Date of Publication: 27-Mar-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency has published updated procedural advice for users of the centralised procedure, providing important guidance for marketing authorisation holders (MAHs) managing post-authorisation activities.
The document outlines key requirements for variations, renewals, transfers, pharmacovigilance submissions, PSURs, and product information updates, helping companies navigate regulatory expectations more efficiently.
It also highlights the importance of submission accuracy, correct eCTD formatting, and timely updates to SmPC, labelling, and package leaflet documentation in line with EMA requirements.
Overall, this document serves as a useful reference for regulatory teams to support smoother submissions, stronger compliance, and effective lifecycle management of centrally authorised products.
KEYWORDS: Centralised Procedure, Renewal Submission, Pharmacovigilance
REFERENCE: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf