Pharmacovigilance After the Windsor Framework: What MAHs Need to Know in 2025

The Windsor Framework, implemented on 1 January 2025, introduces important regulatory changes for pharmacovigilance (PV) across the UK. While Great Britain (GB) follows UK PV legislation, Northern Ireland (NI) continues to align with EU GVP requirements. For Marketing Authorisation Holders (MAHs), this means managing dual systems — and adapting processes to stay compliant.

This blog explores the pharmacovigilance implications of the Windsor Framework, referencing MHRA’s official guidance and the updated "Exceptions and Modifications to the EU Guidance on GVP" issued in January 2025.

The Regulatory Split: GB vs NI

Under the Windsor Framework:

• Great Britain (England, Scotland, and Wales) follows UK pharmacovigilance legislation, enforced by the MHRA.

• Northern Ireland, however, continues to follow EU pharmacovigilance requirements under the EU GVP modules.

This means MAHs should apply EU pharmacovigilance standards to products marketed in Northern Ireland, in line with EU Member State requirements. Importantly, the regulatory obligations differ depending on the product's classification as Category 1 or Category 2:

• Category 1 products: Centrally authorised (CAP) or NI-specific EU-authorised products. These remain subject to EU rules.

• Category 2 products: GB-authorised products permitted to be marketed in NI under the Windsor Framework. These are subject to UK rules.

Key PV Implications for MAHs

1. Dual Reporting Obligations

For adverse events that occur in Northern Ireland, MAHs must:

• Submit expedited ICSRs to both the MHRA and EudraVigilance, depending on product category.

• Maintain clear procedures to identify and categorise NI cases separately from GB cases.

2. ICSR Submission Timelines and Systems

• Category 1 products:

  • Serious ICSRs: 15 calendar days

  • Non-serious ICSRs: 90 calendar days

  • Submit to EudraVigilance

• Category 2 products:

  • Submit serious ICSRs to both MHRA and EMA (via EudraVigilance) within 15 days

  • Submit non-serious ICSRs from NI or EEA to EMA within 90 days

  • Submit all ICSRs to MHRA in accordance with UK requirements

MHRA guidance clarifies that duplicate reporting is not generally required but may apply in certain cases (e.g. when the case involves two different products with distinct authorisations). MAHs should also avoid resubmitting NI ICSRs received from MHRA, as these are already forwarded to EMA. Robust, risk-based procedures should guide submission decisions.

3. PV System Master File (PSMF) and QPPV Location

• MAHs are expected to maintain UK and EU PSMFs where appropriate.

• A UK QPPV must be appointed for UK-authorised products; if based outside the UK, a UK National Contact Person for Pharmacovigilance (NCPPV) is required.

• EU QPPV requirements still apply for NI Category 1 products.

For more detailed information please see MHRA ‘Guidance Pharmacovigilance following agreement of the Windsor Framework’.

GVP Modifications: January 2025 Update

The MHRA's updated guidance on exceptions and modifications to EU GVP introduces:

• Clarified deviations from EU GVP Modules I, II, IV, VI, and XV.

• Defined UK-specific expectations for risk management plans, signal detection, and aggregate reporting.

• Reinforces the need for procedural alignment across both EU and UK systems where dual compliance is required.

These modifications particularly affect MAHs with products distributed in both GB and NI, and may necessitate updates to SOPs, PV agreements, and training documentation.

Practical Considerations for MAHs

• Review product portfolios to categorise products appropriately.

• Ensure PVAs cover NI obligations distinctly, especially where dual submissions are needed.

• Adjust SOPs and internal training to reflect updated requirements under the Windsor Framework.

• Consider automation tools for ICSR triage and reporting rules based on product category and geography.

Conclusion

The Windsor Framework presents a complex but navigable regulatory landscape for pharmacovigilance. For MAHs operating in both Great Britain and Northern Ireland, success lies in proactively adapting systems and processes to ensure compliance with both UK and EU requirements.

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If you need support navigating your pharmacovigilance obligations under the Windsor Framework, or aligning your safety systems across GB and NI, feel free to contact me at amanda@drugsafetyservices.co.uk or connect with me on LinkedIn.