What should be done if new information (e.g. related to new potential risk factors or root causes) is identified after the submission of step 1and/or step 2 responses?
Which limits apply for nitrosamines in medicinal products?
N-Nitrosdabigatran with 8 ng/day has been newly added to the table.
What is the approach for new and ongoing marketing authorisation applications (MAA)?
The link to a new risk assessment template to be used in authorisation applications has been added. You will find the template here.
Parallel to the Q&A, the CMDh has updated its practical guidance for MAHs on nitrosamine impurities. It gives detailed answers on
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