INTRODUCTION
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, CMDh, has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/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.
The CMDh has also the following specific responsibilities, as laid down in the revised Pharmaceutical Legislation:
- In case of disagreement between the Member States involved in a Mutual recognition or decentralised procedure on the Assessment report, the summary of product characteristics, the labelling or the package leaflet on the grounds of “potential serious risk to public health”, the points of disagreement are considered by the CMDh. The CMDh uses its best endeavours to reach agreement on the action to be taken within the 60 day time period foreseen in the legislation.
- To lay down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up, to promote harmonisation of marketing authorisations across the Community.
The CMDh has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.
The CMDh 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 CMDh Members, together with the respective professional qualifications is published on the CMDh website. Observers from the European Commission and accession countries also participate in the meetings of the CMDh.
Dr. Peter Bachmann has been elected Chairperson of the CMDh for a term of three years.
The Vice-Chairperson of the CMDh is appointed from among the members of the CMDh by the Member State which holds the presidency of the Council of the European Union for the duration of the term of the presidency.
The CMDh holds monthly meetings at the European Medicines Agency. The CMDh meetings take place on the week of the CHMP and have a duration of 2 to 3 days, which reflects the extended scope of CMDh activities compared to the informal Mutual Recognition Facilitation Group. The European Medicines Agency is responsible for providing the secretariat of the CMDh.
Approximately half of the time of the CMDh meeting is dedicated to discussions on procedural/regulatory issues, development of Guidance documents and oversight of the activities of the various CMDh Sub-groups/Working groups whilst the other half is devoted to trying to reach agreement for applications referred to the CMDh, in case of disagreement between Member States on the grounds of a potential serious risk to public health.
Prior to the entry into force of the revised Pharmaceutical Legislation, the Heads of Agencies set up an ad hoc Working Group, to consider the role of the new Co-ordination Groups for Mutual recognition and decentralised procedures. The report from this ad hoc Working Group is available on the Heads of Medicines Agencies website.
The Heads of Agencies agreed that the mission of the CMDh would be:
- To aim for consensus and avoid referrals to the CHMP other than in exceptional cases of disagreement on the grounds of “potential serious risk to public health”;
- To ensure consistency of standards and good quality decision making across the EU in the interests of public health;
- To achieve the harmonisation of SmPCs of nationally authorised products in particular cases that would benefit citizens of the Community;
- To present a harmonised view on the interpretation of Directives and Regulations in order to facilitate implementation and finding solutions.
Press releases with statistics, guidance documents, Q&As and information on applications referred to the CMDh are published monthly on the CMDh website.
The CMDh also publishes, on a yearly basis, a summary of the activities carried out by the CMDh and yearly statistics for new applications in the Mutual recognition and Decentralised procedures and for the applications referred to the CMDh.
There is a comparable Group in the veterinary area, the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Veterinary, CMDv and a close link has been established between both Groups.
November 2011