35. In case a medicinal product packaging in the form of a foreign-language batch is placed on the market, will that be also considered placement on the market for the purposes of Sunset Clause?

If a medicinal product packaging is placed on the market in the Czech Republic as part of a foreign-language batch approved by the Institute in compliance with Section 38 of the Act on Pharmaceuticals (for more information on foreign-language batches, please refer here), such placement on the market shall be considered placement on the market in the Czech Republic for the purposes of Sunset Clause, i.e. as per the provisions of Section 34a(1) or (2) of the Act on Pharmaceuticals. Please note that in such a case it is necessary to report such placement on the market in compliance with Section 33(2) of the Act on Pharmaceuticals via a web form available from here.