Nitrosamine Risk Assessment (Step 1): new deadlines for BIO and Chemical products announced

by PQE Group

As indicated in the latest updates on HMA.eu official website, the deadlines for Nitrosamine Risk Evaluation (STEP 1), formerly set on October 1st 2020 due to COVID-19 outbreak, have been newly updated as following:

  • March 31st for Chemical medicines.
  • July 1st for Biological medicines.

Anyways, as stated in their Information on nitrosamines for marketing authorization holders | Call for review of chemically synthesised and biological medicinal products, “The European medicines regulatory network encourages marketing authorisation holders to submit the outcome of step 1 before the deadlines if they complete the risk evaluation or identify a risk in their products”.

Other informations on Nitrosamine Risk global alert and implications for Marketing Authorization holders can be found in our article here.

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