Drug database
What to do in case of system failure?
In case of technical failure on SUKL’s side which disables MAH to send ICSRs electronically to SUKL (to ID CZSUKL) this notice will be published on SUKL’s website www.sukl.cz immediately.
It is recommended for MAH to wait for full system function of electronic ICSR interchange with SUKL and not to submit ICSRs during this period. In case that expedited reporting timelines could be overstepped it is possible to send ADR report in an alternative way: to submit reports in xml format on CD media together with completed form Notification of Physical Media Submission due to failure of message receipt by the SÚKL ESTRI Gateway . Reports will be loaded to to SUKLs database manually by SUKLs staff, confirmation of reports receipt will be obtained from SUKL by e-mail. Generated acknowledgement messages will be sent to MAH electronically after restoration of full system function. Reports submitted in this manner will not be re-transmitted to SUKL electronically after full system restoration.
Restoration of full system function will be noticed on SUKLs website as well.
Pharmacovigilance department
19 Mar 2014