Pharmacovigilance Document Library

Here you can find regulatory documents on the topic of pharmacovigilance:

VOLUME 9A of the Rules Governing Medicinal Products in the European Union 9 – Guidelines on Pharmacovigilance for Medicinal Products for Human Use; Version March 2007 (Englisch)

Directive 2001/83/EC of the European parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use; Version April 2004 (Englisch)

Directive 2010/84/EU of the European parliament and of the Council; Version December 2010 (Englisch)

Regulation (EU) No. 1235/2010 of the European parliament and of the Council; Version December 2010 (Englisch)

Important Medical Event (IME) List (EMA Document) MedDRA 13.1 (Englisch)