Summary of product characteristics (SmPC)

In 2005, the European Commission adopted the Guideline on Summary of Product Characteristics, October 2005 with general guidelines for the way in which information needs to be stated in the SmPC.

The MEB has drafted a Commentary on the ‘Guideline on Summary of Product Characteristics’ (MEB 27). Information already published in the Guideline and/or the QRD template, is not repeated in the explanatory document.

The SmPC states per category if there are specific MEB requirements or preferences.

The Guideline transcends existing Notes for Guidance for the SmPC of certain substances or pharmaceutical groups.