Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active substances without innovation (KAS w/o innovation) under Art. 13 TPA.
This change is part of the continuous development of the procedure under Art. 13 TPA. The new time limits shorten the procedure for applications for new authorisation of KAS w/o innovation under Art. 13 TPA by a total of 195 days. The new procedural time limits will help further enhance the appeal of applications for authorisation under Art. 13 TPA.
Swissmedic has revised the guidance document Time limits for authorisation applications accordingly. The new time limits for applications for new authorisation of KAS w/o innovation under Art. 13 TPA will take effect on 1 September 2025.