We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include minor editorial amendments and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines. The AI changes are tabulated on the updates to nitrosamines and other nitroso-structures page.
Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities and other nitroso-structure impurities in medicines.
See our updated information for sponsors and manufacturers, list of established acceptable intake for nitrosamines in medicines and list of established acceptable intake for other nitroso-structures impurities in medicines. Further updated information on this issue will be published as it becomes available.