Environmental risk assessment of medicinal products for human use

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Current effective version

Adopted guideline


Currently under revision - see below 

Reference numberCPMP/SWP/4447/00
Published01/06/2006
Effective from01/12/2006
KeywordsEnvironmental risk assessment (ERA), persistence, bioaccumulation, toxicity, PBT, predicted environmental concentration (PEC), Phase I, Phase II
DescriptionThis document describes the assessment of potential environmental risks of human medicinal products. Read together with questions and answers.


Document history

Revision 1

In progress

Concept paper

Published: 04/05/2014

Deadline for comments: 31/10/2016

First version

Current version

Adopted guideline

In operation: 01/12/2006–present


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