 In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet".Each country or region has their own regulatory body.In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet".