Committee for Medicinal Products for Veterinary Use holds 200th meeting

15 April 2013

Last week, the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) celebrated its 200th meeting since its creation in January 1995.

The CVMP is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines. These activities include scientific advice for the development of products, the initial assessment of veterinary medicines for which a European Union (EU)-wide marketing authorisation is sought, arbitration in cases where there is a disagreement between Member States or where the interests of the European Union are at stake, and scientific opinions where expert scientific input is sought on issues related to veterinary medicines.

Another core activity of the CVMP is the establishment of the maximum residue limits (MRLs) of veterinary medicines permissible in food produced by, or from, animals for human consumption, including, meat, milk, eggs and honey.

Since its creation, the CVMP has:

• issued 150 positive opinions for new veterinary medicines;
• established MRLs for over 800 substances used in veterinary medicinal products for food-producing animals;
• recommended 91 extensions and 1,350 variations of use of veterinary medicines;
• finalised 152 scientific-advice requests;
• issued 86 recommendations following referral procedures;
• prepared over 130 guidelines on quality (31), safety (30) and efficacy (33) for pharmaceutical and immunological (43) veterinary medicines.

Supporting the development of veterinary medicines

The CVMP has always placed great importance on providing support to applicants seeking authorisation of innovative medicines. Applicants can benefit from scientific advice from the CVMP and presubmission meetings with the Agency's staff and the Committee's rapporteurs.

In addition, the Agency provides specific assistance to micro, small and medium-sized enterprises (SMEs). Since the creation of the SME office in 2005, more than 100 SMEs in the veterinary area have registered with the Agency.

For the first time in 2013, veterinary medicines will be included in the Agency's Innovation Task Force. In addition, the CVMP will provide advice to the European Commission on how best to accommodate novel therapies as part of the review of veterinary legislation.

In 2009, the CVMP started a reflection to promote development of veterinary medicines indicated for minor uses, minor species (MUMS) and limited markets. This led to the establishment of a , which includes incentives to support these products. As highlighted by the third annual report on the policy, which will be published shortly, so far this policy has been highly successful in terms of increasing interest from the animal-health industry in submitting applications for MUMS products.

On average, 23 products are classified each year. These classifications are starting to result in newly authorised products for minor species and limited markets and have also resulted in increasing applications for scientific advice. At their meeting in April 2013, the Agency's Management Board agreed that the Agency should review the operation of the policy together with the Heads of Medicines Agencies to ensure that financial support is directed to support those applications most deserving of public support. This work is now ongoing.

Minimising the risks of antimicrobial resistance

Since its inception, the CVMP has played a major role in providing scientific advice on how best to minimise the risks of antimicrobial resistance arising from the use of antibiotics in veterinary medicine. This issue is now of global importance in view of increasing threat from antimicrobial resistance and the recognition that meaningful control will only be possible by adopting a 'one health' approach. This approach recognises that the responsible use of antibiotics needs to be promoted in a coordinated way in both human and animal healthcare settings.

In this area, the CVMP published a CVMP strategy on antimicrobials 2011-2015 in 2011 to promote the continued availability of effective antimicrobials for use in animals whilst at the same time acting to minimise risks to animals or man arising from their use.

The CVMP, together with the Committee for Medicinal Products for Human Use (CHMP), has recently been asked to make a major scientific contribution to this debate by means of a request for advice from the European Commission on the impact of the use of antibiotics in veterinary medicine on human and animal health.