4. Will a list of pharmaceuticals to which the sunset clause might apply be available? What information will it contain?

SÚKL has prepared an overview of medicinal products which to date have no reported consumption or which do not comply with the requirements of the Decree, i.e. not more than 10,000 DDDs nor at least one package have been distributed during the concerned period. This overview is available from SÚKL's website at http://www.sukl.cz/sunset-clause-a-list-of-medicinal-products. The overview contains basic information about the product – name of the product, pharmaceutical form, MA number, ATC code and the marketing authorisation holder.
SÚKL emphasises that the overviews are of informative nature only. Should the marketing authorisation holder identify any discrepancies, SÚKL kindly requests the holder to contact SÚKL, ideally by email. Any statement must be always supported with evidence.