CRED ERP 25

DCP The DCP was implemented in Directive 2001/83/EC (articles 28.1; 28.2 and 28.4) through Directive 2004/27/EC and introduced in the EU in 2005. It was intended to allow first time Marketing Authorisations (MA’s) for a product in severa l Member States (MS) simultaneously, when no MAs had been granted in the European Economic Area (EEA) at the time of application. The DCP shares similar concepts and procedures to MRP in the sense that it allows a harmonised approach to life cycle management as the core technical details registered are the same throughout the applicable MS.

Key facts: •

Only applicable if no MAs exist in EEA.

• Like MRP the assessment is carried out by one MS (the RMS).

• Co-ordination group for Mutual recognition and Decentralised procedure – human (CMDh) co-ordinates the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). • The procedure takes (maximum) 210-days (excluding one clock off period) to reach consensus amongst MS’s. This is followed by a National phase in each MS to grant the national MA (Article 28.5 of Directive 2001/83/EC).