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.
EVS Translation Blog / Category: Life sciences translations
As new markets look to become part of the EU, more and more countries are aligning their regulations to provide a swift integration within the next few years.
With the first deadline (1 December 2010) for registering chemical substances under Europe’s REACH legislation, manufacturers and importers are under increasing pressure to comply with the new requirements for Safety Data Sheets preparation.
The global operations of the pharmaceutical industry have been accompanied by a tremendous increase in the demand for high-quality pharmaceutical translations.