EMA/CMDh: Q&A Document Nitrosamines revised

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Recommendation

14/15 October 2025

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In July 2024, the nitrosamine Q&A document "Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorization 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" of the EMA/CMDh was revised again and published on the EMA website under "Questions and answers".

This list of questions and answers was first published in 2020. The new version 21 now contains updates and changes in the following questions and their answers:

8. How should confirmatory tests be conducted by MAHs and manufacturers?
9. What are the requirements of the analytical method(s)?
10. Which limits apply for nitrosamines in medicinal products?
14. What is the approach for new and ongoing marketing authorisation applications (MAA)?
15. When should a test for nitrosamines be included in the MA dossier?
16. What are the responsibilities of MAHs for APIs with CEPs or ASMFs?

The current version of the Q&A document "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" can be found on the EMA website.