Authorisations

Information Human medicines

The new versions of the guidance documents enter into force immediately.

ZL000_00_003e_FO / ZL000_00_001e_WL / ZL000_00_002e_VZ

ZL101_00_002e_WL

Authorisations

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. This work is supported by targeted, experimental analysis by the Swissmedic laboratories.

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.