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The UK Medicines and Healthcare products Regulatory Agency (MHRA) states that marketing authorisations require an evaluation of potential environmental risks and expects ERA submissions to be consistent with the EMA human-medicines ERA guideline, with UK-specific considerations where applicable.
For human medicinal products, the MHRA guidance states that an ERA or justification for its absence is required as part of a marketing authorisation application. It also describes ERA requirements for relevant post-approval changes where environmental exposure is anticipated to increase.
The MHRA guidance states that, for UK submissions, an evaluation of predicted environmental concentration based on UK prevalence should be provided where available. An EU member-state prevalence approach may be acceptable where it is sufficiently conservative compared with UK prevalence.
The UK guidance states that applicants and marketing authorisation holders are expected to provide an ERA consistent with the EMA Guideline on the environmental risk assessment of medicinal products for human use (Revision 1).
The MHRA guidance states that the ERA, or justification for its absence, should be included in Module 1.6 of the eCTD for initial marketing authorisation applications.
Share the substance, product context, intended market and regulatory requirement. ToxWriter can review the scope and confirm the appropriate assessment pathway.