Specific requirements for the reports originated in CZ:

4.1 Case narrative in reporter’s native language

For ICSRs from the Czech Republic sent to the EudraVigilance database it is required by SÚKL to provide information on Case narrative and Reaction/Event as reported in native reporter’s language in case they are available to MAH. Such information should be given in the form of verbatim text according to the report source documents in appropriate E2B (R3) fields (Case Summary and Reporter’s comments Text (H.5.r.1a) and Reaction/Event as reported by the Primary Source in Native Language (E.i.1.1a). It is also important to add the language codes to both fields. – in H.5.r.1b and E.i.1.1b fields.

The obligation to fill in case narrative in the native language of the reporter (field H.5.r.1a Case Summary and Reporter’s Comments) does not apply to reports from the literature. In this case, a literature article is considered as a sufficient description of the case in the native language; it is not necessary to include it or its summary in the report.

The obligation to fill in the reactions as reported by the reporter (field E.i.1.1a Reaction / Event) in the native language of the reporter, however, still applies to reports from the literature.

The requirement is based on EU ICSR Implementation Guide document, I.C.3.4 Use of local Language in Reaction/Event section and Case Summary section.

4.2 Literature article submission to SÚKL

In accordance with GVP Module VI, SÚKL can ask the MAH which transmitted to EudraVigilance the initial ADR report originated from scientific literature (where the occurrence country or the primary source country is the Czech Republic) to provide a copy of the source literature article.

The article is sent to the person who requested it in the format available to MAH as an e-mail attachment, and in a copy to the address: farmakovigilance@sukl.cz.

4.3 Follow-up request

SÚKL accepts MAHs’ follow-up (FU) requests to the reports which have been sent to EV system by SÚKL. Requests have to be always substantiated, SÚKL with reference to the GVP Module VI will not accept routine FU requests.

The following situations are covered in as reasons for FU process initiating:

• important additional information is necessary for case evaluation or reconciliation
• clarifications are needed regarding inconsistent data within ICSRs
• there is a need to obtain further information in the context of the validation of a signal, the evaluation of a safety issue and so on

The FU request is to be sent by e-mail to the e-mail address farmakovigilance@sukl.cz

The request has to contain worldwide unique case identification number of the report which is going to be followed-up; it has to include the justification for this request; it has to be sent in the form of clearly formulated questions. It must not contain repetitive questions to facts which have already been stated by the reporter in the ICSR. The requests in the form of a questionnaire will also not be accepted. In the case SÚKL obtains the requested information from the reporter, follow-up is processed by SÚKL, the ICSR is sent to EV database only and will thus be available to the MAHs.

On the other hand, MAH could be asked by SÚKL to follow-up the ICSR which has been sent to EV database by the MAH, in reasonable cases described above. For that purpose, SÚKL will contact MAH’s contact person for pharmacovigilance issues. The elaborated FU is submitted directly to the EV database by the MAH, FU is going to be re-routed to SÚKL by EMA afterwards.