New Deadline for Nitrosamine Impurities

Risk Evaluation: Extension of Deadline for CEP-Holders until 31.July 20 and for MAH (Marketing Authorisation Holders) until 1.October 2020

The deadline of 26.03.20 to complete step 1 (Risk evaluation) was extended for MAHs and for CEP-Holders due to due to major challenges in meeting the deadlines and due to COVID-19 pandemia.

For further information:

Are you still working on your risk assessment and do you need professional support?

Then, contact us at

We know the details of these new requirements. We help you with your CEPs, DMFs and Marketing Authorizations. You can benefit from our long term-experience.



Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528


  • 13.-14.07.2020
    Live Online Seminar: Der Regulatory Affairs Manager
  • 25.08.2020
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
  • 06.-07.10.2020
    Vienna: Change Control – New Aspects and Best Practices
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  • 18.05.2020
    Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
  • 26.03.2020
    New Deadline for Nitrosamine Impurities
  • 24.03.2020
    News on Nitrosamine Impurities
Get all news
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