CRED Managing Variations Effectively

Submission due date

Validation

Procedure

Rapp involvement

IA

No

No

Notification in 30 days Notification in 30 days 1 RSI 60 day default timetable

No

IB

Only when linguistic review

Yes

Yes

II

Weekly / monthly submission due dates monthly submission due dates

Yes

Yes

II- Extension of Indication

Yes

90 days default timetable

Yes (co-Rapp on case by case basis)

78 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations