EMA to translate product information changes into all EU languages

The European Medicines Agency (EMA) will translate its recommendations into all the official languages of the European Union, as well as into Norwegian and Icelandic; these will be then transmitted to companies to update the product information of their drugs.  This measure will accelerate the implementation of variations and ensure their consistency across EU Member States. The measure is also expected to reduce the administrative burden and translation costs for pharmaceutical companies, as well as supporting national regulatory agencies in their work. Translations will be available approx. 3 weeks after the publication of the product information in English. National Competent Authorities will be requested to review the translations’ quality. Safety recommendations are issued by the European Agency following the assessment of safety signals reported during the Pharmacovigilance activities.