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 (CMDh, http://www.hma.eu/cmdh.html) has been established, for which the EMA 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 the decentralized procedure (DCP) or the mutual recognition procedure (MRP). The CMDh 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 and have since been regularly updated.

Tasks specified in the Pharmaceutical Legislation

Directive 2001/83/EC lays down, inter alia, in Articles 27 and 29, the tasks of the coordination group:

The coordination group is responsible for examining all questions relating to the marketing authorisation of a medicinal product in two or more Member States (MRP/DCP) and pharmacovigilance issues. In carrying out its pharmacovigilance tasks, including the authorisation of risk management systems and the monitoring of their effectiveness, the coordination group shall rely on the scientific evaluation and recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC).

The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Member States may appoint an alternate for a renewable period of three years. The members of the coordination group may be accompanied by experts.

In carrying out their tasks, the members of the coordination group and the experts shall rely on the scientific and administrative resources available to the competent national authorities. Each national competent authority shall monitor the technical level of the evaluations carried out and assist the designated members of the coordination group and the experts in their work.

Where a Member State in an MRP/DCP cannot approve the assessment report and the proposed product information due to a potential serious risk to public health, it shall provide the reference Member State, the other Member States concerned and the applicant with a detailed justification. The points of disagreement shall be notified immediately to the coordination group. Within the coordination group, all Member States shall make every effort to reach agreement on the measures to be taken. They shall give the applicant the opportunity to present his views orally or in writing.

Further information on the mandate and the role of the CMDh can be found on the website of the Heads of Regulatory Agencies .