Virus safety evaluation of biotechnological investigational medicinal products

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/BWP/398498/2005
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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