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)

Current effective version

Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)

AdoptedLegal effective date: 01/07/2007Reference Number: EMEA/CHMP/BWP/473191/2006 - Corr

Document history - First version

Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2)

Draft: consultation closedReference Number: EMEA/CHMP/BWP/135148/2004

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

Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)

AdoptedLegal effective date: 01/07/2007Reference Number: EMEA/CHMP/BWP/473191/2006 - Corr

Superseded document

Environmental risk assessment for Human Medicinal products containing or consisting of GMOS

AdoptedLegal effective date: 01/01/1995Reference Number: 3BR1a