UK and EU pharmacovigilance requirements have continued to diverge following Brexit. Discover what has changed in 2026 for QPPVs, ICSRs, PSURs, PSMFs, safety referrals and MAHs managing UK and EU portfolios. 

UK vs EU Pharmacovigilance After Brexit: What Has Changed in 2026? 

Brexit did not simply create two separate regulatory systems for medicines.

It created two evolving pharmacovigilance frameworks that remain closely aligned in many areas but are no longer identical.

For pharmaceutical companies holding both UK and EU marketing authorisations, this creates an increasingly important operational question:

Can one pharmacovigilance system still support both markets — or does Brexit now require genuinely separate UK and EU processes?

The answer in 2026 is nuanced.

The fundamental principles of Good Pharmacovigilance Practice remain broadly aligned, but differences have emerged across individual case safety reporting, PSURs, safety referrals, QPPV arrangements, PSMFs, databases, risk management and regulatory submissions.

The position has become even more complex following implementation of the Windsor Framework arrangements from 1 January 2025 and further changes affecting UK pharmacovigilance requirements in 2026.

For MAHs operating across both markets, understanding these differences is no longer simply a compliance exercise.

It is becoming a key part of PV operating model design, inspection readiness and lifecycle management.

What changed after Brexit?

Before Brexit, the UK was part of the EU pharmacovigilance network.

UK MAHs operated within the EU regulatory framework and interacted with systems such as:

• EMA
• EudraVigilance
• PRAC
• EU PSUR single assessment
• EU safety referral procedures
• EU Good Pharmacovigilance Practice

Following the end of the Brexit transition period, the UK established its own pharmacovigilance framework under the Human Medicines Regulations 2012, while retaining many principles derived from EU GVP.

The MHRA now has responsibility for pharmacovigilance across the UK.

At the same time, Northern Ireland has had a particularly complex regulatory position because of the post-Brexit arrangements.

From 1 January 2025, medicines in the UK are licensed by the MHRA, with specific Category 1 and Category 2 arrangements determining how certain EU-derived PV requirements apply.

The result is a system that can be summarised as:

UK PV ≠ EU PV

but also:

UK PV remains closely connected to EU PV.

The 2026 UK pharmacovigilance landscape

The MHRA's current guidance, updated in August 2026, confirms that UK MAHs must submit pharmacovigilance information to the MHRA, including:

• UK and non-UK ICSRs
• PSURs
• Risk Management Plans
• PASS protocols and final reports

The MHRA assesses these using UK regulatory requirements and UK clinical practice.

However, there are additional distinctions depending on the type of UK authorisation.

Category 1

Category 1 products include medicines that were previously authorised through the EU centralised procedure and subsequently transitioned into the UK system.

These products follow UK pharmacovigilance requirements under the Human Medicines Regulations and Schedule 12A.

Category 2

Category 2 products are subject to additional provisions derived from EU Commission Implementing Regulation 520/2012.

This distinction has become particularly important in 2026 because amendments to the EU regulation took effect on 12 February 2026.

The MHRA has acknowledged that UK legislation is not currently fully aligned with the amended EU regulation and has issued interim guidance for affected MAHs.

For companies operating both UK and EU portfolios, this is an important reminder:

The UK's regulatory framework can continue to interact with EU requirements even though the UK operates an independent PV system.

1. QPPV requirements — similar principles, different operating models

One of the most important areas for MAHs is the Qualified Person Responsible for Pharmacovigilance.

For UK-authorised medicines, the MAH must have a QPPV who resides and operates in either the UK or EU/EEA.

If the UK QPPV is located in the EU/EEA, a UK national contact person for pharmacovigilance must also be appointed.

This creates flexibility for international companies.

A single suitably qualified QPPV may therefore support both UK and EU activities, provided the applicable legal and operational requirements are met.

However, the EU system independently requires its own EU/EEA pharmacovigilance arrangements.

For companies with UK and EU authorisations, this means the organisational model needs to clearly define:

• QPPV responsibilities
• UK national contact responsibilities
• EU/EEA responsibilities
• escalation pathways
• oversight of UK-specific safety information
• inspection readiness

The practical lesson is that one global PV system can still support both markets, but governance needs to reflect the different legal frameworks.

2. PSMF — one global system, but UK accessibility matters

The UK continues to require a Pharmacovigilance System Master File (PSMF) for UK-authorised products.

The UK PSMF must describe the pharmacovigilance system supporting UK products and must be electronically accessible from a location in the UK.

The MHRA can request access during inspection or assessment.

The PSMF should also accurately reflect the global PV system and the availability of safety information.

For multinational companies, this creates an important distinction from the EU model.

A company may operate a common global PV system and maintain integrated documentation, but it must ensure that the UK PSMF requirements are independently satisfied.

