publicEuropean Medicines Agency · European Union · Updated Aug 19, 2026
European Medicines Agency Pre-Authorisation Procedural Advice Updates
Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.
Country ComplianceLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV
verifiedRegulatory action: Procedural Guideline
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