Since 1 January 1995 and the creation of the European Medicines Agency (EMA), three European procedures for marketing authorisation (MA) of medicines have been operating within the European Union: a centralised procedure involving the EMA, a decentralised procedure (MA granted simultaneously in several member States), and a procedure for mutual recognition of MAs granted by national agencies, involving the European Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh). The scope of the CMDh’s work includes useful drugs which have been marketed for many years.
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