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Function and Tasks of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human

Based on Directive 2001/83/EC , as amended by Directive 2004/27/EC a coordination group for mutual recognition and decentralised procedures for human medicinal products (CMD(h)) has been established , for which the EMEA provides the secretariat. It is the task of the coordination group to review all questions raised with the authorisation of medicinal products by way of either DCP or MRP. The CMD(h) held their first meeting on 14 November 2005 and gave itself rules of internal procedure. In agreement with the European Commission and Heads of Agencies, these rules were published and came into force in 2006.

Tasks specified in the Pharmaceutical Legislation

Directive 20001/83/EC as amended defines the tasks of CMD(h) in the following articles.

Article 27(1)

A coordination group should be set up for the examination of any question relating to marketing authorisation of medicinal product in two or more Member states.

Article 29(1) and (3)

In the case of disagreement between Member States on the grounds of potential serious risk to public health, the application will be considered by the CMD(h) and MS will use their best endeavours to reach agreement on the action to be taken.

In the case of an unsolved disagreement in a specific procedure, the matter must be referred to the CHMP for arbitration.

Further information on the mandate and the role of the CMD(h) can be found on the website of the Heads of Regulatory Agencies .