UK-Specific Adaptations to EU Good Pharmacovigilance Practices

1. Regulatory context after EU exit

After the end of the EU transition period, the United Kingdom retained the EU guidance on Good Pharmacovigilance Practices (GVP) as a reference framework. However, to ensure legal operability under UK medicines legislation, specific exceptions and modifications apply to UK marketing authorisation holders (MAHs) and to the Medicines and Healthcare products Regulatory Agency (MHRA). These adaptations ensure continuity of pharmacovigilance while reflecting the UK’s standalone regulatory system. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

2. Continued applicability of EU GVP modules

In principle, the structure and content of EU GVP modules continue to apply in the UK. UK MAHs are expected to follow the same scientific and operational standards for:

• Adverse reaction reporting
• Signal management
• Risk management systems
• Pharmacovigilance quality systems

Unless explicitly modified, references to EU GVP should be interpreted as applying in a UK context. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

3. Terminology and institutional substitutions

One of the key categories of modification concerns terminology. In applying EU GVP in the UK:

• References to the European Medicines Agency (EMA) are read as references to the MHRA, where relevant
• References to EU institutions, committees, or procedures are interpreted as the corresponding UK regulatory functions
• Obligations addressed to EU member states are understood as obligations within the UK system

These substitutions ensure that regulatory responsibilities are clearly assigned within the UK framework. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

4. UK-specific reporting systems and timelines

EU GVP provisions referring to EU-wide systems are modified to reflect UK-only reporting arrangements. In particular:

• References to EudraVigilance are replaced by UK adverse drug reaction reporting requirements, including reporting to the MHRA
• Reporting timelines and formats continue to align with international standards, but submissions are made through UK-designated systems

UK MAHs must therefore ensure their pharmacovigilance systems are configured for separate UK reporting, even if EU systems are also maintained. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

5. Qualified Person for Pharmacovigilance (QPPV)

The guidance clarifies that obligations relating to the Qualified Person for Pharmacovigilance (QPPV) apply in a UK context:

• UK MAHs must ensure continuous availability of a QPPV responsible for UK pharmacovigilance activities
• Where EU GVP refers to EU-based oversight or coordination, this is adapted to UK national oversight by the MHRA

This ensures accountability for pharmacovigilance within the UK regulatory environment. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

6. Risk management plans and post-authorisation measures

EU GVP requirements relating to risk management plans (RMPs) and post-authorisation safety measures continue to apply, but with modifications such that:

• Submissions, assessments, and approvals are conducted by the MHRA, not EU bodies
• UK-specific safety concerns or conditions may be imposed independently of EU decisions

UK MAHs must therefore track and manage UK-specific pharmacovigilance commitments, even where products are authorised in multiple jurisdictions. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA

7. Practical implications for UK MAHs

From a compliance perspective, the exceptions and modifications mean that UK MAHs should:

• Review EU GVP modules alongside the UK modification document
• Map EU references to their UK equivalents in internal procedures
• Ensure clear separation, where necessary, between EU and UK pharmacovigilance reporting and governance

Early alignment of pharmacovigilance systems with UK-specific requirements reduces the risk of non-compliance during MHRA inspections. Source: Exceptions and modifications to EU GVP that apply to UK MAHs and the MHRA