Spring Intro 2023

03/03/2023

Responding to Questions

Potential Serious Risk to Public Health and Referrals ● In all MAAs PSRPH issues are raised early on

● Areas deemed to be PSRPH must be given priority by the Applicant – Efficacy; Safety; Quality; Overall risk-benefit; Product information (as defined in (Guideline 2006/C 133/05) ● In both DCP and MRP the Applicant has several opportunities to allay concerns – The earlier PSRPH are addressed, the better ● Inadequate responses at Day 210 (DCP) means 60-day referral to CMDh ● Details of CMDh referrals (timetable, process and outcomes) are given on Heads of Agency web site (http://www.hma.eu/26.html)

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Responding to Questions

● In DCP it is possible to end the procedure at: Day 105, 120, 150, 210 ● Opportunities to respond (DCP) therefore arise between these intervals; [NB. there’s a clock stop between day 105-106] ● MRP – best time to respond is between Day 30 and 40 and after Day 55 ● Best efforts need to be made to avoid getting to Day 210 (DCP) or Day 90 (MRP) with issues outstanding ● Key experts need to be in place to compile these responses

The Organisation for Professionals in Regulatory Affairs

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