICH);
- The West African Economic and Monetary Union (WAEMU);
- FAO and WHO.
Legal Affairs and Litigation
The Legal Affairs and Litigation Department is tasked with contributing to preparation of regulatory texts regarding veterinary pharmacy, ensuring internal and external legal consultations, and managing administrative and legal disputes.
The ANMV's management system is being ISO 9001 certified since September 2013 for the following activities:
Provision of a scientific expertise as regards veterinary medicines in compliance with the requirements of the NF X 50 110 standard, authorisation of veterinary medicines and veterinary pharmaceutical companies and inspection of veterinary medicines placed on the market. Provision of expertise and development assistance as regards veterinary medicines governance.
The Agency is also involved in benchmarking activities which apply to all competent European authorities for medicinal products for human and/or veterinary use.
As a member of the European network of Official Medicines Control Laboratories (OMCLs), the medicinal product quality control unit participates in the Mutual Joint Audit organised by the European Directorate for the Quality of Medicines and HealthCare (EDQM). This recognition of the laboratory’s competence was renewed in December 2015 further to the results of this audit.
In 2008, an audit of its working procedures and quality management system (Joint Audit Program and Pharmaceutical Inspection Cooperation Scheme) was carried out by European reviewers in the inspection area. As of 1 Januaray 2009, the ANMV was found to comply with the requirements of both recognitions.