6. What are the requirements for reporting of the volumes of distributed medicinal products (DIS-13 report)?

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?
Yes, in both cases the distributor would commit an offence and may be penalised for such breaches. In case the distributor fails to submit the report as referred to under the DIS-13 guideline, it constitutes an offence referred to under the provision of Section 103(6)(c) of the Act on Pharmaceuticals, and, pursuant to Section 107(1)(b), the distributor may be subjected to a fine amounting up to 300,000 CZK. If the distributor provides incomplete or inaccurate data on the supplies of medicinal products in the report referred to under the DIS-13 guideline, it constitutes an offence referred to under the provision of Section 105(2)(i) and, pursuant to Section 107(1)(d), the distributor may be subjected to a fine amounting up to 5,000,000 CZK.