Committee for Medicinal Products for Veterinary Use (CVMP)
The Committee for Medicinal Products for Veterinary Use (CVMP) is the European Medicines Agency's (EMA) committee responsible for veterinary medicines.
The CVMP was established in line with Regulation (EC) No 726/2004.
Role of the CVMP
The CVMP plays a vital role in the authorisation of veterinary medicines in the European Union (EU). In the centralised procedure, the CVMP is responsible for:
- conducting the initial assessment of EU-wide marketing authorisation applications;
- post-authorisation and maintenance activities, including the assessment of any modifications or extensions ('variations') to an existing marketing authorisation;
- safety monitoring of veterinary medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market. For more information, see Veterinary pharmacovigilance.
The CVMP also evaluates veterinary medicines authorised at national level referred to EMA for a harmonised position across the EU. For more information, see Veterinary referral procedures.
The CVMP recommends safe limits for residues of veterinary medicines used in food-producing animals and biocidal products used in animal husbandry, for the establishment of maximum residue limits by the European Commission.
In addition, the CVMP and its working parties contribute to the development of veterinary medicines and medicine regulation, by:
- providing scientific advice to companies researching and developing new veterinary medicines;
- preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications for veterinary medicines;
- cooperate with international partners on the harmonisation of regulatory requirements.
The CVMP's assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that is has a positive risk-benefit balance in favour of the animal population they are intended for.
A peer-review system safeguards the accuracy and validity of the opinions of the committee.
For full details, see: