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

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/473191/06 - Corr
Published11/12/2006
Effective from01/07/2007
KeywordsGenetically modified organism (GMO), environmental risk assessment (ERA)
DescriptionThis document explains the application of the centralised procedure to marketing authorisation (MA) applications for medicinal products consisiting 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.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/07/2007–present


Published: 01/12/2006


Published: 20/01/2005

Superseded documentAdopted guidelineIn operation: 01/01/1995–01/07/2007


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