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
English (EN) (1.11 MB - PDF)
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)
English (EN) (2.91 MB - PDF)
Document history
Guideline on the environmental risk assessment of medicinal products for human use - Revision 1
English (EN) (1.11 MB - PDF)
Overview of comments received on 'Guideline on the environmental risk assessment of medicinal products for human use’ - Revision 1
English (EN) (358.08 KB - PDF)
Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1
English (EN) (697.81 KB - PDF)
Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' - First version
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.
English (EN) (100.59 KB - PDF)
Guideline on the environmental risk assessment of medicinal products for human use - First version
English (EN) (155.23 KB - PDF)