The long-awaited updated “Guideline on the environmental risk assessment of medicinal products for human use” was released.

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One of the main alterations is that for each ERA, both a risk assessment and a hazard (PBT/vPvB) assessment are now required. The risk assessment reflects the possibility of an effect occurring and is an evaluation of both exposure of organisms in the environment to the active substance, and ecotoxicity. The hazard assessment concerns the identification of intrinsic properties of an active substance that could render it harmful to the environment regardless of the levels of exposure.

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An ERA is required for all new MAAs for a medicinal product submitted through a centralised, mutual recognition, decentralised or national procedure. Applicants are required to submit an ERA irrespective of the legal basis.

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The update ERA guideline comes into effect on 01/09/2024: Guideline on the environmental risk assessment of medicinal products for human use