CMDH | WHAT'S NEW
Variations [Track version]
Article 45 work-sharing-Simeticone
'Blue-box' requirements (May 2017)
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 authorisations 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.
This very broad scope for the CMDh is complemented by specific tasks laid down in the legislation:
- aim to solve disagreements on the grounds of potential serious risk to public health between the Member States involved in a mutual recognition or decentralised procedure;
- examination of questions related to the pharmacovigilance (Art. 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC);
- examination of questions related to variations;
- laying down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.
To fulfil its tasks the CMDh has established several working parties/working groups, currently:
- Process Improvement working party - responsible for drafting proposals for implementation of new legislation, administrative and procedural harmonisation and simplification;
- Joint CMD/CHMP/CVMP/EMA/QWP/EDQM working group on ASMF procedures - responsible for developing work-sharing procedures for ASMF assessment;
- Joint CMD/EMA working party on variation regulation - responsible for drafting guidance documents relating to variations;
- Joint CMDh/EMA working party on paediatric regulation - responsible for helping with the coordination of work-sharing assessment of paediatric data;
- Working Party on Pharmacovigilance Procedures Work Sharing - responsible for the finalisation of the PSUR work-sharing project for purely national active substances and to develop procedures for RMPs;
- Joint CMDh/GCP Inspectors working party - responsible for preparing inspection programmes;
- Communication Tracking System (CTS) working group - responsible for maintaining and developing the MRP and DCP tracking system and the publicly available product index.
The CMDh is composed of one representative per Member State and Norway, Iceland and Liechtenstein, appointed for a renewable period of three years. Member States may appoint an alternate to the CMDh member. The list of the CMDh Members and alternates, their professional qualifications and declarations of interest are published on the CMDh and EMA websites. The European Commission participates on a regular basis as an observer. Observer status can be granted in line with the CMDh Rules of Procedure to other institutions (e.g. accession countries).
The Chairperson of the CMDh is elected for a term of three years.
According to the Rules of Procedure, the CMDh has one elected Vice-Chairperson elected for a term of three years. A second Vice-Chairperson is appointed by the Member State currently holding the Presidency of the Council of the European Union for the duration of the term of the presidency.
The CMDh holds monthly meetings at the European Medicines Agency which usually have a duration of 3 days. The European Medicines Agency provides the secretariat of the CMDh.
Press releases with statistics, guidance documents, Q&As and information on applications referred to the CMDh are published monthly on the CMDh website.
The CMDh also publishes, on a yearly basis, a summary of the activities carried out by the CMDh and yearly statistics for new applications in the mutual recognition and decentralised procedures and for the applications referred to the CMDh.
There is regular co-operation and exchanges of information on matters of mutual interest to both human and veterinary Co-ordination Groups, with regards to the mutual recognition and decentralised procedures.