CRED SMPC 2024

23/09/2024

EC SmPC Guidelines

The Organisation for Professionals in Regulatory Affairs

13

SmPC Guidelines – EC 2009

The SmPC guideline advises on the principles of presenting information in the SmPC

• Clear and concise language

• Consistent terminology

• Product specific information for use in the population for whom the medicine is indicated followed – where necessary – by information for any relevant special population

(Public Assessment Report provides more detailed information)

The Organisation for Professionals in Regulatory Affairs

14

7