If the medicinal product has lower consumptions and it could be jeopardised by the sunset clause, it is in the interest of the marketing authorisation holder to report the date of the first placement onto the market after December 31 2007. The 3-year period during which the medicinal product must be present on the market in sufficient amount shall commence on this date. In the case SÚKL has no date of placement onto the market after December 31 2007, and consumptions of this medicinal product are reported in 2008, SÚKL shall consider January 01 2008 the date of placement onto the market following the coming into force of the Act on Pharmaceuticals.
If the medicinal product has sufficient consumptions and it is not likely to be jeopardised by the sunset clause, it is not necessary to report the placement onto the market following the coming into force of the Act on Pharmaceuticals.
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