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

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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