CRED 8 Presentations

01/07/2024

Post Brexit impact on regional considerations?

• UK(NI)is in scope for EU licensing procedures while UK(GB) is not • Derogation is up to 1 st Jan 2025 ( Brexit-related guidance for companies | European Medicines Agency (europa.eu))

• UK (GB)/EU regulation remains reasonably closely aligned with EU • MHRA • CP: no representation at CHMP or other Scientific Committee meetings • On behalf of UK(NI), MHRA is still able to comment on the EMA/RMS assessment report. • As a Concerned Member State (CMS) in MRP/DCP, MHRA can (for UKNI) raise questions however any Potential Serious Risks to Public Health (PSRPHs) do not have to be taken into account by the RMS and other CMSs. Note : MHRA evolving processes. Able to reference approvals of other major authorities / expanding on ACCESS (work-sharing consortium) and Project Orbis (for oncology products only)

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes: Recap

• To gain a good understanding of EU regional requirements • To be aware of some key considerations when preparing eCTD module 1 components for the EMA (for an EU centralised) and Reference Member State (for MRP/DCP)

• Electronic dossier format (eCTD) • Labelling and leaflets including readability testing • Translations • Pharmacovigilance Site Master File and Risk Management Plan • Environmental Risk Assessment • Orphan Drugs • Paediatric Investigational Plan • Manufacturing aspects – site inspections, QC testing and QP release

The Organisation for Professionals in Regulatory Affairs

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