Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use

The European Medicines Agency’s (EMA) Environmental Risk Assessment (ERA) guidelines are set to come into effect on September 1, 2024.

This EMA Environmental Risk Assessment guideline is crucial for everyone involved in the pharmaceutical industry, as it outlines the mandatory requirements for including an ERA in marketing authorisation applications (MAAs) for medicinal products. Understanding and adhering to these guidelines is essential to ensure compliance and to mitigate potential environmental impacts.

Mandatory ERA for Marketing Authorisation Applications

The inclusion of an ERA in an MAA is not optional. It applies to various types of applications, ensuring that all medicinal products undergo thorough environmental scrutiny. This requirement spans across different application types, including:

  • Art 10(1): Generic medicinal products
  • Art 10(3): Hybrid applications
  • Art 10(4): Similar biological applications
  • Art 10a: Well-established use/bibliographical applications
  • Art 10b: Fixed combinations
  • Art 10c: Informed consent applications

The ERA ensures that even products developed under these different routes are evaluated for their environmental impact, reflecting a comprehensive approach to environmental safety in the pharmaceutical sector.

Components of the ERA

The ERA is a multifaceted assessment based on several critical factors:

  • Product Usage: This considers how the medicinal product will be used in real-world settings.
  • Physico-chemical Properties: These are the inherent characteristics of the active substances, such as solubility and stability.
  • Ecotoxicological Properties: This involves understanding the potential ecological impacts of the substance, including toxicity to aquatic and terrestrial organisms.
  • Fate Properties: This examines how the substance behaves in the environment, including its persistence, bioaccumulation, and potential for degradation.

These components collectively help in assessing the potential risks a medicinal product might pose to the environment. The guideline provides detailed instructions on how to perform the ERA and assess these risks effectively.

Submission of the ERA

The ERA must be included in Module 1.6 of the MAA. This ensures that the environmental impact assessment is integrated into the regulatory submission process, providing a clear and structured approach for regulatory reviewers. Detailed guidance on completing this assessment can be found in the EMA’s guideline document, which is essential reading for all regulatory professionals involved in preparing MAAs.

For more information, you can access the full guideline here: Guideline on the environmental risk assessment of medicinal products for human use.

Need Help?

Navigating the complexities of ERA submissions can be challenging. If you have questions about dossiers, and their content, or need any support, please get in touch with us at Our experienced team is here to assist you with all your regulatory needs, ensuring your submissions are thorough, accurate, and compliant with the latest guidelines.

Stay informed and ensure compliance with these new guidelines to protect both public health and the environment. By integrating these practices into your regulatory processes, you contribute to a safer, more sustainable future.

James Hall