CRED ERP 25

European Regulatory Procedures: Decentralised and Mutual Recognition Procedures

The objective of this pre-read summary of the Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) is to enable you to become familiar with the key features of the “mechanics” of the DCP and MRP before attending the TOPRA CRED course on EU Regulatory Procedures. The DCP and MRP have been combined into a single pre-read document; similarities and differences will be discussed throughout the document. During the course itself, expert speakers will give a brief outline of the different EU regulatory procedures and how they work and will then focus on covering real-life examples of what running these procedures inpractice entails, how best to organise your company team internally as well as covering common pitfalls and how to avoid them. In order for you to get the most out of the course and the presentations, a certain amount of background reading and study on your part is required. The presenters will assume that you have reviewed the pre-read materials and that you are at least familiar with the following topics:

1. Legal basis and background to MRP and DCP 2. Overview of the procedures and key definitions 3. Initial Registration Strategy 4. General Principles of the Procedures

5. Managing the Procedure: MRP 6. Managing the Procedure: DCP

7. Completing Submission Process: Mutual Recognition Procedure 8. Completing Submission Process: Decentralised Procedure 9. Managing the Procedure: Achieving Consensus and MA 10. Mutual Recognition Repeat Use 11. Duplicate Licences 12. Role of the Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) 13. Questions for TOPRA presenters

By ensuring that you have familiarised yourself with this material in advance enables presenters to further elaborate on the reality of how these procedures work in practice versus thetheory.

1. Legal basis and background to MRP and DCP

The legal basis for the establishment of the Mutual Recognition Procedure is laid down in Medicinal Products Directive (MPD) 2001/83/EC (articles 28.2 and 28.3) and Regulation (EC) No 1234/2008 (so called variation regulation) of the European Parliament. The regulation also stipulates that any subsequent variations, changes, or line extensions for products authorised through the DCP/MRP must subsequently be processed through use of the MRP. It should be noted that the DCP has been in force since November 2005. The Directive (Article 27) also establish a Co-Ordination Group for Mutual Recognition and DecentralisedProcedures – Human (CMDh) representing the Member States of the EU. The EMA provides the secretariat of the CMDh. MRP The MRP was first introduced within the EU in 1995. It was established in order to ensure that an efficient procedure for harmonising national licenses for a particular product in the EEA was available.