Committee for Medicinal Products for Veterinary Use (CVMP)

Overview

Role and responsibilities

The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing the Agency's opinions on all questions concerning veterinary medicinal products, in accordance with Regulation (EC) No 726/2004.

The CVMP plays a vital role in the marketing procedures for medicines in the European Union:

In the ‘Community’ or ‘centralised’ procedure, the CVMP is responsible for conducting the initial assessment of veterinary medicinal products for which a Community-wide marketing authorisation is sought. The CVMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to the existing marketing authorisation.
In the ‘mutual-recognition’ and ‘decentralised’ procedures, the CVMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular veterinary medicinal product (‘arbitration procedure’). The CVMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake (‘Community referral procedure’).

Assessments conducted by the CVMP are based on purely scientific criteria and determine whether or not the products concerned meet the necessary quality, safety and efficacy requirements (in accordance with EU legislation, particularly Directive 2001/82/EC). These processes ensure that veterinary medicinal products that reach the marketplace have a positive risk-benefit balance in favour of the animal population they are intended for.

Subsequent monitoring of the safety of authorised products is conducted through the EU’s network of national veterinary medicines agencies, in close cooperation with veterinary professionals and the pharmaceutical companies themselves. The CVMP plays an important role in this EU-wide ‘pharmacovigilance’ activity by closely monitoring potential safety concerns and, when necessary, can make recommendations to the European Commission regarding changes to a product’s marketing authorisation or the product’s suspension/withdrawal from the market.

A core activity of the CVMP is the establishment of MRLs: the 'maximum residue limits' of veterinary medicinal products permissible in food produced by or from animals for human consumption, including dairy products, meat, honey etc. These limits must be established for all pharmacologically active substances contained in a medicinal product before the product can be granted a marketing authorisation.

Other important activities of the CVMP and its working parties include:

the provision of assistance to companies researching and developing new veterinary medicines;
the preparation of scientific and regulatory guidelines for the veterinary pharmaceuticals industry;
cooperation with international partners on the harmonisation of regulatory requirements for veterinary medicines.

Composition

CVMP members and alternates are nominated by the Member States, in consultation with the European Medicines Agency Management Board, and are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicinal products. They serve on the committee for a renewable period of three years.

The CVMP is composed of:

a chairman, elected by serving CVMP members;
one member (and an alternate) nominated by each of the 27 EU Member States;
one member (and an alternate) nominated by each of the EEA-EFTA states Iceland and Norway;
up to five co-opted members, chosen among experts nominated by Member States or the European Medicines Agency and recruited, when necessary, to gain additional expertise in a particular scientific area.

See CVMP members for the list of current members.

Rules of procedure

The 'CVMP rules of procedure' (soon to be available in all official EU languages) provide full details of the CVMP's responsibilities, composition and the roles of its members.

Language:

See glossary of language abbreviations (Pop-up screen)