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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).