Nitrosamines: Step 3 Deadline Extension

The deadline for Step 3 (updating the marketing authorisation) for chemical medicines has been extended from 26 September 2022 to 1 October 2023.

Step 2’s deadline (confirmatory testing) for chemical medicines remains as the 26th of September 2022 and MAHs should still submit their variations as soon as they conclude their investigations.

The extension of Step 3 deadline is to enable companies to perform a thorough investigation and to establish any required risk mitigating actions in light of new scientific developments since 2020.