Post-Brexit regulatory changes transformed the United Kingdom into an independent pharmacovigilance ecosystem. The shift created separate legal obligations, standalone reporting systems, and UK-specific safety governance. Marketing Authorisation Holders (MAHs) now manage two different regulatory pathways, i.e, EU/EEA and UK, as distinct jurisdictions. The UK framework remains science-aligned with the EU model, yet the processes, reporting tools, and legal requirements follow MHRA-defined rules.
This guide sets out the complete picture so that MAHs understand every requirement needed for compliance.
UK’s Independent PV Framework
The MHRA assumed full responsibility for post-marketing safety surveillance after Brexit. The new framework reinforces signal detection pathways, case reporting standards, and oversight of risk minimisation activities. The system retains the scientific foundation of the EU model but follows a UK-driven governance approach.
Key developments include:
- A fully independent vigilance system, the MHRA’s “SafetyConnect” programme, created to modernise signal monitoring.
- A clear separation of UK PSUR, RMP and ICSRs from EU submissions.
- Distinct roles such as the UK Qualified Person for Pharmacovigilance (UK QPPV) and a GB-based PV system.
Case Reporting Requirements (ICSR Submissions)
The MHRA uses the MHRA Gateway and ICSR Submissions Portal for case reporting. MAHs must submit:
- Serious ICSRs from the UK within 15 days
- Non-serious ICSRs within 90 days
- Reports received globally for UK-authorised products
The MHRA no longer accepts ICSR submissions through EudraVigilance. Each submission requires correct MedDRA coding, structured XML formatting, and validation rules aligned with MHRA technical specifications.
Post-Brexit PSUR and RMP Obligations
The UK now assesses PSURs (Periodic Safety Update Reports) independently. Submission requirements depend on MHRA-published PSUR schedules. MAHs must:
- Submit PSURs directly to the MHRA via the portal
- Address UK-specific safety concerns
- Provide evidence of benefit-risk evaluation aligned with national priorities
For Risk Management Plans (RMPs), the MHRA expects UK-tailored safety specifications, safety concerns, and risk minimisation measures. EU RMPs no longer automatically apply to UK authorisations.
Signal Detection and Safety Monitoring
The MHRA strengthened its internal intelligence capabilities through SafetyConnect and real-world evidence channels. MAHs must maintain:
- Robust signal detection procedures
- Clear processes for evaluation and escalation
- Timely reporting of emerging issues
The MHRA reviews safety signals independently and can request targeted analyses, epidemiological studies, or updates to product information.
Pharmacovigilance Inspections
The MHRA conducts both routine and triggered PV inspections. Inspectors expect:
- A fully operational UK PSMF
- Evidence of proper oversight by the UK QPPV
- Accurate reconciliation of cases, literature monitoring, and vendor oversight
- Implementation of CAPAs without delay
Inspections are now more data-driven, focusing heavily on system performance and real-world safety outcomes.
Northern Ireland: Special Regulatory Position
Northern Ireland follows a unique route due to the Windsor Framework, which introduced the concept of UK-only packs. For pharmacovigilance:
- UK PV requirements apply to Northern Ireland
- The EU/EEA PV system no longer governs medicines supplied through the UK route
- MAHs must align reporting with MHRA rules for all GB and NI products
This arrangement simplifies earlier complexities under the Northern Ireland Protocol.
Digital Transformation and Future Trends in Brexit Pharmacovigilance in the UK
The UK plans to expand digital surveillance and patient-centric reporting through:
- Artificial intelligence-based signal evaluation
- Patient-focused digital reporting tools
- Integration of real-world evidence from NHS datasets
- Faster review cycles to support global safety harmonisation
The MHRA aims to build a responsive, innovation-ready pharmacovigilance ecosystem that supports advanced therapies, decentralised trials, and precision medicine.
Conclusion
Post-Brexit pharmacovigilance Services in UK reshaped regulatory responsibilities for MAHs. The framework is stable, predictable, and built around national oversight. Companies operating in the UK must invest in their UK QPPV function, maintain a strong UK PSMF, meet local ICSR timelines, and manage independent PSUR and RMP submissions. The MHRA’s shift toward digital intelligence will drive the next era of safety governance, and early adaptation will strengthen compliance and operational efficiency.
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