CRED 8 Presentations

08/07/2024

Registration Strategy Mutual Recognition Procedure

• Existing national licence required

Day 0

• RMS manages timetable and leads assessment

Day 30 – CMS Questions Day 40 – Applicant Responses Day 55 – CMS Questions Day 60 – Either Procedure concludes or Further round of questions Day 75 CMS Questions

• RMS issues assessment report

• Submission into one or more CMSs

• CMSs asked to Mutually Recognise RMS decision

• 90 day timetable with no clockstop.

Day 80 – Applicant Responses Day 85 – CMS final position

• Procedure concludes at Day 90

• National phase follows procedure conclusion • National HAs grant licenses on a local basis

Day 90 Procedure Concludes

MA Grant - 1 month > 1 year depending on the Member State

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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After Day 90

Day 90 = successful conclusion of process if no issues of PSRPH Each MS must agree translations of SmPC, PIL, label before issuing National licence Should take 30 days but many Member States take significantly longer than this

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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