publicEuropean Medicines Agency · European Union · Updated Jun 5, 2026
EMA: Updated Day 215 PI Annex Submission Checklist for Post-Opinion Linguistic Review
Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.
LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Checklist
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