As a precaution, the European Medicines Agency (EMA) and European medicines authorities asked marketing authorisation holders in October 2019 to perform a risk assessment on the presence of nitrosamines.
The Federal Agency for Medicines and Health Products (FAMHP) has published a guidance on reporting the risk assessment for NPs, DCPs and MRPs online.
In case of no risk, a template must be completed and sent to the FAMHP using this web form. However, if a risk of presence of nitrosamines is identified, another template and an Excel file must be completed and sent to the FAMHP using this web form.
The FAMHP notifies that an additional step is required for DCP and MRP procedure products. The completed template and Excel file must also be sent to all affected member states.
Results of the risk assessment can be reported until 26 March 2020.