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 Mobile technologies and the related form

Training documents according to the most recently approved RMP are considered to be information required by therapeutic products legislation


Modifications to guidance document Formal requirements

Clarification on submission via eDOK and eCTD for co-marketing medicinal products


Changes to the guidance document Temporary authorisation of human medicinal products

Clarification regarding authorised medicinal products, harmonised deadlines for applications before expiry of temporary authorisation and changes to terminology