Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to submit their risk assessments for drug products to the authorities before 26 March 2020.
The European medicines regulatory network has agreed to extend the deadline to complete the comprehensive risk evaluation to 1 October 2020, due to the challenges encountered and the impact of the severe restrictions to combat the COVID-19 pandemic.
MAHs should inform the competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. The immediate risk to patients should be assessed and appropriate action taken to avoid or minimise the exposure of patients to nitrosamines.