PV Bulletin

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Regulatory Compliance

publicEuropean Medicines Agency · European Union · Updated Sep 9, 2026

XEVPRM User Guidance Version 3.21 Update

Urgency: High

Review the updated guidance to incorporate the new compliance procedures starting from 1 January 2026, specifically regarding the electronic submission process.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Regulators
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