Scientific requirements for the environmental risk assessment of gene-therapy medicinal products

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Current version

Adopted guideline

Reference numberCHMP/GTWP/125491/06
Published30/05/2008
Effective from01/11/2008
KeywordsEnvironmental risk, genetically modified organism (GMO), gene therapy, medicinal product, deliberate release
DescriptionThis dcument provides guidance on the environmental risk assessment of GMO-containing gene therapy medicinal products, as required for marketing authorisation under the centralised procedure. It aims to facilitate the application of the methodology laid down in the Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.


Document history

First version 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/11/2008


Published: 30/05/2008


Published: 08/02/2007


Published: 17/11/2005


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