CRED Managing Variations Effectively

Referral to CMDh

CMS Sends negative position and reasons for PSRPH RMS formally initiates referral

Day 0

Procedure starts RMS proposes LoQ

Day 5

CMS Comment on LoQ

Day 8

RMS circulates final LoQ

Day 10

LoQ sent to MAH

Approx Day 20

CMDh -1- LoQ tabled for info

Up to Day 25

MAH sends response document

Around Day 35

RMS circulates updated AR

Around Day 43

CMS state view on Response and AR

CMDh - 2- Scientific Discussion, possible hearing and decision

Around Day 50

Around Day 55

RMS circulates final proposal for agreement

121

By Day 60

CMDh Members confirm agreement or disagreementNo consensus - CHMP Referral