Nitrosamines Risk Assessment – Steps 2 and 3

MAHs are reminded that all activities related to Step 2 – Confirmatory Testing and related investigations in case of confirmed presence of nitrosamines should be performed sufficiently in advance to ensure that the necessary variation(s) can be submitted by the Step 3 deadlines, i.e. by  26 September 2022 for chemical medicines or 1 July 2023 for biological medicines.

Steps & Deadlines Chemical medicines Biological medicines
Step 2 – Confirmatory Testing 26 September 2022 01 July 2023
Step 3 – Update marketing authorisations 26 September 2022 01 July 2023

The implementation of the risk controls and mitigation studies may result in changes to the current manufacturing process, controls and specification, product formulation, raw materials and/or packaging, etc.

The necessary variation(s) to the marketing authorisation for the purposes of implementing these risk controls should contain information on amendments to the 3.2.S and/or 3.2.P dossier sections.

These variation(s) should be submitted according to the existing variations classification guideline through the usual channels by the above deadlines.

The variation(s) should be clearly identified in the reason comment that the change is the outcome of the step 2 risk assessment and confirmatory testing.

Worksharing is highly recommended in all cases where the same variation applies to several national or MRP/DCP products.

If you need any clarification or support to help implement the responsibilities of a MAH with regard to Nitrosamines contact us  and Ivowen will gladly assist you in a timely manner.

Written by Fiona Downey

fiona downey