[Marketing of medicinal products in the European Community. The Mutual Recognition and Decentralised Procedures].
The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.
Bachmann
Peter
P
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, Bonn, BRD. p.bachmann@bfarm.de
D003299:Cooperative Behavior; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry / Q000458:organization & administration*; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D007373:Interinstitutional Relations; D007880:Legislation, Drug; D040541:Marketing / Q000458:organization & administration*; D004364:Pharmaceutical Preparations
D004364:Pharmaceutical Preparations