This makes PSMF governance particularly important where a company has:

• one global safety database
• one global QPPV
• EU and UK MAHs
• multiple affiliates
• outsourced PV activities

3. ICSR reporting — separate reporting channels are now essential

Individual Case Safety Reports are another major area of divergence.

UK MAHs must submit relevant UK ICSRs and serious non-UK ICSRs directly to the MHRA through the MHRA reporting infrastructure.

The standard reporting timelines remain:

• 15 days for serious cases
• 90 days for non-serious cases

The EU operates through EudraVigilance, which facilitates electronic exchange of ICSRs between EMA, national competent authorities and MAHs across the EEA.

Therefore, companies operating in both jurisdictions need to ensure that their safety database and case-processing workflows can correctly determine:

Which cases need to go to MHRA?

Which cases need to go to EudraVigilance?

Which cases need to go to both?

This is particularly important for companies with overlapping UK and EU licences.

4. The Windsor Framework adds another layer of complexity

Northern Ireland deserves particular attention.

Following the implementation of the Windsor Framework arrangements, UK medicines are now licensed by the MHRA, but pharmacovigilance requirements can differ according to product category.

For Category 1 products with an equivalent EU/EEA licence, certain EU reporting obligations remain relevant.

For example, where the same active ingredient has an EU/EEA licence, serious UK and other-country reports may need to be submitted to EMA, alongside relevant Northern Ireland non-serious cases.

This means PV teams should not assume:

UK licence = MHRA reporting only

The correct reporting pathway depends on the licence category, product status and EU authorisation position.

5. PSURs — similar reports, separate regulatory processes

PSUR management is another area where Brexit created additional work.

In the EU, MAHs generally prepare a single PSUR for products containing the same active substance, covering relevant indications, routes, dosage forms and regimens.

The EU uses the EURD list to coordinate PSUR submission dates and enable EU-level single assessment.

The UK also requires PSURs for UK-authorised products, subject to applicable exemptions and conditions.

However, UK PSURs submitted after the end of the Brexit transition period require a separate UK submission.

The EU PSUR can generally form the basis of the UK submission, but UK-specific information or responses may need to be incorporated where relevant.

This creates a practical opportunity for companies:

One core global PSUR can often support both regions — but the submission and regulatory assessment processes must be managed separately.

6. EU safety referrals no longer automatically apply to every UK product

Another important change concerns EU safety referrals.

For Category 2 products and Northern Ireland MAs, relevant EU pharmacovigilance referrals and PSUR single assessments continue to apply, subject to the applicable UK arrangements.

For Category 1 products, EU referrals no longer have the same legal status in the UK.

However, the MHRA expects MAHs to keep UK authorisations up to date with current scientific knowledge and to consider relevant EU outcomes when assessing whether UK regulatory action is needed.

This creates a subtle but important distinction:

An EU regulatory outcome may be legally binding in the EU without automatically being legally binding for a Category 1 UK authorisation.

PV and regulatory teams therefore need a documented process for:

1. monitoring EU safety developments;
2. assessing relevance to UK products;
3. determining whether UK action is required; and
4. submitting the appropriate UK variation or regulatory notification where necessary.

7. Risk Management Plans are increasingly market-specific

Risk Management Plans remain a central component of pharmacovigilance in both jurisdictions.

However, UK MAHs need to ensure that their RMP arrangements satisfy UK requirements and take account of UK-specific regulatory expectations.

For multinational products, this means that the global safety strategy can remain integrated, while:

• UK-specific risks
• UK epidemiology
• UK risk-minimisation measures
• UK regulatory commitments

may need to be reflected appropriately.

The key principle is:

Global PV strategy can be harmonised; regulatory implementation cannot always be.

8. Signal management — two regulatory environments

Signal detection remains a core responsibility of MAHs in both the UK and EU.

In the EU, EudraVigilance supports large-scale safety signal detection and assessment across the European regulatory network, with PRAC playing a central role in evaluating relevant signals.

In the UK, the MHRA is responsible for detecting and managing safety signals relating to UK products.

MAHs must also notify MHRA of relevant emerging safety issues and standalone signals according to UK requirements.

For global PV teams, the implication is straightforward:

Signal detection may be global, but signal management and regulatory escalation need market-specific oversight.

What has actually changed for pharma companies?

The biggest change is not necessarily the scientific methodology of pharmacovigilance.

It is the regulatory architecture around it.

Before Brexit, a company could often operate through a largely unified EU/UK PV framework.

In 2026, companies may need to manage:

The important point is that the two systems remain highly comparable but operationally distinct.

The 2026 development companies should not overlook

One of the most significant developments in 2026 is the amendment to EU Commission Implementing Regulation 520/2012, effective from 12 February 2026.

The MHRA has confirmed that this creates a temporary alignment issue because UK Schedule 12A has not yet fully reflected the amended EU requirements.

For Category 2 products, the amended EU provisions apply.

