Let us prepare the environmental risk assessment

The guideline for the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006 (EMEA/CHMP/SWP/4447/00). Please note that the new guideline must be used from 1 September 2024 (see below).

An Environmental Risk Assessment (ERA) shall accompany an application for a marketing authorisation for a medicinal product for human use and is required for all new marketing authorisation applications.

We at REACh ChemConsult GmbH give support in the evaluation of the potential risks of the medicinal product to the environment and offer to create the Environmental Risk Assessment Report according to guideline EMEA/CHMP/SWP/4447/00.

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be considered. In any event this impact should not constitute a criterion for refusal of a marketing authorisation.

On 26 April 2023, a proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use and repealing Directive 2001/83/EC and Directive 2009/35/EC was published by the European Commission. This places particular emphasis on the environmental impact of medicinal products. Recital (70) of the proposal is quoted here, which emphasises the importance of environmental risk assessment/impact assessment: "Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available."

Overview of the applicable guidelines:

• EMA Guideline to be applied from 01. September 2024: Environmental risk assessment of medicinal products for human use - Scientific guideline, and here as pdf for download: Guideline on the environmental risk assessment of medicinal products for human use - Revision 1, Reference Number: EMEA/CHMP/SWP/4447/00 Rev. 1
• EMA Guideline from 2006: Guideline on the environmental risk assessment of medicinal products for human use, Doc. Ref. EMEA/CHMP/SWP/4447/00 corr 2

Contact us without obligation if you have any questions about environmental risk assessment. We would be happy to provide you with a quotation for the preparation of an environmental risk assessment for your medicinal products for human use.