Environmental risk assessment of medicinal products for human use - Scientific guideline

This guideline describes the assessment of potential environmental risks of human medicinal products. 

Keywords: Environmental risk assessment (ERA), persistence, bioaccumulation, toxicity, PBT, predicted environmental concentration (PEC), Phase I, Phase II

Current version - effective from 1/09/2024

Guideline on the environmental risk assessment of medicinal products for human use - Revision 1

Adopted Reference Number: EMEA/CHMP/SWP/4447/00 Rev. 1 - Corr. Legal effective date: 01/09/2024

Overview of comments received on the ’Guideline on the environmental risk assessment of medicinal products for human use’ (EMEA/CHMP/SWP/4447/00 Rev. 1)

Reference Number: EMA/CHMP/422204/2024

Document history

Guideline on the environmental risk assessment of medicinal products for human use - Revision 1

Adopted Reference Number: EMEA/CHMP/SWP/4447/00 Rev. 1 - Corr. Legal effective date: 01/09/2024

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 guideline on the environmental risk assessment of medicinal products for human use - Revision 1

Draft: consultation closed Consultation dates: 01/12/2018 to 30/06/2019 Reference Number: EMEA/CHMP/SWP/4447/00 Rev. 1

Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' - First version

Draft: consultation closed Consultation dates: 04/05/2016 to 31/10/2016 Reference Number: EMA/CHMP/SWP/65429/2016 Summary:

In 2006, the 'Guideline on Environmental Risk Assessment of Medicinal Products for Human Use' (EMEA/CHMP/SWP/4447/00) was published. The purpose of the guideline is to describe the assessment of potential environmental risks of human medicinal products including considerations for risk mitigation measures to limit their impact on the environment. Minor, editorial, changes have been included at later stages in the current version (EMEA/CHMP/SWP/4447/00 Corr. 2). A Questions and Answer document (EMA/CHMP/SWP/44609/2010) to the Guideline was released in 2011, and has been updated recently.

Guideline on the environmental risk assessment of medicinal products for human use - First version

Adopted Reference Number: EMEA/CHMP/SWP/4447/00 Corr 2 Legal effective date: 30/11/2006