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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26.03.2020

Election of the Swissmedic Medicines Expert Committees (SMEC) for the 2021-2024 term of office

Independent experts as an additional quality-assurance element in the authorisation process

01.02.2020

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

The new version of the guidance document enters into force on 1 February 2020.