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
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