CRED ERP 25

01/07/2025

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

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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. NI protocol was replaced with Windsor Framework in January 2025. From which date, a PL and PLNI can not be held simultaneously

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