EudraVigilance database- Pharmacovigilance

The EudraVigilance database contains two reporting modules

1.The EudraVigilance Post-Authorisation module (EVPM) designed for postauthorisation Individual Case Safety Reports (ICSR) as required by Council Regulation No. 2309/93/EEC, as amended (to be replaced by Regulation (EC) No 726/2004 in November 2005), Directive 2001/83/EC, as amended, and Volume 9 of the "Rules Governing Medicinal Products in the European Union".
2.The EudraVigilance Clinical Trial (EVCTM) module designed for pre-authorisation serious unexpected suspected adverse reactions (SUSAR) (pre-authorisation Individual Case Safety Reports - ICSR) as required by Directive 2001/20/EC. As a general rule all SUSAR reports originating from any interventional clinical trial (Phase I – IV) as defined in Directive 2001/20/EC are sent electronically to the EVCTM. This includes, when applicable the comparator (active control or placebo). The database provides and facilitates an overview of SUSAR and provides for enhanced protection of clinical trial subjects.



It is closely linked for the identification of the product and clinical trial, and other clinical trial information, to the clinical trial EudraCT database. An interface is planned.