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

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

Current effective version

Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products

AdoptedLegal effective date: 30/05/2008Reference Number: EMEA/CHMP/GTWP/125491/2006

Document history - First version (current)

Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products

AdoptedLegal effective date: 30/05/2008Reference Number: EMEA/CHMP/GTWP/125491/2006

Overview of comments received on draft guideline on the scientific requirements for the environmental risk assessment of gene therapy medicinal products

Reference Number: EMEA/CHMP/GTWP/564874/2007

Draft guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products

Consultation dates: 01/02/2007 to 01/08/2007Draft: consultation closedReference Number: EMEA/CHMP/GTWP/125491/2006