Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs) - Scientific guideline
This document explains the application of the centralised procedure to marketing authorisation (MA) applications for medicinal products consisting of or containing genetically modified organisms. It outlines both the procedural issues affecting applications for MA for these products and the information related to the environmental risk assessment which should be included in the applications.
Keywords: Genetically modified organism (GMO), environmental risk assessment (ERA)
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Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2) (PDF/134.1 KB)
Draft: consultation closed
First published: 20/01/2005
Last updated: 20/01/2005
EMEA/CHMP/BWP/135148/2004 -
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Overview of comments received on draft guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs) (PDF/39.08 KB)
First published: 01/12/2006
Last updated: 01/12/2006
EMEA/CHMP/BWP/480303/2006 - Corr -
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Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs) (PDF/109.23 KB)
Adopted
First published: 11/12/2006
Last updated: 11/12/2006
Legal effective date: 01/07/2007
EMEA/CHMP/BWP/473191/2006 - Corr