Scientific requirements for the environmental risk assessment of gene-therapy medicinal products - Scientific guideline
Table of contents
This document 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.
Keywords: Environmental risk, genetically modified organism (GMO), gene therapy, medicinal product, deliberate release
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Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products (PDF/116.53 KB)
Adopted
First published: 01/11/2008
Last updated: 01/11/2008
Legal effective date: 30/05/2008
EMEA/CHMP/GTWP/125491/2006 -
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Overview of comments received on draft guideline on the scientific requirements for the environmental risk assessment of gene therapy medicinal products (PDF/81.77 KB)
First published: 30/05/2008
Last updated: 30/05/2008
EMEA/CHMP/GTWP/564874/2007 -
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Draft guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products (PDF/92.32 KB)
Draft: consultation closed
First published: 08/02/2007
Last updated: 08/02/2007
Consultation dates: 01/02/2007 to 01/08/2007
EMEA/CHMP/GTWP/125491/2006