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.

Informations

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01.10.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Preliminary Decision Clarification Meeting for human medicinal products to be introduced

01.09.2025

Disposal information to be added to Patient information

Change to the Guidance document Product information for human medicinal products

01.09.2025

Revision of the guidance document Formal requirements

Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025