In the European Union (EU), a medicine’s product information (PI), which includes the summary of  product characteristics (SmPC, intended for healthcare professionals), labelling (outer and inner  packaging information) and package leaflet (PL, for patients/consumers and generally included as a printed copy in the medicines package, is the pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs patients and consumers about its safe use

Download here :

Electronic product information for human medicines in the EU – draft key principles