CRED 8 Presentations

08/07/2024

MRP/DCP -Practical Tips Choice of RMS/Change of RMS – Brexit

● The UK formally left the European Union on 31 st January 2020 and had become a third country to the EU ● On 1 st February 2020, a transition period started which ended on 31 st December 2020 Impact on MRP/DCPs: ● CMDh stopped all ongoing regulatory procedures in which the UK is a RMS, except where the product is critical in a CMS ● RMS switches were carried out on all completed procedures where UK were the RMS ● Considerations for ongoing/new procedures: EU law requires that marketing authorization holders are established in the EU (or EEA) Some activities must be performed in the EU (or EEA), e.g. pharmacovigilance, manufacture, QP release: ● All Pharmaceutical companies need to consider Brexit as part of their strategy for new and ongoing MRP’s & DCP’s

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

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MRP/DCP - Practical Tips NI Protocol and Windsor Framework

NI Protocol: NI Protocol was implemented to avoid having a hard border between NI and Republic Of Ireland. There are some specific considerations for MR/DC Procedures: ● UK was automatically replaced with UK(NI) in existing procedures at the end of the transition period in January 2021 ● UK(NI) can be voluntarily included in any new MRPs and DCPs as a CMS country ● NI can perform batch release control ● UK(NI) can not be a RMS or act as a reference product

Impact of MRP/DCPs on UK national procedures: International Recognition Procedure (IRP)

● Applicants can use procedure to obtain an accelerated review and approval of a UK MA [PL] ● Specific guidance provided by the MHRA on how to manage UK(NI) and UK licences within NI. Current NI protocol to be replaced with Windsor Framework in January 2025. From which date, a PL and PLNI can not be held simultaneously

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

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