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.
There is an inconsistency between the items of the body of the report and the text of explanation under the table in section 1.2.2, item 5.
Yes, as part of a revision, the text will be amended as follows:
“Quantity – the quantity of number of packages of the medicinal product of the concerned batch“
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 who will not have the possibility to connect their information systems directly to the communication interface?
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 small distributors who do not have the possibility to connect their software directly to the communication interface for sending of supply reports.
What are the details of access via the VPN tunnel?
For those distributors who will access the communication interface for supply reporting via the VPN connection, it will be possible to organise a secured connection service via a SÚKL subcontractor. The technical parameters of HW equipment and connection will be available upon request.
- What are the alternatives of sending data to SÚKL and which of them should be selected?
- The generated file is transferred to the data repository in SÚKL via the secured VPN connection. This method is intended for connecting the user's SW to SÚKL's communication interface. Preferred alternative.
- Data are sent manually via the web form and subsequently they are sent to the data repository. An alternative suitable for smaller distribution entities. Authentication will be required upon sending of the report.
How is the VPN tunnel going to be secured?
The VPN connection will be secured via the IPsec (IP Security) protocol in the tunnel mode with the IKEv2 (Internet Key Exchange) support. More details are available upon request.
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).
Does SÚKL plan any information briefing for the suppliers of my SW?
Yes, a meeting of the project authors with representatives of manufacturers of distribution companies´ SW is planned for early February 2011.
Will it be possible to test or try out the sending of the report?
Test environment allowing for test operation will be available to suppliers of SW for distribution entities and to users who will communicate via the web application.
How are returns going to be monitored in the monthly reporting cycles?
The project design allows for independent monitoring of both supplies and returns. The turn of the month is no barrier.
DIS 13 - version 4, 31 December 2010
Reporting of supplies of distributed human medicinal products