This announcement was made immediately prior to the original completion date, October 1, 2020, giving all companies concerned more time to review their manufacturing processes in order to carry out the required risk assessment (Step 1 conduct of risk evaluation). A detailed description of all requirements and access to the Step 1, 2 and 3 templates can be found here.
Please note that the corresponding Q&A document will be adapted by the EMA. The currently effective version of August 3, 2020 can be found here. We will keep you informed about further updates of the document.
The German BfArM also published a notification regarding this update.
EMA: Nitrosamine website
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