On 1 May 2025, Swissmedic published a notice on its website stating that the ‘Table of Documents to be submitted’ had been updated to include item 1.12.5, and that Swissmedic now expects the risk assessment to be submitted in Module 1.

https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/informationen/risikobewertung-nitrosaminen-in-ws-am.html

However, implementing this requirement as part of an eCTD submission is difficult, as there is currently no Section 1.12.5 in the Swiss eCTD Module 1. Updating the Swiss eCTD Module 1 specification, which is being completely rewritten as part of the transition to eCTD Version 4.0, is complex and time-consuming. Its implementation is expected to become mandatory for Switzerland in 2030.

Therefore, for an eCTD submission, the nitrosamines risk assessment documents must continue to be submitted/filed under ‘Additional Information’. Alternatively, the documents may also be filed under CTD Chapter 3.2.P.5.6 (Justification specification), but this must be mentioned in the cover letter.

Nitrosamine Risk-Assessment