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.