Adaptation of the Guidance document Fast track authorisation procedure HMV4


For FTP applications for medicinal products with ODS received after 1 August 2019, no flat fee will be charged in light of the status (in accordance with FeeO-Swissmedic, Annex 1); however, the FTP supplement will be invoiced (in accordance with Art. 6 FeeO-Swissmedic).

The new version of the affected document enter into force as of 01.08.2019.