Reporting on the placing on the market, interruption, termination and renewal of the supply of a medicinal product
Description
According to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, marketing authorisation holders are obliged to notify the State Institute for Drug Control (SÚKL) of the placing, interruption or termination and subsequent renewal of the supply of the medicinal product on the Czech market. The dataset shall contain the aggregated data reported pursuant to the first sentence of Section 33(2) on the placing on the market, interruption or termination of the placing on the market of the medicinal product in the Czech Republic.