Thanks to its expertise, ANSES-ANMV is an agency which is highly involved in European as well as international activities. It contributes actively to discussions on veterinary medicinal products and to the drafting of various regulatory and technical texts. It works as a collaborating centre for the World Organisation for Animal Health (OIE), and participates in work by the United Nations Food and Agriculture Organisation (FAO) and the World Health Organization (WHO).
Its international activity is one of the strategic priorities of ANSES-ANMV and is an integral part of its missions and procedures. In September 2013, it obtained recognition for its expertise and management in this area through ISO 9001 certification, with both national and international scope. It is certified to "provide international expert appraisal and developmental support in the area of veterinary medicinal product governance".
The World Organisation for Animal Health (OIE)
For more information on the OIE...
The OIE, created in 1924, is the intergovernmental organisation responsible for improving animal health worldwide.
The standards established by the Organisation are recognised as international benchmarks by the World Trade Organization (WTO) within the framework of the Sanitary and Phytosanitary (SPS) Agreement. In 2013 the OIE had a total of 178 Member Countries.
The Collaborating Centres
OIE Collaborating Centres are centres of expertise in a specific designated sphere of competence relating to the management of general questions on animal health issues ("specialty"). The French Agency for Veterinary Medicinal Products (ANSES-ANMV) has been a collaborating centre for veterinary drugs since 1992.
ANSES-ANMV, as an OIE collaborating centre, carries out actions regarding the following areas:
- Assistance in drafting procedures that facilitate harmonisation of regulations concerning animal diseases and international standards;
- Training activities;
- Help in the organisation of scientific meetings for the OIE;
- Participation in the OIE twinning process;
- Representing the OIE at VICH steering committee meetings and CCRVDF meetings.
International harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH)
For more information on VICH...
VICH is an international programme whose mission is to develop harmonised requirements for registration of veterinary medicinal products. The steering committee includes representatives from the relevant authorities and from the veterinary drug sector of the United States, Japan and the European Union. South Africa, Australia, Canada and New Zealand have steering committee observer status. ANSES-ANMV, as a collaborating centre for veterinary medicinal products, has participated actively in this work as an associate member in conjunction with the OIE since the founding of VICH in 1995.
VICH has decided to set up a “VICH outreach forum” bringing together both VICH and non-VICH countries, in order to take into account the expectations of the latter and to obtain wider international harmonisation with regard to the technical requirements for registration of veterinary medicinal products. Visit the "VICH Outreach Forum" website...
3rd VICH Outreach Forum Meeting (Auckland, NZ, November 12-13th 2013) – report (pdf)
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
For more information on PIC/S...
The main mission of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is to provide international leadership for the drafting of harmonised Good Manufacturing Practice (GMP) standards for medicinal products (as well as for pharmaceutical raw materials), to serve as a training centre for inspectors, to lead inspectorates to a high level of quality management, and to provide active and constructive co-operation among inspectors and between industry and inspectors on technical subjects.
PIC/S is made up of 43 participating authorities. ANSES-ANMV has been a member of PIC/S since 1995. Only two other veterinary agencies are currently members: the Czech Republic and the United Kingdom [dp1] since 1 January 2014.
Meeting in Geneva (Switzerland) from 28 to 30 May 2013 – press release (pdf)
Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods (CCRVDF)
For more information on CCRVDF
The mandate of the Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods (CCRVDF) is the following:
- to determine priorities for considering veterinary drug residues in foods;
- to recommend maximum levels of these substances;
- to develop codes of practice as required;
- to consider sampling and analysis methods for the determination of veterinary drug residues in foods.
As for the OIE, the standards established by the Codex Alimentarius are recognised as worldwide benchmarks by theWorld Trade Organization (WTO) within the framework of the Sanitary and Phytosanitary (SPS) Agreement.
Two ANSES-ANMV experts participate in this Committee, one as head of the French delegation and the other as a representative of the OIE collaborating centre.
The most recent session of the CCRVDF was held in Minneapolis (USA) from 26 to 30 August 2013. View the agenda (pdf, in French) and read the report (pdf, in French)
Signature of a cooperation agreement in the area of veterinary medicinal products with the SCIVP (Ukraine)
On 15 February 2013, the French Agency for Veterinary Medicinal Products signed a cooperation agreement with the Ukrainian State Scientific Research Control Institute of Veterinary Preparations and Feed Additives in order to improve good practices for inspection, pharmaceutical company management, the assessment of marketing authorisation (MA) dossiers, pharmacovigilance and antimicrobial resistance in Ukraine.
In October 2013, a seminar was organised in Lviv with the participation of experts from ANSES-ANMV to present good manufacturing practice (GMP) and the European Union's inspection principles. The seminar heightened awareness of both the industry and institutional participants on regulations regarding GMP, authorisations for opening manufacturing facilities, the GMP-based inspection scheme and European GMP requirements. A feedback session on GMP implementation in France was also held.
On 17 November 2010, a technical memorandum of understanding was signed between ANSES-ANMV and the China Institute of Veterinary Drug Control (IVDC), organising a training programme either in Beijing or Fougères in the various areas of activity in the domain of veterinary medicinal products. An annual meeting has been scheduled between the general directorates of the two entities in order to report on the activities conducted and to plan future initiatives.
Visit by the Chinese delegation of the IVDC to the French Agency for Veterinary Medicinal Products
From 9 to 13 September 2013, representatives of the China Institute of Veterinary Drug Control (IVDC) visited the French Agency for Veterinary Medicinal Products and ANSES headquarters in conjunction with the cooperation agreement signed on November 2010 with ANSES-ANMV. Two of its delegations received technical and scientific training, and an official delegation was welcomed by ANSES headquarters and the ANMV as part of the annual visit stipulated in the agreement. They also visited the International Livestock Trade Fair (SPACEThis meeting was an opportunity to provide a recap of past achievements and to plan the cooperation agreement's coming 2014-2015 period. IVDC's representatives expressed their satisfaction as to the success and effectiveness of the cooperation, as well as their desire to pursue efforts with a concentration on pharmacovigilance, MA assessment, Good Manufacturing and Distribution Practice and veterinary drug quality control.
ANSES-ANMV has contributed to the establishment of regional regulations for veterinary medicinal products in the West African Economic and Monetary Union (UEMOA). Since the adoption of these regulations in 2006, ANSES-ANMV has continued to provide assistance for their implementation.
As the result of an audit conducted in 2012 on GMP and GDP inspection which identified training needs, in May 2013 ANSES-ANMV organised a training session on the GMP inspection quality system. This module made it possible to provide a progress report on the quality management system, documentation, inspection procedures, internal audits, risk management, quality defects and the early warning system.