The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that apply to UK Marketing Authorisation Holders (MAHs) following Brexit. This guidance outlines key modifications and exceptions to the EU Good Pharmacovigilance Practices (GVP), ensuring regulatory compliance under UK law.
The latest version, published on 7 February 2025, incorporates significant changes to align with UK legislation, including adjustments following the Windsor Framework, which came into effect on 1 January 2025. These changes redefine pharmacovigilance obligations for medicinal products authorised in the UK.
Pharmacovigilance refers to the monitoring, assessment, and prevention of adverse effects of medicinal products.
GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU. GVP applies to MAHs, the European Medicines Agency (“the Agency”), the licensing authority and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level
The Windsor Framework replaces the previous Northern Ireland Protocol, allowing novel medicines to be licensed directly under the UK-wide MHRA process, rather than following the EU Centralised Procedure.
UKMA (UK) Category 1 products must comply with UK-specific pharmacovigilance regulations.
UKMA (UK) Category 2 products follow EU pharmacovigilance laws, requiring adherence to the Commission Implementing Regulation (EU) No. 520/2012.
Overview of UK-Specific Pharmacovigilance Modifications
While the UK continues to follow the EU GVP as a baseline, several key modifications have been made:
1. Qualified Person for Pharmacovigilance (QPPV)
The QPPV for UK-authorised products can reside and operate anywhere in the UK or EU/EEA.
If the QPPV is located outside the UK, a UK-based national contact person for pharmacovigilance must be appointed.
2. Pharmacovigilance System Master File (PSMF)
The PSMF for UK-authorised products must be electronically accessible within the UK.
For Category 2 products, the PSMF must be available at an EU location.
UK-specific variations in reporting obligations and pharmacovigilance audits are now in effect.
3. Risk Management and Adverse Reaction Reporting
UK MAHs must report adverse drug reactions (ADRs) to the MHRA, following UK timelines.
Additional risk minimisation measures (RMMs) may be required for UK-specific product authorisations.
4. Periodic Safety Update Reports (PSURs)
PSURs for UK-authorised medicines follow UK submission timelines.
For Category 2 products, EU PSUR submission rules continue to apply.
5. Pharmacovigilance Inspections
The MHRA will conduct independent pharmacovigilance inspections of UK MAHs.
Inspections of Category 2 products will be shared with the European Medicines Agency (EMA) where applicable.
GVP Modules Impacted by UK Modifications
The following GVP modules have undergone specific changes:
GVP Module | UK-Specific Modification |
GVP Module I | UK-specific pharmacovigilance quality systems introduced. |
GVP Module II | UK PSMF location requirements modified. |
GVP Module III | MHRA-defined pharmacovigilance inspection process. |
GVP Module V | UK-specific risk management system updates. |
GVP Module VI | UK adverse reaction reporting requirements. |
GVP Module IX | UK-defined signal management protocols. |
GVP Module XV | UK-tailored safety communication strategies. |
Product- and Population-Specific Considerations
Vaccines, biological products, and pediatric medicines have additional UK-specific pharmacovigilance requirements.
Traditional herbal and homeopathic medicinal products now require a modified Pharmacovigilance System Master File (PSMF) in the UK.
The complete document is available for review and download on the UK Government website: 🔗 UK MHRA Pharmacovigilance Guidance
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