Swissmedic - Swiss Agency for Therapeutic Products
Swissmedic - Swiss Agency for Therapeutic Products
03/01/2026 | Press release | Distributed by Public on 03/01/2026 04:27
Changes to the Guidance document Authorisation human medicinal product under Art. 13 TPA
Changes to the Guidance document Authorisation human medicinal product under Art. 13 TPA
Update of the Guidance document Authorisation human medicinal product under Art. 13 TPA
01.03.2026
Swissmedic has revised the Guidance document Authorisation human medicinal product under Art. 13 TPA, and in addition to editorial changes, the wording has been made more precise in various sections. The changes made do not constitute changes to application requirements under Art. 13 TPA. The form Information for application Art. 13 TPA HMP has also been made more precise in the same sections as in the Guidance document.
The revised Guidance document Authorisation human medicinal product under Art. 13 TPA and the form Information for application Art. 13 TPA HMP come into effect from 1 March 2026.
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