CRED ERP 25

The MRP procedure was also created to ensure that the same medicinal product in the EU would have the same SmPC, etc., in order to present harmonised products throughout the EU market. The requirement for harmonising arose due to the need for ease in lifecycle management of the same product in different markets. A more efficient and accurate way of ensuring the product ’ s quality, efficacy and safety at the same time throughout the EEA for non-centralised licensed products became possible thanks to MRP. The MRP allowed for a reduction in duplication of work by Marketing Authorisation Holders (MAH) by being able to harmonise National licences in various markets for the same product (the handling of individual national licencing was very time consuming and very risky if urgent changes to the licences needed to be made at the same time such as in a safety change).

Key facts: •

There must be an approved marketing authorisation (MA) in a member state which is then subsequently recognised by other Member States (MS) and is referred to as the Reference Member State (RMS). These other member states which recognise and subsequently authorise an MA (Nationally) are known as Concerned Member States (CMS).

• First assessment is carried out by one MS (referred to as the Reference Member State [RMS]).

• Co-ordination group for Mutual recognition and Decentralised procedure – human (CMDh) co-ordinates the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). • After start of the procedure a (maximum of) 90-day period is possible to reach consensus amongst MS’s ; this may be finished as early as Day 60. This is followed by a National phase in each MS to grant the national MA (Article 28.5 of Directive 2001/83/EC).