Method and particulars of reporting

An electronic report shall mean an individual case safety report in the format defined by the ISO ICH E2B(R3) guideline, the individual items of which are described by the ICH ICSR M2 guideline and E2B(R3) Implementation Guide. Reports which do not comply with this definition shall be, for the purposes of this guideline, referred to as non-electronic reports, even if they are sent electronically (e.g. by e-mail).

Electronic reporting is defined as the transfer of the ichicsr message in the xml format between the sender and recipient using the EudraVigilance system, and subsequent transfer of the Acknowledgement (ACK) from the recipient to the sender. The ACK format is also defined by the ICH M2 guideline and E2B(R3) IG. Electronic report submission is considered successful and completed only if the sender of the message or report receives an ACK in the correct format showing the value of AA – CA.

Since 22 November 2017 (the date of the new EudraVigilance system go-live) all ADR reports received from HCPs or consumers by SÚKL are sent to EudraVigilance database from the production ID CZSUKL in accordance with the rules given by the Pharmaceuticals Act § 93c (3) as follows:

• All CZ serious reports: Within 15 days after report receipt
• All CZ non-serious reports: Within 90 days after report receipt

Since 22 November 2017 SÚKL has not resent any ADR reports received by SÚKL from HCPs or consumers to MAHs. These reports are available for MAHs in EudraVigilance database in the extent given by EV Access Policy.

At the same time since 22 November 2017 SÚKL has not accepted any ICSRs sent by MAHs, MAHs submit their ICSRs directly to the EV database (to ID EVHUMAN for reports to EVPM module and to ID EVCTMPROD for reports to EVCTM module) within the scope of the centralised reporting. These reports are obtained by SÚKL using the EMA re-routing function.

When processing reports which are originated in CZ and are submitted to the European database in accordance with §93a (2) of the Pharmaceuticals Act, SÚKL shall apply all the rules for their processing and quality assessment as specified in GVP Module VI (the version in force).

According to guideline PHV-6 MAH is obliged to appoint a contact person for pharmacovigilance issues in the Czech Republic. Their primary responsibility is to ensure communication with SÚKL, including in the area of ICSR reporting, the contact person for pharmacovigilance issues is the primary contact for issues related to ICSR reporting from the Czech Republic (ICSR data quality issues, technical problems, follow-up requests from SÚKL).