Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs) - Scientific guideline HumanScientific guidelines
Page contentsPage contents Current effective version Document history - First version Superseded document Related content Topics This document explains the application of the centralised procedure to marketing authorisation (MA) applications for medicinal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) Current effective version Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)Adopted Reference Number: EMEA/CHMP/BWP/473191/2006 - Corr Legal effective date: 01/07/2007 English (EN) (109.23 KB - PDF)First published: 11/12/2006 Last updated: 11/12/2006 View Document history - First version Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2)Draft: consultation closed Reference Number: EMEA/CHMP/BWP/135148/2004 English (EN) (134.1 KB - PDF)First published: 20/01/2005 Last updated: 20/01/2005 View Overview of comments received on draft guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)Reference Number: EMEA/CHMP/BWP/480303/2006 - Corr English (EN) (39.08 KB - PDF)First published: 01/12/2006 Last updated: 01/12/2006 View Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)Adopted Reference Number: EMEA/CHMP/BWP/473191/2006 - Corr Legal effective date: 01/07/2007 English (EN) (109.23 KB - PDF)First published: 11/12/2006 Last updated: 11/12/2006 View Superseded document Environmental risk assessment for Human Medicinal products containing or consisting of GMOSAdopted Reference Number: 3BR1a Legal effective date: 01/01/1995 English (EN) (52.04 KB - PDF)First published: 04/12/1998 Last updated: 04/12/1998 View Related content Biologicals: finished product Non-clinical: environmental risk assessment Environmental risk assessment of medicinal products for human use Quality of biological active substances produced by transgene expression in animals Scientific requirements for the environmental risk assessment of gene-therapy medicinal products Topics Scientific guidelines Share this page Back to top