Swissmedic: Requirement for Risk Assessment Relating to Nitrosamines
Swissmedic has established the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.
A new section in the Guidance document Formal requirements clarifies for which new authorisation applications Swissmedic requires a risk assessment relating to nitrosamines in active substances and/or finished medicinal products and what exceptions apply. For example, these risk assessments are always required if the active substance of the human medicinal product to be newly authorised is of a chemical-synthetic nature or contains synthetic components.
The Directory Overview of documents has been supplemented to clarify that Swissmedic expects the risk assessment in Module 1 and for which specific new authorisation applications this requirement applies. These formal requirements also apply in the EU.
The revised versions of the aforementioned specification documents entered into force on 1 May 2025.
Source:
Swissmedic: Authorisations / Information
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