The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines, 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 ‘centralised’ or ‘Community’ procedure, the CVMP is responsible for conducting the initial assessment of veterinary medicines for which an EU-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 an 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 medicine (‘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 medicines concerned meet the necessary quality, safety and efficacy requirements (in accordance with EU legislation, particularly Directive 2001/82/EC). These processes ensure that veterinary medicines 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 medicines 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, it can make recommendations to the European Commission regarding changes to a medicine’s marketing authorisation, or its suspension/withdrawal from the market.
A core activity of the CVMP is the establishment of MRLs: the 'maximum residue limits' of veterinary medicines 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 medicine before it 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.
The 'CVMP rules of procedure' provide full details of the CVMP's responsibilities, its composition and the roles of its members.
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European Medicines Agency
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