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UK Pharmacovigilance Responsibilities Post-Brexit: What Pharma Companies Need to Know

As the UK regulatory environment continues to evolve following Brexit, pharmaceutical companies face critical decisions around how to structure their pharmacovigilance (PV) systems to meet Medicines and Healthcare products Regulatory Agency (MHRA)’s expectations.

For any Marketing Authorisation Holder (MAH) operating in the UK, understanding and implementing the correct PV framework is not only a matter of regulatory compliance but also an opportunity to streamline operations, manage costs, and align with broader business infrastructure.

What Has Changed Since Brexit?

Brexit formally separated the UK from the EU regulatory network requiring the UK to follow its own independent regulatory processes.

As part of this shift, MAHs must meet specific post-Brexit PV obligations, including:

  • Appointing a UK QPPV who resides and operates in the UK or the EU/EEA.
  • Maintaining a Pharmacovigilance System Master File (PSMF) that reflects UK-specific activities and is accessible in the UK.
  • If using an EU/EEA QPPV, appointing a UK National Contact Person for Pharmacovigilance to serve as the first point of contact for MHRA and ensure availability during UK business hours.

These requirements apply to all products authorised under UK licenses – including purely national UK licenses and those grandfathered from the EU Centralised Procedure.

Core UK PV Responsibilities for MAHs

MAHs with UK-authorised products must ensure their pharmacovigilance systems meet the MHRA’s expectations. Key responsibilities include:

  • Maintaining an up-to-date, UK-accessible PSMF
  • Ensuring 24/7 availability of a UK QPPV or EU QPPV with a UK contact person
  • Collecting and reporting adverse drug reactions (ADRs) within required timelines
  • Performing ongoing signal detection and safety evaluations
  • Submitting periodic safety reports (e.g. PSURs) as required
  • Developing and maintaining Risk Management Plans (RMPs), including UK-specific additional risk minimisation measures (aRMMs) where needed
  • Being inspection-ready, with systems and documentation that meet UK regulatory standards

These core obligations apply regardless of whether the PV system is UK-only or integrated with an EU framework.

Two Implementation Models for UK PV Compliance

1. Standalone UK PV System with a UK QPPV

This model involves establishing a dedicated UK pharmacovigilance system overseen by a UK-based QPPV. It’s particularly well-suited for companies focused exclusively on the UK market or operating with a distinct UK commercial strategy.

Benefits:

  • Cost-effective for UK-focused companies: If your business is limited to the UK, this model avoids the need to maintain alignment with EU PV systems, making it a leaner and more straightforward setup.
  • Simplified operations: Reduces complexity by eliminating coordination with EU-based teams or overlapping systems.

Considerations:

  • Limited scalability: For companies looking to expand into the EU, duplicating PV infrastructure across regions can increase long-term operational costs.
  • System maintenance overhead: Requires independent PSMF, SOPs, and safety data management aligned to MHRA requirements.

2. EU PV System with EU QPPV & UK National Contact Person

In this model, the EU QPPV maintains oversight of the pharmacovigilance system, while a UK-based National Contact Person for Pharmacovigilance ensures local availability and MHRA compliance.

Benefits:

  • Cost-efficient for multi-region businesses: This approach avoids building an entirely separate PV infrastructure for the UK, allowing companies to leverage their existing EU systems.
  • Centralised operations: Ideal for companies already operating across the EU, enabling consistent processes, technology platforms, and oversight.
  • Reduced duplication: Shared SOPs, databases, and reporting systems help minimise redundancy.

Considerations:

  • More complex for UK-only products: If your company is not active in the EU, maintaining an EU QPPV solely to meet MHRA requirements can introduce unnecessary cost and complexity.

Why This Matters – and How We Can Help

Choosing the right pharmacovigilance model for the UK post-Brexit is not just about regulatory compliance – it’s about ensuring your PV system aligns with your commercial footprint, infrastructure, and growth strategy. Whether your focus is solely on the UK, across the EU, or both, Integral Pharma Solutions offers a comprehensive suite of PV services designed to meet your needs efficiently and effectively.

At Integral Pharma Solutions, we provide:

  • A Full UK Pharmacovigilance System
    Including a UK-based Qualified Person for Pharmacovigilance (UK QPPV), a UK-specific Pharmacovigilance System Master File (PSMF), and full compliance with MHRA requirements.
  • A Full EU Pharmacovigilance System
    Including an EU-based QPPV, an EU-compliant PSMF, and integration with the broader EU regulatory environment.
  • UK National Contact Person for Pharmacovigilance
    For companies retaining an EU QPPV but requiring local representation in the UK, we provide a responsive, MHRA-facing contact to ensure continuous compliance.

Whether you are a UK-only MAH, a pan-European business, or preparing to scale across markets, we have the infrastructure and expertise to support your PV obligations — without unnecessary duplication, cost, or complexity.

Ready to align your PV strategy with your market focus?

Contact Integral Pharma Solutions today to learn how we can support your UK and EU pharmacovigilance needs with scalable, compliant, and cost-effective solutions.

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