European Medicines Agency (EMA) | What's new Follow Nitrosamines EMEA-H-A5(3)-1490 - 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 https://www.ema.europa.eu/system/files/documents/opinion-on-any-scientific-matter/nitrosamines-emea-h-a53-1490-qa-art-53-rev-23-en.pdf ema.europa.eu
