One of our customers has received an inquiry from a National Authority regarding the Leading Member State (LMS) position on the assessment of the nitrosamine impurity of a product. I had previously heard comments that the EMA was designating different countries as references for managing the most problematic nitrosamine AIs/interim limits.
But the only reference I have found to these Lead Member State is in the “Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines” Published 29/07/2025
Has anyone else had a similar request?
Can anyone confirm or deny this initiative? Is there a way to know which member state is responsible for each molecule?
See CMDh_431_2021_Rev.1_2023_04_-_Nitrosamine_assessment_outcome_step_2_template.docx The lead member state is in principle the one completing the CMDh/431/2021 Nitrosamine Risk assessment Assessment Report Preliminary Outcome step 2 and identifying itself as such based on the template preamble. It was originally a mechanism in the network to divide the assessment report activities of Step 2.
Thank you for your help.
Is there a way to find out, for a specific product, which country completed the CMDh/431/2021 Nitrosamine Risk assessment Assessment Report Preliminary Outcome step 2 first and has therefore been identified as the Lead Member State for that molecule?
