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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03.07.2020

A study confirms Swissmedic’s international Competitiveness

In an international comparison of the processing time for scientific assessments, Swissmedic is on a par with the fastest authorities

01.07.2020

Optimisation of labelling phase for human medicinal products

Avoiding text review rounds