Medicinal products with orphan drug status

Eligibility for procedure with prior notification and modification of billing practice for fast-track authorisation procedure


Procedure with prior notification available for medicinal products with orphan drug status from 1 August 2019

Until now it has not been possible to apply the procedure with prior notification (PPN) to medicinal products with orphan drug status (ODS). Since its introduction in 2013, the procedure has been continually optimised in partnership with the industry. In the light of the experience gained, Swissmedic is now changing its practice and will be opening the PPN to applications for ODS as of 1 August 2019.

Although no flat fee is charged for first-time authorisation of ODS products (Art. 9 FeeO-Swissmedic, SR 812.214.5), the PPN supplement (Art. 7 FeeO-Swissmedic) will be invoiced for ODS in accordance with the pay-for-performance principle.

Medicinal products with orphan drug status in the fast-track authorisation procedure

Consequently, the pay-for-performance principle will in future also be applied to the fast-track authorisation procedure (FTP). No flat fee will therefore be charged for FTP applications for ODS received after 1 August 2019; however, an FTP supplement will be invoiced in accordance with Art. 6 FeeO-Swissmedic.