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 guidance document Authorisation of human medicinal products under Art. 13 TPA

Application of Art. 13 TPA possible for temporary additional indications


Changes to the Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

Extension of the time limit for finalising the decision minutes. Exchange of documentation for the AAA now possible via the eGov portal.


Changes to SwissPAR HMV4 guidance document

Section 5, Clinical Assessment, of the Public Assessment Report is not part of the SwissPAR