REPORTS FOR RELEASE 2023
Best Practice Guide for advice from CMDv on regulatory matters
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 veterinary medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.
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 continued existence of the CMDv was confirmed by implementation of Regulation (EU) 2019/6 applicable from 28 January 2022, according to Article 142 of the Regulation. While some tasks of the previous legislation continue to apply several new tasks have been allocated to CMDv, cited in Article 144 of the Regulation:
The CMDv shall:
(a) examine questions concerning mutual recognition and decentralised procedures;
(b) examine advice from the pharmacovigilance working party of the Committee concerning risk management measures in pharmacovigilance related to veterinary medicinal products authorised in Member States and issue recommendations to the Member States and to the marketing authorisation holders, as necessary;
(c) examine questions concerning variations to the terms of marketing authorisations granted by Member States;
(d) provide recommendations to Member States whether a specific veterinary medicinal product or a group of veterinary medicinal products is to be considered a veterinary medicinal product within the scope of this Regulation;
(e) coordinate the selection of the lead authority responsible for the assessment of the results of the signal management process referred to in Article 81(4);
(f) draw up and publish an annual list of reference veterinary medicinal products which shall be subject to harmonisation of the summaries of product characteristics in accordance with Article 70(3).
Particularly in case of disagreement between the Member States involved in a mutual recognition, a subsequent recognition procedure or a decentralised procedure - in relation to the assessment report, the summary of product characteristics, the labelling or the package leaflet - the points of disagreement are considered by the CMDv. The CMDv uses its best endeavors to reach agreement on the action to be taken within the 90-day time period of the CMDv review procedure according to article 54of the Regulation.
The CMDv is composed of one representative per Member State, including Norway, Iceland and Liechtenstein, appointed for a renewable period of three years. The list of the CMDv members is published on the CMDv website. Representatives of the European Commission, the Agency (EMA) and observers, 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 Amsterdam or virtually. The CMDv meetings, including working groups, take place during the week of the Committee for Medicinal Products for Veterinary Use (CVMP) meeting. Presidential 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.
Regular meetings are organised with stakeholders of the CMDv: representatives from industry and from veterinarians’ associations.
Rules of Procedure (January 2022)
CMDv Contact details
Domenico Scarlattilaan 6
1083 HS Amsterdam
email: CMDv@ ema.europa .eu
Telephone: +31 (0)88 781 7807