? Horn Pharmaceutical Consulting - New Deadline for Nitrosamine Impurities

New Deadline for Nitrosamine Impurities

26.03.2020
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 info@horn-pharma.de.

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.


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    Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
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    Live Online Training: Change Control – New Aspects and Best Practices
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News

  • 18.05.2020
    Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
    More
  • 26.03.2020
    New Deadline for Nitrosamine Impurities
    More
  • 24.03.2020
    News on Nitrosamine Impurities
    More
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