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
Rev 24 of the Q & A with the above title was published on 3 November 2026.
The following changes have been made to the documeny:
- Addition of Q&A 23 on the applicability of the approach to set AI for nitrosamines to other N-Nitroso compounds and
- Addition of Q&A 24 on the applicability of the LTL framework established in the ICH M7 guideline to nitrosamine impurities.
- Consequential updates to Q&As 10, 20 and 22.
- Addition of a new root cause to Q&A 4 and the approach for setting limits for nitrosamines originating in excipients in Q&A 10.
Source: EMA