MHRA’s “Pharmacovigilance following agreement of the Windsor Framework” guidance (updated 9 February 2026) clarifies PSUR submission routing: Category 1 PSURs should be submitted via the MHRA PSUR portal, while Category 2 PSURs (and NI MAs) should be submitted via the EU PSUR Repository and generally do not require a separate MHRA submission. Separately, MHRA’s “Guidance on pharmacovigilance procedures” (last updated 8 January 2025) describes MHRA’s PV approach and notes updates adding further detail on submission requirements (including for signals, RMPs and PASS), new PSUR submission requirements for products authorised in Northern Ireland, and added sections on MHRA Safety Reviews and Safety Communications.
PSUR submission routing is an operational compliance control: misclassification of a UK/NI product or use of the wrong submission channel (MHRA PSUR portal vs EU PSUR Repository) can create a risk of missed submissions or duplicate submissions under the post-Windsor Framework operating model described by MHRA. In addition, MHRA’s PV procedures guidance indicates evolving expectations around submissions and documentation—particularly for signals, RMPs and PASS—so PV and regulatory teams need to ensure their UK/NI processes, trackers, and handoffs align with MHRA’s current guidance and the NI-specific PSUR expectations referenced on the MHRA PV procedures page.
1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.
Regulatory Intelligence Lead (coordination) with Aggregate Reports Lead and QPPV oversight
Complete an internal routing/SOP check promptly; then monitor MHRA PV guidance pages for updates on a monthly cadence (or when MHRA update alerts are received).
1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.
MHRA has updated UK guidance affecting pharmacovigilance operations following the Windsor Framework, with a practical focus on where to submit Periodic Safety Update Reports (PSURs) depending on a product’s categorisation and Northern Ireland applicability.
From an operational perspective, the key change for aggregate reporting teams is clarified routing for PSUR submissions. In MHRA’s “Pharmacovigilance following agreement of the Windsor Framework” guidance (updated 9 February 2026), MHRA states that PSURs for Category 1 products should be submitted via the MHRA PSUR portal. In contrast, PSURs for Category 2 products (and Northern Ireland marketing authorisations (NI MAs)) should be submitted via the EU PSUR Repository; MHRA also indicates that, in general, marketing authorisation holders (MAHs) do not need to make a separate PSUR submission to MHRA for a Category 2 product (or NI MA).
For PV teams managing UK/NI compliance controls, this clarification makes product categorisation a critical upstream step. Internal PSUR calendars, submission trackers, and work-instructions need to reflect whether each product falls into Category 1 or Category 2/NI MA status as referenced in MHRA’s Windsor Framework PV guidance. The immediate risk to manage is routing PSURs to the wrong destination (or duplicating submissions when they are generally not required), which could create avoidable compliance issues under the operating model described by MHRA.
In parallel, MHRA’s broader “Guidance on pharmacovigilance procedures” (published 31 December 2020; last updated 8 January 2025) summarises MHRA’s approach to pharmacovigilance and signals that additional submission detail has been added. The MHRA PV procedures guidance page states it was updated to include further details on submission requirements, particularly relating to signals, Risk Management Plans (RMPs) and Post Authorisation Safety Studies (PASS). It also notes that the PSUR section was updated with new requirements for submission of PSURs for products authorised in Northern Ireland, and that additional sections were added on MHRA Safety Reviews and Safety Communications.
Taken together, these updates point to a combined UK/NI compliance review need across aggregate reporting and broader PV governance processes. While the Windsor Framework PV guidance item provides a clear routing rule for PSURs by category, the PV procedures guidance indicates that teams should also re-check MHRA’s stated submission expectations across other PV domains (signals, RMPs and PASS) and ensure internal documentation and quality controls remain aligned.
Practical next steps for PV and regulatory operations should focus on confirming category/NI MA status for each relevant product, implementing the correct PSUR routing logic in trackers and SOPs, and validating that UK/NI processes also reflect the updated submission-detail areas flagged in the MHRA PV procedures guidance. This is particularly relevant for inspection readiness, where evidence of consistent routing decisions, documented procedures, and traceability of submissions are commonly expected.
As noted in MHRA’s Windsor Framework PV guidance excerpt, the statement that a separate MHRA submission is generally not needed for Category 2 products (or NI MAs) may have exceptions; teams should consult the full MHRA guidance for any conditional scenarios before finalising routing rules.
PV, regulatory, and quality teams should complete an internal routing/SOP check promptly and then monitor MHRA PV guidance pages on a monthly cadence (or when MHRA update alerts are received).
Review and update labeling processes in accordance with the newly published safety-related changes for affected products.
MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
Implementation of new dosing schedules and an emphasis on monitoring for potential adverse reactions as outlined in the prescribing information.
Regulatory compliance processes may need updates to incorporate the new recombinant endotoxins testing method and guidelines established under the ICMRA framework.
