EMA/CMDh: Nitrosamines Q&A Document updated again
Recommendation
10/11 February 2026
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In October 2025, the Q&A document "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", which was jointly created by the EMA and the CMDh, was updated and published in the new revision 23 on the EMA website.
The additions and changes made mainly relate to question 22, “What is the approach to control the presence of N-nitrosamine exceeding the AI during CAPA implementation?”, which had already been updated in the previous version. The document's change history provides detailed information on the respective adjustments.
The new version of the Q&A document "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" and further information can be found on the EMA website in the section “Nitrosamine impurities.”
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