Swissmedic - Swiss Agency for Therapeutic Products
Swissmedic - Swiss Agency for Therapeutic Products
09/01/2025 | Press release | Distributed by Public on 09/01/2025 00:40
Changes to the guidance document Time limits for authorisation applications
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Changes to the guidance document Time limits for authorisation applications
Shortening of time limits for applications for new authorisation of medicinal products with known active substances without innovation under Art. 13 TPA
01.09.2026
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.
- Related documents
Related documents
ZL000_00_014e_WL Guidance document Time limits for authorization applications(PDF, 677 kB, 01.09.2025)
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