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TC GUI-02 Sunset Clause
GUI-002 Administration of the Sunset Clause
The role of CMDv
The CMDv was set up in the revised pharmaceutical legislation (Directive 2004/28/EC amending Directive 2001/82/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.
Particularly in case of disagreement between the Member States involved in a mutual recognition or decentralised procedure - in relation to the assessment report, the summary of product characteristics, the labelling or the package leaflet on the grounds of “potential serious risk to human, or animal health or to the environment” - the points of disagreement are considered by the CMDv. The CMDv uses its best endeavours to reach agreement on the action to be taken within the 60-day time period foreseen in the legislation.
The CMDv started its activities in November 2005 and replaced the previous, informal Veterinary Mutual Recognition Facilitation Group (VMRFG), which held its first meeting in April 1997.
The CMDv is composed of one representative per Member State, including Norway, Iceland and Liechtenstein, appointed for a renewal period of three years. The list of the CMDv members, together with their respective professional qualifications, is published on the CMDv website. Observers from the European Commission and accession countries, where applicable, also participate in the meetings.
The CMDv holds monthly meetings, except for the month of August, at the European Medicines Agency (EMA), based in London. The CMDv meetings, including ad-hoc and sub working groups, take place during the week of the Committee for Medicinal Products for Veterinary Use (CVMP) meeting and last two days. Informal meetings can be organised and held at the Member State holding the presidency of the European Union. The EMA provides the secretariat of the CMDv.
Rules of Procedure – updated in Sept 2015
CMDv Contact details
European Medicines Agency
30 Churchill Place
Canary Wharf, London
Telephone: +44 (0)20 3660 7807