18 June 2025
Swissmedic: Risk assessment relating to nitrosamines in active substances and/or finished medicinal products
Swissmedic now requires a risk assessment for nitrosamines in active substances and/or finished medicinal products for certain new authorizations. The requirements apply for example for products which are of a chemical-synthetic nature or contain synthetic components. Exceptions include radiopharmaceuticals and veterinary medicinal products. The requirements are in line with EU standards.
For more information, see here.
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