CRED SMPC 2024

23/09/2024

Location and wording to encourage ADR reporting

The Organisation for Professionals in Regulatory Affairs

37

SmPC Advisory Group

Established March 2010 to promote and facilitate the application of the SmPC guideline. The SmPC guideline and other information including training material to help reviewing of SmPCs are available on the EMA website.

How to prepare and review a summary of product characteristics

Best practice approach

The Organisation for Professionals in Regulatory Affairs

38

19