Virus safety evaluation of biotechnological investigational medicinal products

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/BWP/398498/2005
Published24/07/2008
Effective from01/02/2009
KeywordsVirus safety, clinical trial, investigational medicinal products (IMPs)
DescriptionThis document provides scientific guidance on the viral safety of biotechnological medicinal products used in clinical trials.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/02/2009–present


Published: 17/09/2008


Published: 28/06/2006


Published: 15/12/2004


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