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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01.09.2022

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

Clarification of safety-relevant updates to medicinal product information for authorisations according to Art. 14 para. 1 let. abis TPA

16.08.2022

Benchmarking study 2021

International comparison of Swiss approval times

01.08.2022

Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Filing of Submission Plans to evaluate the efficacy of existing COVID-19 medicinal products against new SARS-Cov-2 variants