MHRA Good Pharmacovigilance Practice Guidance: 2025 Updates for MAHs

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued critical updates to its MHRA Good Pharmacovigilance Practice guidance, effective from 1 January 2025. This updated post-Brexit UK pharmacovigilance guidance reinforces the country’s distinct standalone regulatory framework, introducing key compliance requirements for all Marketing Authorisation Holders (MAHs) operating in Great Britain and Northern Ireland.

Understanding these updates to UK Good Pharmacovigilance Practices (GVP) is essential for maintaining full compliance across your safety operations.

MHRA Good Pharmacovigilance Practice Guidance: Summary

This revised guidance impacts multiple pharmacovigilance areas, including periodic safety update reports (PSURs/PBRERs), risk management plans (RMPs), adverse drug reaction (ADR) reporting, the pharmacovigilance system master file (PSMF), and signal detection processes. Below, we explore the key changes and their implications.

View full guidance here

Act Now to Secure Compliance for 2025!

As your trusted partner in navigating regulatory change and driving drug safety excellence, whether you need support meeting UK standards or ensuring global pharmacovigilance compliance, PharSafer delivers compliant safety solutions not only in the UK but worldwide.

For any questions or assistance for how to best navigate these updates and their implications for your safety operations, please do not hesitate to contact our team.

Key Updates in MHRA Good Pharmacovigilance Practice Guidance:

1. Periodic Safety Update Reports (PSURs) & PBRERs

The Medicines and Healthcare products Regulatory Agency (MHRA) categorizes products into two distinct regulatory tracks:

• Category 1 Products (PLGB Licences): Products falling under the mandatory or optional scope of the EU Centrally Authorised Procedure that have transitioned to a PLGB licence (authorised in Great Britain only). These fall under UK PV requirements, making Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) mandatory for submission directly to the MHRA.

• Category 2 Products (PLNI Licences): Products authorised for Northern Ireland under PLNI licences. These remain aligned with EU PV requirements. PSURs do not need to be submitted to the MHRA unless the product is not authorised in the EU/not listed on the EURD list, or is imported under a parallel import.

• Data Lock Points (DLPs): MAHs must follow UK-specific Data Lock Points (DLPs) / EURD list schedules. If no national schedule is specified, a default MHRA timeline applies (6 months until 2 years on market, annually for the next 2 years, then every 3 years). Generic, well-established use, and herbal products remain exempt from PSUR submissions.

2. Risk Management Plans (RMPs) & Risk Minimisation Measures

The revised guidance emphasizes local context when drafting Risk Management Plans (RMPs):

• UK-Specific Focus: RMPs must incorporate tailored Risk minimisation measures specific to UK patient demographics and healthcare settings.

• Operational Divergence: Products authorised simultaneously in the UK and Europe may now require differing RMPs for the same active substance and indication. MAHs must account for this when planning global safety protocols.

3. Adverse Drug Reaction (ADR) Reporting & ICSR Submissions

Managing Adverse Drug Reaction (ADR) reporting requires adherence to clear submission windows and channels:

• Medical Literature Monitoring (MLM): The EMA literature service applies to Category 2 products. To avoid duplicate Individual Case Safety Reports (ICSRs), MAHs should only submit literature-based ICSRs to the MHRA for non-EMA-monitored active substances.

• 15-Day Timelines (Serious ICSRs): All serious ICSRs occurring inside or outside the UK must be submitted within 15 calendar days. Category 1 & 2 serious cases must also be transmitted to EudraVigilance.

• 90-Day Timelines (Non-Serious ICSRs): Non-serious ADRs occurring in the UK or EEA states must be submitted within 90 calendar days via direct MHRA Gateway channels (in ICH E2B R2/R3 formats).

4. Pharmacovigilance System Master File (PSMF), QPPV & NCP

Your system documentation standards must reflect the following operational controls:

• UK Accessibility: The Pharmacovigilance System Master File (PSMF) must be electronically accessible from a single UK-based location.

• QPPV & Nominated Contact Person (NCP): MAHs must maintain a Qualified Person for Pharmacovigilance (QPPV). If based outside the UK, a UK-based Nominated Contact Person (NCP) for PV must be registered. Any change to NCP details must be notified to the MHRA within 14 calendar days.

• PSMF Annex Updates: Annex A must detail delegated tasks; Annexes B, C, and H must list global authorisations; Annex F must capture UK and EMA reporting metrics for Category 2 products; Annex H must explicitly state product categorisation (Category 1 vs Category 2).

5. Pharmacovigilance Signal Detection and Management

• UK-Specific Signals: Pharmacovigilance signal detection and management processes must integrate MHRA-defined safety parameters to prioritize UK-specific public health risks.

• Proactive Engagement: MAHs are expected to collaborate actively with the MHRA on emerging safety signals and communicate risks transparently via national medicine portals.

Is Your Organisation Ready for the 2025 GVP Updates?

Meticulous preparation and system adjustments are necessary to distinguish between UK and EU regulatory obligations. PharSafer provides complete support to help you achieve audit-readiness:

• Leverage automated reporting platforms like RAPTAR to streamline ICSR and safety data delivery.

• Optimize your UK QPPV, NCP, and PSMF management through our specialized Pharmacovigilance Services.

• Align your UK RMPs and compliance frameworks with expert guidance from our Regulatory Strategy team.

• Explore our full suite of end-to-end PharSafer Services to safeguard your global product portfolio.

For guidance on implementing these updates within your safety operations, contact our specialist team today at enquiries@pharsafer.com.

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