www.fdanews.com/articles/138354-ema-publishes-format-for-electronic-submissions-for-pharmacovigilance-law
EMA Publishes Format for Electronic Submissions for Pharmacovigilance Law
July 13, 2011
Marking its first step to implement recent pharmacovigilance legislation, the European Medicines Agency (EMA) has published formatting requirements for manufacturers to use when they submit authorized or registered medicines in the EU.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor