The Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) examines questions relating to the marketing authorisation of veterinary medicines in two or more European Union (EU) Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMDv was set up in 2005 and replaced at that time the informal Veterinary Mutual Recognition Facilitation Group.
The main purpose of the group is the coordination and facilitation of the operation of the mutual recognition and decentralised procedures and to consider points of disagreement raised by Member States during Mutual Recognition or Decentralised procedures in relation to the assessment report. Summary of Products Characteristics, Labelling and Package Leaflet of a veterinary medicinal product related to new applications, variations and renewals. The group shall provide recommendations on the classification of unforeseen variations and shall perform and support work sharing between Member States where appropriate.
The CMDv is composed of one expert/representative per National Competent Authority (plus Norway, Iceland and Liechtenstein). Observers from the European Commission and EU accession countries may also participate in meetings. At present, Gavin Hall (Veterinary Medicines Directorate, VMD) is the chairman.
The Committee for Medicinal Products for Veterinary Use (CVMP is responsible for the benefit-risk assessment of medicines for veterinary use. The CVMP plays a vital role in the marketing procedures for medicines in the European Union concerning the ‘centralised’ 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). These processes ensure that veterinary medicines that reach the marketplace have a positive benefit-risk 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. 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, eggs, honey etc.
The members and alternates of the CVMP are nominated by their National Competent Authorities of their Member States.
25 June 2017 until 27 June 2017
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