CMDh

The CMDh started its activities in November 2005, replacing the informal Mutual Recognition Facilitation Group (MRFG), which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), was set up in Directive 2004/27/EC for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.

The task of the CMDh was substantially extended in 2012 by Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.

 CMDh Working Parties

 

Working Group on Active Substance Master File Procedures

Process Improvement Working Party

Working Party on Paediatric Regulation

Working Party on Variation Regulation

Working Party on Harmonisation of SmPCs

Working Party on Pharmacovigilance Procedures Work Sharing

CTS Working Group

Joint CMDh/GCP Inspectors Working Party

Created: 30.09.2015

© Austrian Federal Office for Safety in Health Care
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