Swissmedic has clarified the submission date for the authorisation application. If the request for implementation of an FTP or a temp.auth. or temp.AI is approved, the authorisation application can be submitted on the planned date stated on the Decision minutes form. At least one month before they intend to submit the authorisation application, however, applicants must confirm to Swissmedic in writing the exact date (exact day) on which they intend to submit the authorisation application (irrespective of the status of the request procedure).
Submission of the Form Meetings for applicants for authorisation procedures is no longer required.
Swissmedic has updated the Guidance documents Fast-track authorisation procedure / Temporary authorisation for human medicinal products accordingly.
These documents will take effect on 1 April 2025