PV Bulletin

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Variations

publicEuropean Medicines Agency · European Union · Updated Jul 21, 2026

Mandatory Use of PLM Portal eAF for CAP Variations

Urgency: High

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Procedural Notice / Release Notes
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publicEuropean Medicines Agency · European Union · Updated Jul 3, 2026

Variations Requiring Assessment (Veterinary Medicines) - Q&A Update

Urgency: High

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Q&A
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