Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents.
- The guidance document Formal Requirements is supplemented by Chapter 2.5.16 Risk assessment regarding nitrosamines in active substances and/or finished medicinal products .
- This document specifies for which new marketing authorisation applications, Swissmedic requires a risk assessment of nitrosamines in the active ingredient and/or finished medicinal product, and which exceptions apply.
- For example, these risk assessments are always required if the active ingredient of the newly approved human medicinal product is chemically synthetic or contains synthetic components.
- New marketing authorisation applications for co-marketing medicinal products, for example, are exempt from the requirement to submit nitrosamine risk assessments.
- In the “New Marketing Authorization” tab of the list of documents to be submitted , the added item 1.12.5 also clarifies that Swissmedic expects the risk assessment in Module 1 and to which specific new marketing authorization applications this requirement applies.
- These formal requirements also apply in the EU.
- The above-mentioned standard documents entered into force in an adapted version from 1 May 2025.
Update 18 June 2025
- The documents for the nitrosamine risk assessment should preferably be submitted as Additional Information in Module 1.
- CTD does not have a Chapter 1.12.5. Alternatively, placement in CTD Chapter 3.2.P.5.6 ( Justification of Specification ) is also acceptable.
- In this case, the placement must be indicated in the accompanying letter.
Source: Swissmedic