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

Current version

PDF iconAdopted 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/11/2008


Published: 30/05/2008


Published: 08/02/2007


Published: 17/11/2005


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