Environmental Risk Assessments for Medicines

MHRA Guidance & Safety

Published April 1st, 2026

Detected April 2nd, 2026

Summary

MHRA published guidance on environmental risk assessments (ERAs) for medicinal products in the UK. The guidance clarifies that all marketing authorisations require evaluation of potential environmental risks under Schedule 8 of the Human Medicines Regulations. Marketing authorisation holders must assess physicochemical and ecotoxicological properties and environmental fate of active substances, proposing mitigation measures where risks cannot be excluded.

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What changed

MHRA issued guidance explaining environmental risk assessment requirements for all medicinal products seeking UK marketing authorisation. The guidance references Schedule 8 of the Human Medicines Regulations, which already mandates ERA evaluation. Key requirements include assessment of the active substance's physicochemical properties, ecotoxicological data, and environmental fate. Where environmental risk cannot be excluded, marketing authorisation holders must propose specific measures to limit environmental impact.

Pharmaceutical companies and marketing authorisation holders should review their existing ERA processes against this guidance. Measures to limit environmental impact should be incorporated into the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) where applicable. This guidance provides clarity on MHRA expectations but does not impose new legal requirements beyond those in the Human Medicines Regulations.

What to do next

Review existing ERA processes to ensure compliance with MHRA guidance
Update SmPC and PIL templates to include environmental impact mitigation measures where applicable

Source document (simplified)

Guidance

Environmental Risk Assessments in medicines

This guidance sets out the expectations for environmental risk assessments (ERAs) for medicinal products in the UK.

From: Medicines and Healthcare products Regulatory Agency Published 1 April 2026 Get emails about this page

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Environmental Risk Assessments in medicines

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Details

All marketing authorisations (MAs) require an evaluation of the potential environmental risks posed by the medicinal product, as specified in Schedule 8 of the Human Medicines Regulations (HMR). This includes an assessment of the product’s potential environmental impact and a description of the proposed arrangements for limiting that impact.

An ERA evaluates the risk to the environment arising from use of the product, taking into account the physicochemical and ecotoxicological properties, as well as the environmental fate, of the active substance. Where the possibility of environmental risk cannot be excluded, specific measures to limit environmental impact should be proposed. Appropriate precautionary and safety measures should be included in the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL), where applicable.