New Deadlines and Chances for Nitrosamines

26.08.2022
Are you aware of the latest news on Nitrosamines in Europe and US? 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 (new deadline)
  • 1 July 2023 for biological medicines.

Please consider that the deadline for completing the step 2 confirmatory testing is still 26 September 2022. Don’t forget to submit complete step 2 outcomes by this deadline. 

Furthermore, please have a look into the updated Q&A document from EMA (Rev. 11), considering risk factors, confirmatory testing, and submission of information to Authorities. Don’t forget to always use the latest published templates for your reporting. 

It is important to note that you still have the chance to downgrade your previously submitted Step 1 assessment from "risk" to "no risk" in specific cases, i.e., if data were once missing. So please use the corresponding newly included tick-box in the updated Step 2 template (no nitrosamine detected response template).

In the US, please submit your changes (step 3) by 1 October 2023.

Consider that not only the API, but also excipients and packaging material may lead to nitrosamine impurities in the drug product. Therefore, please consider risk factors already during your development of your drug substance and your drug product. Think about potential new risks if you introduce changes.



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



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