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Country GuidesMhraUnited Kingdom

MHRA clarifies PSUR submission routes for Category 1 vs Category 2

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadPV Operations Lead+3 more
Action needed

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.

Process impact
Signal ValidationLocal Affiliate ComplianceInspection Readiness
SOP impact

8 SOPs may need review

Urgency: HighConfidence: high
Read impact brief →
Country GuidesMhra

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadPV Operations Lead+4 more
Action needed

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Process impact
Signal ValidationRisk ManagementLocal Affiliate Compliance
SOP impact

9 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →

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