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.
When more than one language is used, all the texts must be in each individual language and the contents of all language versions must be identical.
A manufacturer cannot apply for a drug registration without submitting the relevant translated and properly localised versions of these documents to the European or national regulatory authorities.
Regulatory Affairs Departments of pharmaceutical companies need to work together with professional language translation providers, preferably on a long-term basis.




























