The French Agency for Veterinary Medicinal Products – Organisation

Responsible for evaluating veterinary medicinal product dossiers submitted for authorisation, registration or declaration, and for scientific projects.

In particular:

• it carries out expert appraisals of authorisation applications (see the marketing authorisation procedures) as part of national, mutual recognition, decentralised and centralised procedures for all veterinary medicinal products;
• for centralised procedures, it carries out expert appraisals of dossiers on maximum residue limits for substances contained in medicinal products intended for food-producing species;
• for requests (formal requests, questions from the supervisory authorities, stakeholders, internal questions) falling within the remit of the Scientific Assessment Department, it plans and leads work and, where appropriate, sets up and coordinates working groups. It also contributes to the drafting of responses (notes, opinions, reports) and related documents.

The Scientific Assessment Department consists of: 

• the Scientific Expertise Unit, responsible for assessing:
  • applications for authorisation of veterinary medicinal products;
  • maximum residue limits;
  • scientific projects falling within the department's remit (formal requests, questions from the supervisory authorities stakeholders, internal questions).
• the Coordination Unit, responsible for:
  • rapporteur work on dossiers;
  • supervising procedures;
  • planning and leading work on scientific projects within the department's remit (formal requests, questions from the supervisory authorities, stakeholders, internal questions);
  • coordinating and leading a project focused on innovative therapies.

 Responsible for dossier admissibility and administrative examination, preparation and follow-up of decisions on veterinary medicinal products and pharmaceutical establishments, and certification.

In particular:

• it manages and examines applications for authorisation and registration of veterinary medicinal products;
• it manages and examines applications for authorisation for establishments engaged in the manufacture, exploitation, import; wholesale distribution and export of veterinary medicinal products, and those engaged in the preparation of autogenous vaccines;
• it certifies compliance with good practice (GMP, GLP) for veterinary pharmaceutical establishments and testing facilities;
• it examines notifications of clinical trials;
• it certifies veterinary medicinal products intended for export;
• it authorises the official release of immunological products.

Responsible for monitoring and verifying compliance of veterinary medicinal products on the market, pharmacovigilance, as well as inspecting pharmaceutical establishments, test facilities and entities preparing autogenous vaccines.

In particular:

• it inspects and monitors establishments engaged in the manufacture, exploitation, import, wholesale distribution and export of veterinary medicinal products, and those engaged in the preparation of autogenous vaccines. It also inspects facilities in accordance with good practice applicable to the activity;
• it conducts market surveillance and verifies compliance of veterinary medicinal products;
• it leads and coordinates the national veterinary pharmacovigilance scheme;
• it monitors the benefit/risk ratio of veterinary medicines.

The Inspection, Surveillance and Pharmacovigilance Department consists of: 

• the Inspection Unit, which is tasked with inspections and investigations of establishments, test facilities and products;
• the Market Surveillance and Pharmacovigilance Unit, which is responsible for information, health monitoring, pharmaceutical monitoring and verifying compliance of veterinary medicinal products, as well as coordinating the national veterinary pharmacovigilance scheme (which includes guiding and monitoring the activities of the veterinary pharmacovigilance centre in Lyon manage by Vetagrosup.

 Responsible for:

• carrying out missions and supervising actions falling within the international scope of the ANMV as a French agency and WOAH collaborating centre. It also undertakes bilateral and multilateral activities for technical cooperation (technical and financial aspects);
• coordinating the European health policy for veterinary medicinal products within the ANMV.
   

Responsible for:

• ensuring legal watch and providing regulatory support to ANMV in the area of veterinary pharmacy;
• drafting projects, coordinating consultations on regulatory texts or bills falling within the remit of the Director General of Anses (decisions) or issued following a proposal by the Director General (orders) in the area of veterinary medicinal products;
• participating in the drafting of briefs on French and EU litigation concerning veterinary medicinal products in conjunction with the Legal Affairs Department of Anses;
• coordinating the work of the Monitoring Committee for Veterinary Medicinal Products; 
• leading work on cross-cutting issues at the ANMV by setting up working groups with the specialist departments, where necessary, and drafting responses (notes, opinions, reports) and related documents.

Responsible for:

• ensuring the collection of data on sales of antimicrobials in veterinary medicine;
• analysing the data collected and assessing the use of antimicrobials in the various animal species;
• helping to assess the risk of emergence of antimicrobial resistance phenomena from application dossiers relating to the marketing of veterinary medicinal products, and to assess alternatives to antimicrobials;
• contributing to national, European and international work in the area of antimicrobial resistance;
• participating as a collaborating centre in the WOAH's work in the area of antimicrobial resistance.

See the presentation on antimicrobial resistance.