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23 Ames BN, Mc Cann J, Yamasaki E (1975) Mutation Res 316:347 European Medicines Agency (2024) European Medicines Agency Appendix 3 to Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5 (3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products