Business and industry

Information Authorisations

The new versions of the guidance documents enter into force immediately.

ZL000_00_003e_FO / ZL000_00_001e_WL / ZL000_00_002e_VZ

ZL101_00_002e_WL

Latest market surveillance information

Selected Information

Procedure with prior notification

The Ordinance on Fees now includes the possibility of a "Procedure with prior notification". It makes it possible for an applicant to inform Swissmedic, five to eight months in advance, of the planned submission of an application. Swissmedic then processes the application in a time 20% shorter than for the normal authorisation procedure – with a fee supplement of 100%. The new procedure is applied to new active pharmaceutical ingredients and new applications (two-year pilot phase 2013/2014).