Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) was set up in 2005. It replaced the informal Mutual Recognition Facilitation Group.
The 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.
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).
The CMDh is composed of one representative per Member State (plus Norway, Iceland and Liechtenstein), appointed for a renewable period of three years. Member States may also appoint an alternate member, and observers from the European Commission and EU accession countries also participate in meetings. Information on the members and alternates of the CMDh is available on the CMDh website.
The European Medicines Agency (EMA) provides the secretariat to the CMDh.
Meetings and reports
The CMDh positions adopted in the context of safety-related referral procedures are currently published on the EMA website. Once a CMDh position is adopted, the EMA also publishes a press release summarising the CMDh position.
The CMDh website contains further information on the CMDh and its work, including statistics, guidance documents, question-and-answer documents, work plans, annual reports and information on the applications referred to the CMDh.