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)