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Australia: TGA updates nitrosamine impurity acceptable intakes in response to European actions

2024/02/05  TGA

The TGA has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information- external site. The changes include minor editorial amendments, increases to the AI limit for a nitrosamine impurity and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.

Sponsors and manufacturers are expected to be familiar with the current acceptable intakes (AI) for nitrosamine impurities in medicines that we consider acceptable. This is detailed on the TGA website.

Visit the TGA website for the updated list of established acceptable intake for nitrosamines in medicines. Updated information on this issue will be published as it becomes available.

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