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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20.01.2020

Notes on using Swissmedic templates for Information for healthcare professionals and Patient information

There are two versions of Swissmedic's templates for Information for healthcare professionals and Patient information for human medicinal products

15.01.2020

Updating of guidance document on authorisation of human medicinal products under Art. 13 TPA HMV4

Changed procedure for "Justified cases" pursuant to Art. 18 para. 2 TPO