Nitrosamines Risk Assessment - EMA

Following the detection of nitrosamines in sartrans and in ranitidine medicinal products, in September 2019 EMA requested all MAHs to perform a risk assessment of all drug products containing chemically synthesised active substances to identify the risk of nitrosamines contamination. EMA issued an informative document indicating the steps for demonstrating absence of nitrosamines and/or for updating the marketing authorization.

In a Q&A document on this topic, EMA clarified that the above-mentioned risk assessment is also applicable to new marketing authorization applications.

All the documents and information related to this topic are available here, on EMA website.