The implementation of the Windsor Framework on January 1, 2025, marked a significant regulatory milestone for the UK pharmaceutical industry, particularly in pharmacovigilance (PV). For the first time, the Medicines and Healthcare Products Regulatory Agency (MHRA) assumed sole authority for licensing all human medicines across the UK, including Northern Ireland (NI).
In this article, we unpack these regulatory changes on Marketing Authorization Holders (MAHs) and offer recommendations to help organizations achieve compliance, mitigate risk, and ensure business continuity in a transformed regulatory environment.
Get Product Categorization Right Or Risk Compliance Consequences
Understanding how your products are categorized under the Windsor Framework is the first step to determining your PV obligations. The framework introduces two categories with distinct legislative requirements and operational impacts.
- Category 1 Products: These include medicines previously authorized through the European Union (EU) Centralized Procedure (CAP) or those within its mandatory or optional scope, now licensed UK-wide by MHRA. These are governed by Part 11 and Schedule 12A of the Human Medicines Regulations (HMRs).
- Category 2 Products: All other products, including those previously authorized through national routes, Mutual Recognition Procedure (MRP), or Decentralized Procedure (DCP), governed by Part 11 of the HMRs and Commission Implementing Regulation (EU) No 520/2012 (CIR).
Correct classification is essential to avoid misaligned reporting, non-compliance, or regulatory intervention. MAHs should reference the MHRA’s Category 1 product list and consult regulatory teams for confirmation.
Aligning with Individual Case Safety Report Reporting Rules
Individual Case Safety Report (ICSR) submission processes have been harmonized across the UK, and there are subtle differences based on product categorization and market authorization status. All MAHs must ensure reporting to both MHRA and EMA as appropriate.
Key Requirements:
- All MAHs: Submit UK ICSRs and serious third-country ICSRs to MHRA:
- Serious reports: within 15 calendar days
- Non-serious reports: within 90 calendar days
- Use country code XI for Northern Ireland (NI)-originating cases.
EMA Reporting Obligations
| Product Category | EMA Reporting Requirements |
| Category 1 – UK-only license | No EMA reporting |
| Category 1 – UK & EU license | Submit serious ICSRs (15 days) & NI non-serious ICSRs |
| Category 2 (all licenses) | Submit serious ICSRs (15 days) & NI/European Economic Area (EEA) non-serious ICSRs (90 days) |
Note: Avoid duplication. MAHs should not resubmit NI ICSRs received from MHRA, as MHRA forwards them to EMA.
PSUR Submissions: Two Paths, One Compliance Goal
Periodic Safety Update Reports (PSURs) help authorities assess a product’s risk-benefit profile over time. Under the Windsor Framework, submission routes and obligations differ between Category 1 and 2 products, depending on the product’s license scope.
Submission Processes:
- Category 1 Products:
- Submit via MHRA PSUR Portal
- If also EU-licensed, submit to EU PSUR Repository
- Category 2 & NI MAs:
- Submit via EU PSUR Repository only; MHRA will access unless requested otherwise.
The MHRA may impose UK-specific PSUR submission requirements. Follow the EU Reference Date (EURD) list for timelines in their absence.
Coordinating PASS Submissions for Compliance and Oversight
Post-authorization Safety Studies (PASS) are essential for monitoring long-term product safety. Under the Windsor Framework, submission responsibilities are determined by product category and study scope.
Submission Requirements:
- Category 1: Submit draft protocols, amendments, and final reports to MHRA.
- Category 2 & NI MAs: Submit to EMA Pharmacovigilance Risk Assessment Committee and MHRA, unless MHRA requests a UK-only study.
PV professionals should ensure their internal systems accommodate dual submission workflows and maintain rigorous inspection documentation.
EU Safety Referrals: Know Your Category and Responsibilities
The Windsor Framework shifts responsibility for implementing EU safety referrals depending on product classification. PV teams must remain vigilant in regulatory monitoring and decision-making.
- Category 1: No legal requirement to implement EU outcomes, but MAHs must keep authorizations current with scientific knowledge. Evaluate EU decisions within the context of the UK license.
- Category 2 & NI MAs: Must implement EU pharmacovigilance referrals (e.g., Article 31, urgent union procedures) per EU timelines. MHRA may issue UK-specific instructions within 14 days if outcomes diverge.
Be Prepared for UK-Driven Decisions
Beyond EU referrals, MHRA may conduct independent safety reviews for products licensed in the UK. These reviews are triggered by signals, concerns, or risk minimization needs, and may result in regulatory actions. When such actions conflict with MRP/DCP procedures, MAHs must withdraw from mutual recognition and hold standalone UK-wide MAs. This reinforces the importance of proactive engagement with MHRA updates.
QPPV and PSMF: New Rules, Consistent Expectations
The Windsor Framework introduces distinct legal bases for Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF), depending on the product category. However, operational requirements are unchanged.
- QPPV Requirements:
-
- Category 1: Governed by UK Human Medicines Regulations (HMR) Schedule 12A.
- Category 2: Governed by Commission Implementing Regulation (CIR) Article 10.
- If QPPV is EU/EEA-based, appoint a UK National Contact Person.
- UK PSMF Requirements: A UK PSMF is required for all UK marketing authorizations.
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- Category 1: HMR Schedule 12A Part I
- Category 2: CIR Chapter I
UK QPPV Summary
| Product Category | Territory | UK QPPV | EU-QPPV | EU-QPPV |
| Can reside in EU/EEA or UK | Must reside in EU/EEA | Can reside in UK or EU/EEA | ||
| Category 1 | UK only | Yes | No | No |
| Category 1 | UK & EU license | Yes | Yes | No |
| Category 2 | UK only | Yes | Subject to EU Directive 2022/642(13) | Subject to EU Directive 2022/642 |
| Category 2 | UK&EU license | Yes | Yes | No |
XEVMPD Reporting: Broader Duties for Category 2 Products
Notifying product data to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is mandatory, but the scope differs by category.
- Category 1: Continue existing notification requirements.
- Category 2: Notify MHRA and submit UK QPPV and PSMF details to XEVMPD (Article 57 database in accordance with Regulation (EC) No. 726/2004 57(2).
Ensure that data consistency and submission timelines are maintained across systems.
Compliance Readiness Checklist
To maintain compliance under the Windsor Framework, we advise PV teams to take the following steps:
- Verify product categorization using MHRA resources.
- Align ICSR workflows to avoid submission errors.
- Monitor EMA and MHRA updates for regulatory developments.
- Validate QPPV/UK National Contact Person (NCP) assignments and PSMF compliance.
- Ensure XEVMPD submissions are timely and accurate for Category 2.
Partnering for PV Compliance with ADAMAS Consulting
ADAMAS Consulting partners with MAHs to deliver expert audits, risk assessments, and tailored compliance solutions, ensuring a smooth and compliant transition. Contact us today to assess your readiness and stay ahead of regulatory demands.
Sources:
- Medicines and Healthcare Products Regulatory Agency. (2025, January 8). Guidance on pharmacovigilance procedures. GOV.UK.
- Medicines and Healthcare Products Regulatory Agency. (2024, August 30). Pharmacovigilance following agreement of the Windsor Framework. GOV.UK.
- Medicines and Healthcare Products Regulatory Agency. (2025, February 7). Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and licensing authority [Guidance note].
- Medicines and Healthcare Products Regulatory Agency. (n.d.). Category 1 lists of products. GOV.UK.
- Medicines and Healthcare Products Regulatory Agency. (n.d.). List of authorised products. GOV.UK.
