In addition to the recent update of the EMA Nitrosamine impurities related to the extension of Step3 deadline, Step2 template of no nitrosamine was updated.
The following option and footnote were added in the template to change the conclusion “risk” in Step1 to “no risk” by new/additional information (not confirmatory testing).
☐ for the product Name, Active Pharmaceutical Ingredient, Marketing Authorisation Number, EU Procedure Number (for MRP/DCP products only), Step 1 outcome is amended to „no risk“ due to new/additional information received from e.g. the API or excipient manufacturer and under consideration of all root causes and the published guidance1.
Footnote1: In exceptional cases due to the availability of formerly missing data, a correction of step 1 outcome from “risk” to “no risk” is accepted. With ticking the box you confirm that the correction is made due to exceptional cases where data was missing at the March 2020 deadline and is now available. This tickbox may not be used for changes of step 1 outcome from “no risk” to “risk”. In these cases you are required to proceed without delays with Step 2 confirmatory testing and, as applicable, Step 3 submission of required changes to the Marketing Authorisation in accordance with the published guidance.