Nitrosamine Impurities

Published: 28/8/2020

Marketing Authorisation Holders' submission of nitrosamine risk evaluation

During the second week of August 2020, it was informed by the MHRA that the deadline for provision of the responses has been extended consistent with the decision and announcement of EMA on 6th. of August 2020.

Furthermore, the scope of the review has been widened to cover all medicinal products for human use authorised in the EU/EEA and UK, since biological active substances have been also added to the scope in July 2020, as an outcome of CHMP's Article 5(3) opinion.

In order to allow Marketing Authorisation Holders enough time comply, the European Medicines regulatory network agreed new deadlines, as stated below:

Step 1: Risk evaluation:
Conduct a risk evaluation to identify active substances and finished products at risk of N-nitrosamine formation or (cross-) contamination and report the outcome by:

  • 31 March 2021 for chemical medicines;
  • 1 July 2021 for biological medicines.

Step 2: Confirmatory testing + Step 3: Update of MAs:
Marketing Authorisation Holders should complete the confirmatory testing and submit their variation applications by:

  • 26 September 2022 for chemical medicines;
  • 1 July 2023 for biological medicines.

So as to achieve these deadlines, it is necessary to perform the step 2 confirmatory testing activities in advance.

Further details are available here:
EMA :…s/nitrosamine-impurities
MHRA :…rosamine-risk-evaluation

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