Spring Intro 2023

03/03/2023

Approval Timelines

4

210 + 67

3

210 + 30

2

210 + 60 +90

1

> 400?

0

100

200

300

400

500

Time (Days)

1 Year

2 years

The Organisation for Professionals in Regulatory Affairs

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Strategic Considerations Centralized Procedure (CP) One MAA is submitted to EMA, Rapp/Co-Rapp and CHMP members. One application and one assessment (logistically easier to handle). Request Rapporteur 7 months in advance of proposed submission date EMA chooses the Rapporteur /Co-Rapporteur for the assessment (based on recent experience and availability) All or nothing procedure, as the MAA is either accepted or rejected in all EU Member States

Decentralised Procedure (DCP)

Applicant chooses the RMS (usually with the most relevant assessment expertise). Need to obtain a DCP time slot at least 6 months before submission, as potential RMS can be busy or booked up – some RMS may have longer waiting times.

Applicant chooses the CMSs – submission not necessary in all 29 MS

Can withdraw MAA from CMS that are causing difficulties without prejudice to applications in other MS, prior to Day 120.

If approved, approvals in all EU Member States (MS) at the same time If Serious Objections from CMS still exist at Day 210 (close of procedure) then risk of lengthy arbitration procedure and possible risk to approvals in EU Member States Well defined timescale throughout the procedure Well defined timescale throughout the procedure One tradename and MA holder must be used in all EU member states Different tradenames and MA holders in each MS possible If rejected, unable to subsequently go down the DCP / MRP route

The Organisation for Professionals in Regulatory Affairs

50