Environmental Risk Assessments for Medicines
Summary
The MHRA published guidance on environmental risk assessments (ERAs) for medicinal products in the UK, effective 1 April 2026. All marketing authorisation (MA) applications must now include an evaluation of potential environmental risks posed by the medicinal product, assessing the physicochemical and ecotoxicological properties and environmental fate of the active substance. Where environmental risk cannot be excluded, applicants must propose specific measures to limit environmental impact, with precautionary measures included in the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) as applicable.
“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).”
All marketing authorisation applicants for medicinal products in the UK must now submit an environmental risk assessment as part of their application under Schedule 8 of the Human Medicines Regulations. Applicants with pending applications should review their ERA documentation to confirm it covers physicochemical properties, ecotoxicological effects, and environmental fate of the active substance. Where risks cannot be excluded, appropriate precautionary measures should be incorporated into SmPC and patient information leaflets.
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA published guidance on environmental risk assessments (ERAs) for medicinal products effective 1 April 2026, setting out expectations under Schedule 8 of the Human Medicines Regulations. All marketing authorisation applications must include an ERA evaluating the physicochemical properties, ecotoxicological profile, and environmental fate of the active substance. Where environmental risk cannot be excluded, applicants must propose specific measures to limit environmental impact, with precautionary measures reflected in the SmPC and PIL where applicable.
Pharmaceutical companies seeking UK marketing authorisation should ensure their ERA documentation addresses all three assessment pillars (physicochemical, ecotoxicological, and environmental fate) and includes proposed mitigation measures where environmental risk cannot be ruled out. Companies with applications in progress should verify compliance with the updated expectations.
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Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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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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.
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Published 1 April 2026
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