1. Legal bodies responsible for regulatory procedures

1.4. Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h))

The CMD(h) is an HMA working group responsible for a smooth functioning of the mutual recognition and the decentralised procedures for human medicines and is responsible for the coordination of any scientific/regulatory issue related to these products.

It has particularly been set for the examination of any question relating to a MA, pharmacovigilance or variations of a medicine in two or more MS in accordance with the mutual recognition or the decentralised procedure.

Applications for a mutual recognition or a decentralised procedure which are submitted to the NCAs involved in the procedure are overseen by the CMD(h).

The Group also deals with issues related to national procedures when needed. For example, when the same product is authorised in different countries through the national procedure (before the MRP was mandatory) and requires any action related to harmonisation, safety, etc.

Further information:  http://www.hma.eu/cmdh.html

Article 27, Directive 2001/83/EC