6. What about reporting pursuant to the current version of the DIS-13 guideline?

  • Does the DIS-13 reporting system apply also to investigational medicinal products (IMP)?
    Investigational medicinal products (products supplied for the purposes of clinical trials) are exempt from the system of reporting of distributed medicinal products.
  • The price of a sample of a medicinal product with allocated SÚKL code provided to the representatives of the marketing authorisation holder (MAH) in the Czech Republic is zero, what price should be reported?
    The distributor shall report the number of dispensed packages of promotional samples to the marketing authorisation holder or its sales representatives specifying the price as the amount of 0.00 CZK.
  • A medicinal product – non-authorised, intended primarily for mail-delivery dispensing abroad, i.e. in a specific packaging: should such sale be reported pursuant to the DIS-13 guideline?
    No, this medicinal product should not be reported, as it is not intended for the market in the Czech Republic.
  • The sending of reporting data will be possible only for authenticated and authorised clients on the basis of allocated access codes. How can these be obtained?
    SÚKL will send the workplace identifier and access codes to all distributors as a bulk postal delivery. It will contain the account and access password.
  • Will a web form for sending of reports be available for those distributors?
    After the workplace identifier and access codes are sent, information on the web form for the entry of supply reporting will be also sent. The form is intended particularly for distributors who do not have the possibility to send .xml file for sending of supply reports.
  • What should I do if I wish to amend a previously sent report because an error has occurred?
    Until the 20th day of the month it is possible to send an amended report with valid data for the previous month.
  • Is it possible to send the report additionally, after the established timeline of the 10th day of the month has expired?
    Unfortunately, it is not possible to send the report after the 10th day of the month. Only an amended report may be sent after the 10th day of the month (until the 20th day of the month).

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