Pursuant to Section 77(1)(f) of the Act on Pharmaceuticals, the distributor is obliged to regularly submit to the Institute complete and accurate reports of the volumes of distributed medicinal products. The structure of the data, form, method, and time intervals of the provision via electronic reports are stipulated by Section 35b of Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals. Furthermore, distributors may be guided by the current version of guideline DIS-13, which is of the nature of a recommendation and describes, inter alia, technical information about the reporting system.
For more details on the DIS-13 report, please refer to the reporting portal at pristupy.sukl.cz.
- Can a distributor be penalised for failure to submit the DIS-13 reports or for provision of reports with inaccurate data?