CRED ERP 25

Quick Reference Guide to Decentralised Procedure (DCP)

Background: The DCP was first implemented through Directive 2004/27/EC and introduced in the EU in 2005. It allows for simultaneous submission of an application for a product across several Member States (MS) where there is no existing Marketing Authorisation (MA) for planned marketed product in the EEA yet. The DCP shares similar concepts to the Mutual Recognition Procedure (MRP) in the sense that it permits a harmonised approach/assessment to approval and life cycle management as the core technical details registered are intended to be and remain the same across each MS. Only applicable if no MA’s exist in EEA for the product in question. • Like MRP the assessment is carried out by one MS, defined as Reference Member State (RMS). • Subsequent to this, CMSs review the assessment of the RMS and generate any additional comments if needed. • The applicant responds to the questions raised by RMS and CMSs. • The Co-ordination group for 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 • If consensus is reached at day 210 (could also be earlier than day 210) on the assessment report of the RMS, the procedure ends positively. • 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. Key Points: •

DCP Flow chart:

Assessment Step 1

Applicant submits application to RMS and each CMS for review

RMS and CMS validates the application

Assessment Step 2

Day -14

CMS reviews the assessment report and generates comments

RMS circulates Day 70 Preliminary Assessment Report

RMS starts procedure, CMS notified via CTS

Day 0

Day 100

Day 70

RMS sends draft assessment report and labelling, PL, SmPC

CMS reviews the assessment report and generates comments

Draft responses up to 3 or 6 months

Clock stops

Day 120

Day 105

Communicate outstanding issues with applicant

Consensus achieved?

Yes

No

Day 150 (Day 30)

Day 195

National marketing authorization in each of the CMS

RMS consults with CMS and discussion with applicant

Yes

Day 210 (Day 90)

Consensus achieved?

Review by Co ordination group

No

Day 270