CRED SMPC 2024

23/09/2024

The SmPC: Regulator’s Perspective

CRED SmPC, Patient Information Leaflet and Labelling

Dr Ronan Donelan

HPRA

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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➢ The role of the SmPC ➢ Overview of SmPC legislation/guidelines and template ➢ Regulators perspective ➢ Current issues and developments

Special thanks to Dr Doreen Fagan, HPRA

The Organisation for Professionals in Regulatory Affairs

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