Nitrosamine - Step 1 risk evaluation updates

Dear Colleagues,

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


1 Like

Hi Julien,

Thanks for sharing your experience, I agree you shouldn’t have to move to confirmatory testing where no risk has been identified, nor should an agency expect you to.

A number of competent authorities put their own submission processes in place alongside the EMA/CMDh process. Concerns were raised about this by EFPIA but fell on deaf ears I think. You say you have received push back from one health authority, is the issue here with the national competent authority and were they using their own bespoke submission process rather than with EMA/CMDh? This might mean CMDh wouldn’t need to be involved and might not thank you for doing so?

Best regards,


Hi Gair,

Thank you for your response. The Health authority pushing back is referring to the CMDh Q&A below and therefore saying they are following the CMDh process agreed across EU countries. See Q&A screenshot below.

This CMDh question 1.9 suggest that no updates to risk evaluations can be made and MAH should proceed to confirmatory testing.