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Environmental risk assessment for a generic medicine is still a regulatory assessment of environmental exposure and potential risk. The required evidence and scope depend on the product, active substance, intended use, market and applicable submission framework.
The regulatory framework applies to human medicinal products, and current UK guidance states that an ERA is required for marketing authorisation applications irrespective of the legal basis. EU requirements should be assessed against the current EMA guideline and the specific submission context.
Confirm the active substance, maximum daily dose, intended indications, prevalence assumptions, route of administration, environmental evidence, existing regulatory information and the intended EU/UK submission pathway.
Public ERA summaries, older assessments or data from another product may help scope the project, but their applicability and access rights should be reviewed rather than assuming they can simply be transferred to a new product or submission.
Share the substance, product context, intended market and regulatory requirement. ToxWriter can review the scope and confirm the appropriate assessment pathway.