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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01.10.2020

Swissmedic extends the MAGHP procedure

The new Light procedure builds on the established MAGHP procedure, but is explicitly applicable to applications for the fast-track authorisation procedure and for temporary authorisation