EMA: Q&A on Nitrosamines Updated to Rev. 18
The EMA Q&A on nitrosamine impurities has been updated on 2 October 2023 and is now available as Revision 18. The update concerns Q&A 3 regarding the “call of review” and how to report steps 1 and 2 to the competent authorities. The update highlights the responsibilities of MAH(s) to control, report, and mitigate the detection of Nitrosamine impurities throughout the product life cycle, using the established procedure.
Even though the deadline for the submission of any changes required to Marketing Authorisations (The Call for Review, Step 1, 2, 3) ended on 1 October 2023, any MAHs that have not reported identified Nitrosamine impurities to the relevant Competent Authority, should do so as a matter of priority, including any updates to previous notifications.
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