For Category 1 products where the MAH also has EU licences, MHRA has indicated that following the amended CIR can provide operational consistency across the UK and EU PV systems.

Category 1 products held by companies without an EU presence continue to follow the UK Schedule 12A requirements.

This is a particularly good example of why 2026 PV compliance cannot be managed using a static Brexit checklist.

Companies need active regulatory intelligence.

What should MAHs do now?

For companies holding both UK and EU licences, several practical actions are worth considering.

1. Map your licences

Create a portfolio-level view showing:

• EU MA status
• UK MA status
• Category 1 / Category 2
• Northern Ireland status
• EU centralised procedure status
• QPPV arrangements
• PSMF location
• reporting pathways

2. Review your ICSR reporting matrix

Confirm exactly which cases require:

• MHRA submission
• EudraVigilance submission
• both
• neither

Pay particular attention to serious/non-serious cases and Northern Ireland.

3. Review your PSUR strategy

Check whether your global PSUR process correctly captures:

• EU submission requirements
• UK submission requirements
• EURD timelines
• UK-specific data
• UK-specific regulatory requests

4. Reassess your QPPV and local contact model

Confirm:

• QPPV location
• UK national contact person
• EU/EEA PV responsibilities
• escalation routes
• deputy arrangements
• inspection readiness

5. Review your PSMF architecture

Ensure that your UK PSMF:

• remains current
• accurately describes the global PV system
• is accessible from the UK
• reflects outsourced activities
• contains appropriate UK-specific information

6. Update your SOPs and safety agreements

Brexit-related assumptions embedded in older SOPs and Safety Data Exchange Agreements may no longer be appropriate.

Review:

• case reporting
• literature monitoring
• signal management
• PSUR preparation
• safety referrals
• RMP updates
• regulatory intelligence
• escalation procedures

One global PV system — two regulatory interfaces

The good news is that companies do not necessarily need to create two completely independent pharmacovigilance organisations.

A single global PV system can continue to provide the foundation.

However, the regulatory interfaces need to be designed carefully.

A robust model can therefore be thought of as:

One global safety system

↓

Common case processing and signal detection

↓

UK-specific regulatory interface

EU-specific regulatory interface

This approach can help avoid unnecessary duplication while ensuring that market-specific legal obligations are respected.

What does this mean for smaller pharma and biotech companies?

For smaller companies, the challenge can be greater.

A company launching its first product in the UK and EU may need to establish:

• QPPV infrastructure
• UK PV arrangements
• EU PV arrangements
• PSMF architecture
• safety reporting capabilities
• PSUR processes
• signal management
• regulatory intelligence
• inspection readiness

The key is to design the PV system for both markets from the beginning, rather than building an EU system and attempting to retrofit UK requirements later.

This is particularly important for companies using outsourced PV providers.

The contractual scope should clearly define:

• UK responsibilities
• EU responsibilities
• case reporting
• regulatory authority communication
• PSUR ownership
• signal escalation
• inspection support
• PSMF responsibilities

Where is UK–EU pharmacovigilance heading?

Brexit has not resulted in two completely independent pharmacovigilance philosophies.

Instead, the UK and EU continue to operate systems that share many underlying principles while gradually developing different regulatory requirements.

The direction of travel is therefore likely to be:

Continued scientific alignment

but

increasingly distinct regulatory implementation.

For MAHs, the strategic priority is not to duplicate every PV activity.

It is to identify exactly where duplication is legally or operationally necessary — and where a harmonised global approach remains appropriate.

Final thought

Six years after the end of the Brexit transition period, UK and EU pharmacovigilance are no longer simply two versions of the same system.

They remain closely related, but the differences now matter.

The introduction of the Windsor Framework arrangements, the UK Category 1/Category 2 model and the 2026 changes to EU pharmacovigilance legislation demonstrate that the regulatory landscape continues to evolve.

For pharmaceutical and biotech companies, the key question is therefore no longer:

"Do we have a compliant EU PV system?"

It is:

"Is our global PV system correctly configured to meet the distinct UK and EU regulatory requirements?"

That distinction is increasingly important for MAHs, QPPVs, PV vendors, regulatory affairs teams and companies preparing for UK or EU launch.

Need support with UK & EU pharmacovigilance?

Regvista supports pharmaceutical and biotechnology companies with UK and EU pharmacovigilance strategy, QPPV and local PV arrangements, PSMF assessments, PSUR strategy, safety reporting, regulatory intelligence and post-authorisation compliance.

Whether you are launching a new product, transferring an MA, reviewing an outsourced PV model or assessing your post-Brexit compliance framework, Regvista can help identify the gaps between UK and EU requirements and develop a practical, inspection-ready approach.

At Regvista, we remain committed to support biopharmaceutical leaders navigating their transformative journey—bringing cutting-edge therapies to market faster and safer. Please feel free to contact us by submitting your enquiry to deployment@regvista.co.uk
02-Aug-26