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.
The Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products have been revised accordingly and the new versions are valid with immediate effect.