Medical Translation Insight

The EudraVigilance Medicinal Products Dictionary (EVMPD) was developed by the European Medicines Agency (EMA) to aid pharmacovigilance activities in the European Economic Area and was designed to support the collection, reporting, coding, and evaluation of both investigational and authorized medicinal product information in a standardized manner.

On July 1, 2011, as a step in implementing new pharmacovigilance legislation in the EU, the EMA published the format in which pharmaceutical companies will need to submit information on all of their drugs authorized or registered—by whatever authorization route—in the EU. The new format will go into effect on July 2, 2012.

Obviously, this new format and the related reporting requirements will impact all companies marketing pharmaceuticals in the EU. We've prepared a white paper in order to help companies prepare for the July 2, 2012 deadline. You can download it here:
http://info.fxtrans.com/complying-with-emas-new-mandatory-requirement-for-medicinal-product-information/


ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.