EMEA: Guideline on Summary of Product Characteristics Rev.

This guideline provides advice on the principles of presenting information in the SmPC. Applicants should maintain the integrity of each section of the document by only including information in each section which is relevant to the section heading. However, some issues may need to be addressed in more than one section of the SmPC and in such situations the individual statements may cross-refer to other sections when these contain relevant additional information.