Pharmacovigilance Europe

Edwards IR. Who cares about pharmacovigilance Europ J Clin Pharmacol 1997 53 83-8. 

The requirements for pharmacovigilance systems in Europe are contained in Directive 2001/82/EC and Directive 2001/83/EC, and Regulation (EC) No. 726/ 2004, and supported by guidance extensive guidance set out in The Rules Governing Medicinal Products in the European Union, Volume 9, Pharmacovigilance. 

Pharmacovigilance in the post-marketing authorization period is tightly regulated. As in North America and Japan, Europe has adopted the ICH guidelines with a few, relatively minor additions. The MA holder must have systems and qualified personnel in place to fulfill all his obligations for the monitoring of the safety of its medicinal products. 

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