Changes to the Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

20 janvier 2023 – The deadline for finalising the decision minutes has been extended. The decision minutes can be finalised by the applicant following the Accelerated Application Hearing (AAA) and sent to Swissmedic on the next working day after the hearing. In addition, documentation for the AAA can now be exchanged via the eGov portal with immediate effect.

For more information, see here.