PhaRegistrum · Originally published on 04/12/2025
INFARMED’s SMUH-ALTER portal now allows marketing authorisation holders to include additional information for changes to medicine name (A.2.b), shelf life and storage conditions (B.II.f), and European Pharmacopoeia Certificates of Suitability (B.III.1.a).
The portal also allows submission of the national pharmacovigilance contact. All holders must update this information by 31 January 2026.
The update aims to optimise INFARMED database updates, improve information integrity and simplify submission.
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