Representation on the CMDh (HMA)

The CMDh

The Coordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) examines questions relating to the marketing authorisation of human medicines in two or more European Union (EU) Member States in accordance with the mutual recognition or the decentralised procedure, and questions concerning variations of these 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 there is disagreement between Member States during the assessment of the submitted data based on the grounds of a potential serious risk to public health, the CMDh considers the matter and strives to reach an agreement within 60 days. If this is not possible, the Member State responsible for the product brings the case to the attention of the Committee for Medicinal Products for Human Use (CHMP) for arbitration.

The CMDh examines questions concerning the safety of non-centrally authorised medicines marketed in the EU where centrally authorised products are not affected. This includes adopting a CMDh position on safety-related EU referral procedures, taking account of the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC).

Each year the CMDh identifies a list of medicines for which harmonised product information should be drawn up, to promote the harmonisation of marketing authorisations across the EU.

More information about the CMDh's activities, including an overview of its functions and tasks, can be found on the CMDh website.

Luxembourg members

The CMDh 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.