Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications
Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation)
Explanations regarding dispensing category classification and clarification of the requirements for the application documentation for authorisations according to Art. 14 para. 1 letter abis-quater TPA
