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Reporting requirements

Obligations concerning the reporting of post-authorisation adverse drug reactions in Hungary

This communication supersedes all previous documents on the electronic reporting requirements of post-authorisation adverse drug reactions in Hungary, and is valid from 22 November 2017.

1. Guidance documents

Further to the legal background summarised in the general introduction on pharmacovigilance, more guidance may be obtained from the sources listed below:

· Guideline on Good Pharmacovigilance Practices Module VI, Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)

· European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use

2. Electronic reporting of spontaneous individual case safety reports (ICSRs) and reports from non-interventional studies

MAHs need to submit electronically to EV Post-Authorisation Module (EVPM; ID EVHUMAN) information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the MAH concerned gained knowledge of the event.MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the MAH concerned gained knowledge of the event.

MAHs should no longer submit ICSRs directly to NCAs, including OGYÉI.

As for suspected adverse drug reactions reported to OGYÉI by the primary source, OGYÉI transmits these ICSRs directly to EVPM in accordance with simplified reporting modalities. MAHs need to use EVWEB functionalities to obtain access (and to download) reports of suspected adverse reactions which are reported by NCAs to EVPM. OGYÉI does not send ICSRs directly to MAHs.

Invalid cases not resulting in an adverse drug reaction, but with potential relevance for drug safety (e.g. mix-up of vaccines) are transmitted to the local pharmacovigilance contact of the MAH via email by OGYÉI.

Please note that reports sent by NCAs (including OGYÉI) to EVPM shall not be re-submitted. If (re)submission is deemed necessary, please consult Pharmacovigilance Department in advance. In case of submission of follow-up reports of the concerned cases, please do not change the worldwide unique case identification number (C.1.8.1 and C.1.8.2) given by the NCAs in order to avoid generation of duplicate reports in EVPM.

3. Investigation of vaccine reports

According to an agreement between OGYÉI and the National Public Health Centre (NNK), investigation of vaccine related adverse events are exclusively carried out by NNK and its regional administrative bodies in order to rationalise the use of resources and avoid unnecessary duplication of work. The Institute does not perform any follow-up in such cases. NNK immediately notifies OGYÉI on every adverse event experienced following immunisation which may mean the availability of only limited amount of data. At this early stage, rapid initiation of an investigation is the primary goal, not provision of exhaustive information. Later on, when available, NNK notifies OGYÉI on the detailed result of the investigation; however, this might take some time. OGYÉI will get involved in the investigation only if based on the initial data, prompt regulatory action is required to protect public health.

4. Literature cases

MAHs are required to regularly monitor the scientific literature, in particular articles published by Hungarian journals. Medical literature monitoring is needed for all active substances for which the MAH holds valid marketing authorisation in Hungary and is actually launched on the Hungarian market. With the introduction of medical literature monitoring by the EMA in 2015, monitoring and reporting obligation ceased for certain active substances and literature sources followed by the EMA. However, MAHs shall continue monitoring all other medical literature and follow all active substances not covered by the medical literature monitoring service of the EMA and report any suspected adverse reactions from these sources. Further details about the lists of active substances and medical literature followed by the EMA are found at theAgency’s website.

Please note that the Institute does not publish a list of recommended scientific journals or other literature sources to be monitored in Hungary. Identification of relevant sources and continuous monitoring is the responsibility of the MAHs, taking into consideration also the lists of active substances and literature sources monitored by the European Medicines Agency.

Literature articles may be attached directly to the ICSRs (if transmitted as E2B(R3) XML files). For this reason, OGYÉI does not request MAHs to submit literature articles that serve as a source of valid ICSRs in email. In line with GVP VI, Rev 2, publications need not be routinely attached to ICSRs, only if correct interpretation or medical assessment of the case is not possible without the source document.

If the MAH did not attach the article to the ICSR, because it did not consider it necessary or cannot attach articles in case of E2B(R2) XMLs, OGYÉI will contact the MAH, if the article is deemed necessary for further assessment of the case.

Click here for more information on the processing of ICSRs originating from the scientific literature.

5. Testing with OGYÉI and pilot phase

With the launch of simplified reporting, MAHs are no longer be in direct contact with OGYÉI; therefore testing of MAH systems with OGYÉI is not reasonable any longer.

Until simplified reporting will have been initiated for SUSAR reports, direct contact between MAHs and OGYÉI is maintained. Nevertheless, as OGYÉI is an EVWEB client (using the web application of EV as provided and maintained by the EMA), no testing or pilot phase is required from any of its partners. For any further information, please contact the Clinical Trials Division.

6. What to do in case of system failure

In case of failure of reporting systems, guidance of EMA should be followed, which can be accessedhere(EU Individual Case Safety Report (ICSR) Implementation Guide I.C.2.1.6 What to do in case of system failure).

If system failure concerns the reporting of SUSARs, please contact the Clinical Trials Division for any further information.

7. Frequent errors with negative impact on the quality of ICSRs

For more information onfrequent errors identified in MAH reports with negative impact on the quality of ICSRs, please read this document, where possible solutions are also offered.

8. Further information / Contact details

MAHs are requested to prepare any ICSRs to be sent to EVPM in full adherence to EV Business Rules and guidance presented in GVP Module VI.

For any further information on the management of spontaneous reports and reports from non-interventional studies please send your query to farmakovigilancia@nngyk.gov.hu.

9. Information for sponsors of clinical trials on reporting SUSARs to OGYÉI

For SUSARs reported from clinical trials, simplified reporting will not be launched until the application of the 536/2014/EU (Clinical Trial) Regulation (exact date is currently unknown).

Supervision and management of safety-related issues of clinical trials is the responsibility of the Clinical Trials Division. SUSARs originating from the territory of Hungary should be sentviaEV to the message receiver identifier OGYÉI (and EVCTMPROD). Further information on safety-related reporting requirements of sponsors can be obtained athttps://ogyei.gov.hu/adverse_reaction_reporting_arising_from_clinical_trials, or clinical trial staff may be contacted:

Éva Madarász, MD

Clinical Trials Division, National Institute of Pharmacy and Nutrition (OGYÉI)

+36.1.886.9300 / 351

Last updated: 2023.05.30 10:13