6. We notified market introduction of the medicinal product before the Act on Pharmaceuticals became effective (31 December 2007). Are we obliged to notify this again?
Should a medicinal product be jeopardized by the sunset clause, it is in the best interest of the marketing authorisation holder to notify of the date of the first market introduction after 31 December 2007. The period of 3 years in which the medicinal product must be available in the market in a sufficient amount, shall commence on the first day of the year following the year in which this medicinal product was introduced to the market in the Czech Republic . If SUKL does not have the date of market introduction after 31 December 2007 and if consumption of this medicinal product is notified in 2008, SUKL will consider the date of 1 January 2008 to be the date of market introduction after the Act on Pharmaceuticals has become effective.