Changes to the guidance document Temporary authorization of human medicinal products

19. Januar 2024 – One key criterion to be met is that there is no authorised, alternative and equivalent medicinal product available in Switzerland (Art. 9a para. 1 let. C of the Therapeutic Products Act (TPA) or Art. 18 let. b of the Therapeutic Products Licensing Requirements Ordinance (TPLRO)). Swissmedic clarified this term. The criteria for assessing the equivalence of medicinal products include the indication, the target population to be treated, the mechanism of action, the ease of use, and the risk-benefit profile. In addition, the process for applying for a temporary authorisation has been optimised. Differing processes will be employed in future, based on the result of the assessment of the documentation submitted with the application for a temporary authorisation procedure.

The guidance document Temporary authorisation for human medicinal products has been amended accordingly in sections 5 and 6 and Annexes 1 and 2, and is valid from 15 January 2024.

For more information, see here.