Representation on the CMDh (HMA)

The CMDh

The Coordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) examines issues concerning marketing authorisations for human medicines in two or more European Union (EU) Member States, as well as issues relating to variations in such marketing authorisations. These activities cover medicinal products for which a marketing authorisation has been granted through the Mutual Recognition Procedure (MRP), the Decentralised Procedure (DCP), and National Procedures (NPs).

If disagreements on a potential serious risk to public health arise between Member States when assessing the data submitted as part of the MRP or DCP, the CMDh will examine the matter and strive to reach an agreement within 60 days. If this is not possible, the Member State responsible for the product will refer the matter to the Committee for Medicinal Products for Human Use (CHMP) for arbitration.

The CMDh examines issues related to the safety of non-centrally authorised medicinal products, which also includes medicinal products that have been approved through national procedures. In that case, the CMDh will adopt a position on safety-related EU referral procedures, taking into consideration the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC).

Every year, the CMDh draws up a list of medicinal products for which a harmonised summary of product characteristics should be drawn up, to promote the harmonisation of marketing authorisations across the EU.

Further details of the CMDh's activities, including an overview of its duties and tasks, can be found on the CMDh website.

Luxembourg members

The PRAC member and alternate for Luxembourg are:

• Mylène Ferrier, Member
• Antoine Treff, Alternate

Their declarations of conflicts of interests are published on the EMA website.

Highlights of monthly meetings

The CMDh holds monthly meetings. After each meeting, the CMDh publishes the minutes of the meeting and a press release.