Summary of Product Characteristics (SPC/SmPC): Introduction, Overview, and relevance in aggregate reports
Summary of Product Characteristics (SPC/SmPC): Introduction, Overview, and Relevance in aggregate reports
In this article, I mean to introduce a summary of product characteristics (SmPC or SPC), what it is, contents (the sections it has), a high-level overview of various key SPC sections (with focus on sections 4.4 and 4.8), and its contents, what makes SmPC so special,