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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Changes to the forms for new authorisations of and variations to human and veterinary medicinal products

Information on study design and data sources of RWE in application forms


Modification of the DMF form

Details of a contact for enquiries on the DMF form


Changes to the guidance document Product information for human medicinal products

The detailed Information for healthcare professionals and Patient information templates are being withdrawn