Important notice on the obligation of reporting data on medicinal product utilisation to HALMED
09.02.2016
Under the Medicinal Products Act (Official Gazette No. 76/13, 90/14) and the Ordinance on the Type of Data and Manner of Drafting the Report on Medicinal Product Consumption (Official Gazette No. 122/14), all natural and legal persons engaged in wholesale distribution of medicinal products and legal or natural persons engaged in retail sale of medicinal products are obliged to submit annual reports on medicinal product utilisation to Agency for Medicinal Products and Medical Devices (HALMED).
In accordance with the above, we would like to highlight some important information related to the reporting of data for the previous year:
- Reports should be submitted to HALMED electronically via the Farmakoekonomika application.
- Data required for access to the application are: reporter’s code, username and password. When accessing the application, the same identification data are used as in previous years, which are still valid, unless data about the reporter - based on which identification data are assigned - have been changed in the meantime.
In case of any questions concerning these data, you may send your enquiry to the e-mail address info.potrosnja@halmed.hr. - Reports for the year 2015 should be submitted to HALMED by 31 March 2016.
- The following data are reported to HALMED: reporter’s code, year for which data are reported, medicinal product code, number of sold packs, number of sold packs that are reimbursed by the Croatian Health Insurance Fund (wholesalers report their data as "NOT reimbursed by the Croatian Health Insurance Fund”), wholesale price of an original pack.
- Wholesale price reported for a particular medicinal product is the wholesale price of an original pack that was valid on 31 December 2015.
- Wholesalers report their data on utilisation without including turnovers realized through sales to other wholesalers in the total turnover they report, whereas the entire remaining turnover should be reported.
Wholesalers that realize their turnover exclusively through sales to other wholesalers and do not deliver medicinal products to their place of dispensing to end users do not have to submit reports to HALMED. The data on utilisation of medicinal products delivered to the Croatian Institute of Public Health based on public tenders should be reported. - The codebook to which reporter’s codes should be matched is available at HALMED's web service:
http://ws.halmed.hr/ws/FarmakoWS.php. - The reporting procedure is not completed until all the reporter’s data have been matched with HALMED’s codes. In the case that some data do not get matched, reporters should contact HALMED's staff so that difficulties are investigated and remedied, and the receipt of data can be completed.
For further questions and in case of possible difficulties in the reporting, reporters may contact HALMED via the e-mail address info.potrosnja@halmed.hr as well as phone numbers 01 48 84 341 and 01 48 84 342.
