19. Do I understand it well that the sunset clause shall either apply upon statutory requirements or upon request?
No. The sunset clause shall always be applied only by law (see Question 19). SUKL may only lift these effects of the law, e.g. it may decide upon fulfilment of statutory requirements (e.g. there must be exceptional circumstances and public health protection must always be taken into account or rights of third parties must be at stake) that the sunset clause shall not apply. However, this may only be decided within an administrative procedure pursuant to the Administrative Code. This administrative procedure may either be initiated by an application filed by the marketing authorisation holder or on its own initiative. SUKL may decide upon non-application of the sunset clause only in cases stipulated by law (public health protection, e.g. if an irreplaceable medication is concerned; rights of third parties – e.g. granting of sufficient protection period for the originator).
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