What changed
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.
Why it matters
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.
Practical implication
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.