1 March 2026

Swissmedic has revised the Guidance document Authorisation human medicinal product under art. 13 Therapeutic Products Act (TPA), making editorial adjustments and clarifying the wording in several chapters. These changes, however, do not constitute any amendment to the application requirements. The associated form has also been updated. The revised Guidance and form are to be applied from 1 March 2026.

For more information, see here.