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

This document was used to provide clarification and to harmonise the use of the guideline on the environmental risk assessment of medicinal products for human use. 

It is no longer in force, please refer to environmental risk assessment of medicinal products for human use for the currently effective version.

Keywords: Environmental risk assessment (ERA)

Document history

Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1

Adopted Reference Number: EMA/CHMP/SWP/44609/2010 Rev. 1

Draft questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1

Draft: consultation closed Consultation dates: 31/03/2015 to 30/06/2015 Reference Number: EMA/CHMP/SWP/44609/2010 Rev. 1 Summary:

The aim of the current question-and-answer document is to provide clarification and to harmonise the use of the 'Guideline on the environmental risk assessment of medicinal products for human use' (EMEA/CHMP/SWP/4447/00).

Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - First version

Reference Number: EMA/CHMP/SWP/44609/2010 Summary:

The aim of this question-and-answer document is to provide clarification and to harmonise the use of the 'Guideline on the environmental risk assessment of medicinal products for human use' (EMEA/CHMP/SWP/4447/00).

Overview of comments received on 'Questions and answers on Guideline on the environmental risk assessment of medicinal products for human use' - First version

Reference Number: EMA/CHMP/SWP/739571/2010

Draft questions and Answers on the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use - First version

Draft: consultation closed Consultation dates: 24/06/2010 to 30/09/2010 Reference Number: EMA/CHMP/SWP/44609/2010