Spring Intro 2023

03/03/2023

● Clock stop up to 6 months – can be extended with agreement from RMS ● RMS may review draft response document ● Applicant submits response document to RMS and all CMS and procedure restarts (Day 106) ● By Day 120: RMS updates preliminary AR to produce draft AR, SmPC, PIL and Label ● RMS may close procedure if consensus is reached DCP

The Organisation for Professionals in Regulatory Affairs

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DCP

If consensus not reached in Step I, RMS sends draft AR, SmPC, PIL and label to CMSs on Day 120 ● By Day 145: CMS send final comments ● Day 150: RMS may close procedure if consensus is reached If no consensus at Day 150: outstanding points are sent to applicant ● Day 160: Applicant submits further Responses to Outstanding Points ● Day 180: RMS prepares a report for discussion at CMDh ● Day 195: Break out meeting ● Day 210: Closure of procedure or referral to CMDh This 90 day clock does not stop

The Organisation for Professionals in Regulatory Affairs

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