CRED ERP 25

Quick Reference Guide to Mutual Recognition Procedure (MRP)

MRP Background: The MRP was first introduced into the EU in 1995. It was designed to ensure an efficient/harmonised assessment procedure in cases where multiple applications for the same product were made to National Competent Authorities across the EEA.

The need for this harmonisation came about due to difficulties seen in life cycle management where a product approved across different markets was often the subject of differing assessments with resulting divergence in Product Information.

The MRP aimed to introduce efficiency and consistency to assessment process where the same product is authorised Nationally across a number of different Member States and serves to reduce duplication of effort by both Applicants and NCAs both during initial assessment and subsequent life-cycle management.

Key Points: •

There must be an existing approved Marketing Authorisation (MA) in a Member State (MS), referred to as Reference Member State (RM S); this is then subsequently “recognised” by other MS (referred to as Concerned Member States (CMS). • Initial assessment is carried out by one MS (the RMS). • The CMS “mutually recognise” the assessment and marketing authorisation conducted/granted by the RMS. • If there are any major objections raised by the CMS, these must be raised on the grounds of a Potential Serious Risk to Public Health (PSRPH). • The Co-ordination groupfor Mutual recognition and Decentralised procedure – human (CMDh) is responsible for the coordination and processes by issuing e.g. Best Practice Guides/SOPs and discussing specific issues. • The MRP follows a 90-day period at maximum if consensus amongst CMS is reached. • This is followed by a National Phase in each MS. • In case no consensus is reached by day 210 of the procedure, the issue for which no consensus is reached will be referred to CMDh.

MRP Process Flow chart:

Day -90

Applicant requests RMS to update Assessment Report

Applicant submits application to RMS and CMSs for review

CMS validates the application

Day -14

CMS reviews assessment report and generates comments

RMS starts the procedure

Day 30

Day 0

Applicant sends response to RMS and CMSs

CMS sends remaining comments from Applicant response

Day 40

Day 55

Comments resolved?

Yes

RMS closes procedure

Day 60

No

CMS send their remaining comments to RMS, CMS, and Applicant

Applicant sends response document to CMSs and RMS

Day 75

Consensus reached?

Yes

RMS closes procedure

Day 90

No

Applicant sends English PI and labelling to CMSs

National marketing authorization in each of the CMS

Referred to CHMP for arbitration

Consensus not Reached

Final position adopted by CMDh

Day +5 Post Procedure

Day +30 Post Procedure

Day 150