2021-06-27 19:57 The SmPC is part of the broader Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. Accurate translation of drug instruction texts, especially those on vials, bottles, blister, and sachet, as well as Patient Information Leaflet (PIL), is important to pharmaceutical companies and patients. Translation errors must be critically avoided.