CRED 8 Presentations

01/07/2024

Managing the Procedure (Details in back-ups)

The Organisation for Professionals in Regulatory Affairs

15

Standard Timeline – “210” day Assessment

Months 1 2 3 4 5 6 7 8 9 10111213141516

Assessment phase 1

Assessment phase 2

Assessment phase 3

Linguistic review and Decision making

Validation

30 days

Clock stop^

Clockstop for LoQ - 3 months*

~20 days

120 days

60 days

By Day 277 EC Decision

Day 210 CHMP Opinion

Procedure Start

Day 80 Preliminary ARs

Day 121 LoQ Response

Day 120 LoQ

Day180 LoOI OR CHMP opinion

Day 181 LoOI response **

Submit

GMP and potential GLP, GCP INSPECTIONS

Possible oral explanation /final label updates

* Clockstop can be 1 -3 months under standard assessment. An extension to 6 months can also be requested ^ The usual clockstop to address the LoOI is 30 days (up to 3 months); possible that an oral explanation could be held during this period  Possible to do “immediate response” if agreed with EMA

The Organisation for Professionals in Regulatory Affairs

16