Nitrosamines alert: update from the European medicines regulatory network

The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) as described in information on nitrosamines for marketing authorisation holders (MAH) to 1 October 2020 due to the impact of the severe restrictions in place to combat the COVID-19 pandemic.

In any case, the European medicines regulatory network encourages MAH to submit the outcome of step 1 before 1 October 2020 if they complete the risk evaluation and/or identify a risk in their products.

Mérieux NutriSciences and its qualified partners provide a valuable support at all process stages, from risk assessment to test implementation in order to verify the absence of nitrosamine impurities and ensure the safety of pharmaceutical products.