It means the first entry of the medicinal product onto the market following the completion of manufacture, i.e. entry into the distribution chain beyond the control of the MA holder. In lay terms, it is the moment as of which the manufacturer completes manufacture and hands the medicinal product over to the distributor.
The marketing authorisation holder is obliged to notify SÚKL of the placement of a medicinal product onto the market (as set forth in Section 33, paragraph 2 of the Act on Pharmaceuticals), using an electronic form which is available from SÚKL's website – see http://www.sukl.cz/modules/marketreport/edit.php?lang=2.
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