I would appreciate your experience on this Nitrosamine topic.
The initial deadline for Nitrosamines step 1 risk evaluation was the 26th of March 2020. The initial practical advice from the CMDh was to submit the conclusions of the risk assessment as soon as possible and by the 26th of March 2020.
In my case, some information was missing to conclude risk assessments for some products. The ‘risk identified’ templates were submitted as a conservative approach to meet the deadline for these products, including a letter to explain risk evaluations were still ongoing.
The deadline was subsequently delayed at the very last minute to the 1st of October 2020 and now to the 31st of March 2021 for chemical medicines.
I have re-submitted Step 1 risk evaluations with the ‘no risk’ template for these products where all information is now available to conclude the risk assessment.
However, I received pushback from one health authority as the risk evaluations can only be submitted once (Q&A question 1.9) and I should proceed to Step 2 – confirmatory testing.
Confirmatory testing does not seem necessary or justified when no risks were identified.
Has anyone had a similar experience and successfully updated their risk evaluations?
Do you have any recommendations on how to raise this with the CMDh?
Thank you for your responses and suggestions