Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use

Keywords	Environmental risk assessment (ERA)
Description	This document aims to provide clarification and to harmonise the use of the guideline on the environmental risk assessment of medicinal products for human use.

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Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1 (PDF/343.58 KB)

Adopted

First published: 02/06/2016
EMA/CHMP/SWP/44609/2010 Rev. 1
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Overview of comments received on 'Guideline on the environmental risk assessment of medicinal products for human use’ - Revision 1 (PDF/358.08 KB)

First published: 02/06/2016
EMA/CHMP/SWP/96156/2016
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Draft questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1 (PDF/217.44 KB)

Draft: consultation closed

First published: 31/03/2015
Consultation dates: 31/03/2015 to 30/06/2015
EMA/CHMP/SWP/44609/2010 Rev. 1
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Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - First version (PDF/190.94 KB)

First published: 11/04/2011
EMA/CHMP/SWP/44609/2010
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Overview of comments received on 'Questions and answers on Guideline on the environmental risk assessment of medicinal products for human use' - First version (PDF/324.11 KB)

First published: 11/04/2011
EMA/CHMP/SWP/739571/2010
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Draft questions and Answers on the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use - First version (PDF/159.83 KB)

Draft: consultation closed

First published: 19/07/2010
Consultation dates: 24/06/2010 to 30/09/2010
EMA/CHMP/SWP/44609/2010