Update of Q&A document on Nitrosamines New

In November 2026, the CHMP, in alignment with CMDh, agreed on an updated version of the question-and-answers document for marketing authorisation holders and applicants on implementing the Article 5(3) CHMP opinion on Nitrosamines impurities. 

The latest version of this document reflects several changes in the policies and recommendations published to date, such as:

• Higher acceptable intake (AI) limits for nitrosamines impurities, as a result of the full application of the less than lifetime (LTL) approach in ICH M7 for eligible medicines intended for treatments of duration of less than 10 years (see Q&A 24)
• Extension of the Corrective and Preventive Actions (CAPAs) implementation period from 3 to 7 years, under certain conditions (see Q&A 22)
• Inclusion of a new risk factor for nitrosamine formation linked to parenteral products packaged in polymer bags (see Q&A 4)
• Applicability of the approach to establish AI limits for nitrosamines to other N-Nitroso compounds (see Q&A 23)
• Update on limits for nitrosamines originating from excipients (see Q&A 10)

Link: Q&A on Nitrosamines

Further inquiry note

lcm@basg.gv.at