EU Update regarding Deadlines of Nitrosamine Impurities

Are you aware of the latest news on Nitrosamines in Europe? Do you know the details and deadlines? HORN Pharmaceutical Consulting is glad to help you find out more.
After completion of confirmatory testing, you as the Marketing Authorisation Holder should submit your variation applications in EU by:
  • 01 October 2023 for chemical medicines 
    • deadline extension: previously: 26. Sept. 22
  • 1 July 2023 for biological medicines.

EDQM also extended the deadline for CEP-holders to submit their step 3 revisions by 1 October 2023.
Don’t forget to have a look into the updated Q&A document from EMA (Rev. 13, Dec 22), considering risk factors, confirmatory testing, and submission of information to Authorities. In the latest update of the Q&A document you will find the new limits that apply for nitrosamines in drug products (Question 10).

Please feel free to contact us at, if you need support on these activities.
We know the details and guide you through the process.



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