Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The new CMD(h) - a chance for reaching agreement in MRP and DCP? ***

Johanna Walter, (geb. Bleicher) (Abschlußjahr: 2007)

Language: English

The Mutual Recognition Facilitation Group (MRFG) was established in 1995 to coordinate and facilitate the operation of the MRP (Mutual Recognition Procedure) and was regarded as a major player in the European system. However the lack of a legal basis and the fact, that the group could not discuss scientific problems related to individual applications were recognised as a clear disadvantage for solving issues in MRPs.

With the revision of the legislation, the already existing cooperation group MRFG became an official status and was renamed Coordination Group for Mutual Recognition and Decentralised Procedures (human) (CMD(h)).

The new CMD(h) is composed of one representative per EU member state, who is appointed for a period of three years. The MRFG was chaired by the country which held the presidency of the EU and therefore a new person was appointed every six months. For a better consistency of decisions this procedure has been changed with the new legislation and so the chairperson of the CMD(h) is elected by and from amongst its members for a period of three years which could be renewed once.

It should also be mentioned that the new legislation established many new transparency measures for the procedures and also for the CMD(h). Therefore the group published its "rules of procedure" and also the membership and professional qualifications of each member.
According to Article 27 of Directive 2001/83/EC as amended the coordination group is "set up for the examination of any question relating to the marketing authorisation of a medicinal product in two or more member states" in the MRP and DCP (Decentralised Procedure) and is, according to the Notice to Applicants, "responsible for the smooth functioning and good outcomes of the MRP and DCP with a mix of regulatory and scientific work".

This definition covers a variety of tasks, for example the 60 days CMD(h) procedure.
If a member state raises grounds for supposing that the authorisation of the medicinal product concerned may present a potential serious risk to public health, the procedure will be referred to the CMD(h).

Based on Article 29(2) of Directive 2001/83/EC as amended the European Commission adopted a guideline that defines in which exceptional cases a member state can refuse to recognise a marketing authorisation (MRP) or a positive assessment (DCP) on the basis of a potential serious risk to public health.

The involved countries should use their best endeavours to find a solution in the 60 days CMD(h) procedure. In the exceptional case that the CMD(h) is unable to reach agreement an arbitration procedure will be initiated, leading to a single decision on the area of disagreement and binding on the member states concerned. The goal of the coordination group is to solve the majority of issues and avoid article 29 referrals.

The 60 days CMD(h) procedure is applicable for new MRP and DCP applications, repeat use submissions, extensions and renewals. It should be mentioned that variations are excluded, as they are not covered by the legislation, but could be discussed in the regular work of the coordination group.

This thesis gives an overview of the tasks, composition and transparency measures of the CMD(h) and the difference to its predecessor MRFG. After a short description of the procedures that lead to referral to the coordination group and the 60-days CMD(h) procedure itself, a statistical evaluation of the number and reasons of new CMDs, outcome of the 60 days procedure and the cases that have to be referred to arbitration, will follow. Last but not least the advantages and disadvantages of the new group will be discussed and also proposals for improvement considered.

Pages: 59
Annexes: Pages 25