Changes to guidance document Fast-track authorisation procedure and guidance document Temporary authorisation for human medicinal products

Exchange of documentation for the AAA now possible via the eGov portal


Submission of the decision minutes and presentation slides for the AAA is now possible via the eGov portal. The applicant now has a deadline of 3 working days after the AAA to finalise the decision minutes. As submission is via the eGov portal, the decision minutes do not require signatures.

Swissmedic has updated the specification documents accordingly. The revised documents are valid as of 1 June 2023.