Primary source: European Medicines Agency (EMA)
EMA revised the checklist for submission of Day 215 product information annexes (SmPC, labeling, package leaflet) for post-opinion linguistic review under the centralized procedure.
Ensures consistency and quality in final safety information before authorization, reducing risk of linguistic errors in safety warnings.
Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.
Regulatory Intelligence Lead
quarterly
Updates the requirements and formatting checks for the final product information annexes, including SmPC, labeling, and package leaflet, to be submitted for linguistic review.
Ensures consistency and quality in the final safety information provided in the SmPC and package leaflets before final authorization, reducing the risk of linguistic errors in safety warnings.
Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.
EMA has updated its Day 215 submission checklist for post-opinion linguistic review. Marketing authorization holders must use this revised checklist to prepare and submit product information annexes (SmPC, labeling, package leaflet) to ensure formatting consistency and reduce linguistic errors in safety information.
What changed: EMA revised the checklist for submission of Day 215 product information annexes (SmPC, labeling, package leaflet) for post-opinion linguistic review under the centralized procedure.
Why it matters: Ensures consistency and quality in final safety information before authorization, reducing risk of linguistic errors in safety warnings.
Practical implication: Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.
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