The content and wording of the guidance documents Fast-track authorisation procedure HMV4 and Temporary authorisation of human medicinal products HMV4 have been revised in order to more clearly describe the criteria for using and distinguishing between the two procedures. In the annexes to the guidance documents, decision trees have been added to clarify the criteria and the key issues.
The changes should create transparency with regard to Swissmedic's eligibility criteria and make it easier for companies to choose the right procedure.
The revised guidance documents enter into force on 1 November 2020.