4. What does a launched medicinal product mean?
For the purposes of Section 34a (1) of the Act on Pharmaceuticals, a market launch shall be the first market introduction of a medicinal product after termination of production, pursuant to Section 3a (10) thereof, i.e. introduction to the distribution chain. In simple words, it is the point when the producer finishes production and gives the medicinal product to the distributor. The marketing authorisation holder shall be obliged to notify SUKL (pursuant to Section 33 (2) of the Act on Pharmaceuticals) of market introduction of the medicinal product by means of an electronic form which is available on the SUKL website, see http://www.sukl.cz/hlaseni-uvedeni-preruseni-nebo-ukonceni-uvadeni-na-trh , within two months after the actual market introduction at the latest. For the purposes of Section 34a (2) of the Act on Pharmaceuticals, market introduction shall be every following market launch of medicinal product pursuant to Section 3a (10) thereof.