Decentralised Procedure Member State’s Standard Operating Procedure

According to Article 28(1) of the Directive 2001/83/EC as amended, we have in the European Union beside the Mutual Recognition Procedure (MRP) and the Centralised Procedure (CP) a new procedure for the marketing authorisation of medicinal products which is called Decentralised Procedure (DCP). The new procedure is very similar to the Mutual Recognition Procedure and will be handeled by the The Mutual Recognition Facilitation Group (MRFG), as well. By end of March 2005, MRFG published a first draft of the Decentralised Procedure Member State’s Standard Operating Procedure.