Written by ForeignExchange Translations on Monday, December 19, 2011
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:
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