CRED ERP 25

12. Role of the Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)

In 1995, to help coordinate MRP procedure a Mutual Recognition Facilitation Group (MRFG) was established. This has now been replaced with the CMDh under Directive 2004/27/EC (article 27 of Directive 2001/83/EC. This group is chaired by one member for three (3) years with an appointed senior representative from each Member State. The secretariat for the CMDh group is provided by EMA. The CMDh is set up 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.

The group may also identify issues that may need to be raised to the European Commission, Heads of Medicines Agency (HMA), or other interested parties as needed. Specific processes and procedures followed by CMDh are listed on their website (https://www.hma.eu/human medicines/cmdh.html) for further consideration.

This group is an independent coordination group that provides a forum between the parties on resolving issues.

Further reading: https://www.hma.eu/human-medicines/cmdh.html

https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_ for_MA/MRP_RUP/CMDh_081_2007_Rev.3_2020_02_clean.pdf

https://www.hma.eu/human-medicines/cmdh/procedural-guidance/general-info.html

https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_ for_MA/MRP_RUP/CMDh_082_2002_Rev.15_10_2021_- _MRP_Guidance_on_Submission_Dates.pdf

13. Questions? If you have questions/clarifications then please note them here and raise them during Q&A or alternatively send any questions you would like to raise during the course to the following e-mail address: meetings@topra.org