eudravigilance
- Guideline or reference source
- EUTCTG European Union Telematics Controlled Terms Glossary of terms
- Definition
- EudraVigilance will now support the Pharmacovigilance activities in the pre- and post- authorisation phase. Therefore, EudraVigilance contains two reporting modules: The EudraVigilance Post-Authorisation module (EVPM) designed for post-authorisation ICSRs 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". The EudraVigilance Clinical Trial (EVCTM) module designed for pre-authorisation SUSARs as required by Directive 2001/20/EC.
- Related Term
- adverse drug reaction
- eudravigilance medicinal product dictionary
- eudravigilance web-based reporting application
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