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Detailed GuideMHRA

Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing

Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.

First published: Dec 18, 2019Last updated: Feb 25, 2026Changes: 21

Latest change: Updated page to add new information on responsibilities and reporting on nitrosamine impurities

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