Environmental risk assessment of medicinal products for human use - Scientific guideline
Table of contents
This document describes the assessment of potential environmental risks of human medicinal products. Read together with Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use.
Keywords: Environmental risk assessment (ERA), persistence, bioaccumulation, toxicity, PBT, predicted environmental concentration (PEC), Phase I, Phase II
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Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1 (PDF/697.81 KB)
Draft: consultation closed
First published: 30/11/2018
Consultation dates: 01/12/2018 to 30/06/2019
EMEA/CHMP/SWP/4447/00 Rev. 1 -
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Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' - First version (PDF/100.59 KB)
Draft: consultation closed
First published: 04/05/2016
Last updated: 04/05/2016
Consultation dates: 04/05/2016 to 31/10/2016
EMA/CHMP/SWP/65429/2016 -
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Guideline on the environmental risk assessment of medicinal products for human use - First version (PDF/155.23 KB)
Adopted
First published: 01/06/2006
Last updated: 13/01/2015
Legal effective date: 30/11/2006
EMEA/CHMP/SWP/4447/00 Corr 2