Authorisations of human medicines

Within the framework of the authorisation procedure, Swissmedic assesses the quality, safety and effectiveness of the medicinal product in question on the basis of the comprehensive scientific documentation that is submitted.

If the criteria for authorisation are fulfilled, Swissmedic grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.


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Voluntary prior notification of new applications with new active substance for human medicinal products

Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications


Changes to guidance document Authorisation of human medicinal product with known active pharmaceutical ingredient

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)


Changes to the guidance document Temporary authorisation of human medicinal products

Clarification of the term "equivalent medicinal product" and timing of criteria assessment for temporary authorisation