EMA/CMDh: Nitrosamine Q&A Document updated

Recommendation

20 October 2026
Copenhagen, Denmark

Lifecycle Management of Impurities - From Development to Market
An ECA Course prior to the 29th APIC/CEFIC Global GMP & Regulatory API Conference

Once again, the Q&A document "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", which was jointly prepared by the EMA and the CMDh, has been updated and published in the new revision 22 on the EMA website.

The additions and amendments made relate primarily to the following questions:

Question 10 "Which limits apply for nitrosamines in medicinal products?"
Question 22 "What is the approach to control presence of N-nitrosamines exceeding the AI during CAPA implementation?".

The revision history of the document summarises the respective amendments to the chapters.

The new version of the Q&A document "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" and further information can be found on the EMA website in the section "Nitrosamine impurities".