ERA: environmental risk assessment
An environmental risk assessment (ERA) evaluates the potential risk a medicinal product poses to the environment through its use and disposal.
Article 8(3)(ca) of Directive 2001/83/EC requires an ERA in marketing authorisation applications, following EMA's guideline on the environmental risk assessment of medicinal products for human use, revised in 2024. For human medicines the result cannot currently justify refusing authorisation, but it can lead to precautionary measures and labelling.
An ERA is also needed for extensions and variations that increase environmental exposure, such as a new indication. Generic applicants often rely on a justification that exposure will not increase, which is challenged when it is thin.
Under the new pharma package (not yet in force), an inadequate ERA becomes a ground for refusal, and EMA will call in ERAs for pre-October 2005 products it flags; see ERA changes.
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Teams turn ERA requirements into product-level action plans in the obligation-to-action workflow.
Related terms
- Line extension: extension application to an existing authorisationA line extension (in EU terms, an extension application) adds a new strength, pharmaceutical form or route of administration to an authorised product.
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- MAA: marketing authorisation applicationA marketing authorisation application (MAA) is the dossier submitted to EMA or a national authority for permission to market a medicine in the EU.
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