Section 2.5.16 Risk assessment relating to nitrosamines in active substances and/or finished medicinal products has been added to the Guidance document Formal requirements.
This section 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. New authorisation applications for radiopharmaceuticals, veterinary medicinal products or, for example, co-marketing medicinal products are exempted from the requirement to submit nitrosamine risk assessments.
In the “New authorisation” section of the Directory Overview of documents to be submitted, item 1.12.5 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 enter into force from 1 May 2025.