🇪🇺 EMA - Enhanced AMES test conditions

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 productsEnhanced

Ames Test Conditions for N-nitrosamines

IDRAC_374265_15-Nov-2023_EMA_451666_2023_ Enhanced Ames Test Conditions for N-nitrosamines, 12-Oct-2.pdf (159.6 KB)