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

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.

Keywords: Environmental risk assessment (ERA)

Current effective version

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

AdoptedReference Number: EMA/CHMP/SWP/44609/2010 Rev. 1

Document history

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

AdoptedReference Number: EMA/CHMP/SWP/44609/2010 Rev. 1

Overview of comments received on 'Guideline on the environmental risk assessment of medicinal products for human use’ - Revision 1

Reference Number: EMA/CHMP/SWP/96156/2016

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

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

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/44609/2010Summary:

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

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