Category Guidance document

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

The processes for the following have been optimised: Normally, if the criteria for an FTP or a temp.auth. / temp.AI cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic, an Accelerated Application HeAring (AAA) usually takes…

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