Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use
Table of contents
| 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. |
-
List item
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 -
List item
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 -
List item
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 -
List item
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 -
List item
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 -
List item
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