European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines
The European Medicines
Agency has published a set of updated versions of Extended
EudraVigilance product report message (XEVMPD) controlled vocabularies.
These vocabularies support marketing authorisation holder compliance
with Article 57(2) of the 2010 pharmacovigilance legislation which
requires marketing authorisation holders to submit information to the
Agency electronically on all medicines for human use authorised in the
European Union by 2 July 2012.
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