State Institute for Drug Control

No, it is not. The sunset clause is always applied on the basis of the Act. SÚKL only has the option to make an exemption from these effects of the Act, if the conditions stipulated by the Act are met (i.e. exceptional circumstances plus always public health protection concern), i.e. SÚKL may decide that the sunset clause provision is not applied, however, only within the scope of an administrative procedure which is governed by the Administrative Code. This administrative procedure may be initiated either by an application submitted by the marketing authorisation holder or by virtue of SÚKL ("ex officio").