Notification of Changes in the reporting of deliveries of distributed medicinal products under Guideline DIS-13, version 5

SÚKL draws attention manufacturers and distributors to some important changes concerning the reporting of deliveries of distributed medicinal products under Guideline DIS-13, version 5, in effect from 1 September 2017:  

  1. For both submitting methods of reporting, i.e. through the data interface and via the web form, it is necessary to use a certificate that each reporting entity generates itself at https://pristupy.sukl.cz/index_en.html , section External Identity
  2. For access to certificate issuing can be used an earlier assigned logins. More detailed information is available on https://pristupy.sukl.cz/documents/ei_navod_aj.pdf
  3. Without installing a certificate into the information system of the entity, which submits a report, either communication with the data interface or an insertion of data into the web form is not possible and an error message is displayed to the user.
  4. Access to the web form for report submission is possible directly from the portal Pristupy, section Reports for SÚKL, or via address https://api.sukl.cz/dis13_forms.html. A web browser Google Chrome is recommended for accessing the form.
  5. The reporting of deliveries of distributed human medicinal products must be entered no later than 10th day of the month following the month, for which the reporting is submitted. This is the change in deadline compared to the substitute reporting system used until August 2017, where the deadline was by 15th day.
  6. If the entity, which is obliged to report, does not enter the report by the 10th day of the month, it is no longer able to enter this report. In the period from 11th to 20th day of the month the entity can request the Institute’s Data analyses department to enter a declaration of non-distributing. This request can be done only electronically at an email address oda@sukl_cz . The declaration of non-distributing entered in this way can be edited and completed by the reporting entity no later than 20th day of the month.
  7. After this date, i.e. from the 21st day of the month, it is possible to use the possibility of extraordinary correction of the report, in the Guideline DIS-13, version 5, named as “Report updating”, which is subject to control and approval by SUKL. An extraordinary correction is a part of the form and the data interface and cannot be done in any other way.
  8. For any questions and technical issues is possible to use the following contacts:
  • solving technical issues related to reporting itpodporahlaseni@sukl_cz
  • queries on the content of the reporting under Guideline DIS-13, version 5  oda@sukl_cz
  • queries to a certificate generation pristup@sukl_cz

For communication with the administrators of information systems and SW companies is set the contact center https://kc.sukl.cz, for its use it is necessary a previous registration at registracekc@sukl_cz.

 

GDP department

22. 2. 2018