Language translation and localisation challenges for the pharmaceutical industry in the EU
25 Aug /10

Language translation and localisation challenges for the pharmaceutical industry in the EU

For medicines EMEA and the various national medicine evaluation agencies require that the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labelling texts be presented at least in the official language or languages of the Member States in which the medicinal product is placed on the market.