Post-Authorization Pharmacovigilance Reporting Requirements in Hungary
Legal background
In order to facilitate the exchange of information on pharmacovigilance in the Community, and in accordance with current pharmacovigilance legislation as laid down in Reg. (EC) 726/2004, Dir. 2001/83/EC, and Dir. 2001/20/EC, as amended, marketing authorization holders shall submit all suspected serious adverse reactions reported spontaneously by healthcare professionals or originating from a non-interventional study to the National Competent Authorities and/or the European Medicines Agency via Eudravigilance, the data processing network and management system of the European Economic Area (EEA).
This document is to outline the obligations regarding electronic reporting imposed on the Marketing Authorisation Holder (MAH) as laid down in Hungarian law (as listed hereunder) in accordance with the European legislation. The document also contains guidance on submission of other safety-related information emerging during the post-authorization period.
· Act XCV of 2005 on medicinal products for human use and on the amendment of other laws regulating the pharmaceutical market
· Decree 35/2005 of the Minister of Health on the conduct of clinical trials on investigational medicinal products for human use and the implementation of Good Clinical Practice reviewed on 21/10/2009
· Decree 52/2005 of the Minister of Health on the marketing authorization of medicinal products for human use
Electronic reporting of spontaneous individual case safety reports (ICSRs) and reports from non-interventional studies
MAHs are requested to transmit all serious spontaneous ICSRs and reports from post-marketing non-interventional studies that occurred in the territory of Hungary to National Institute of Pharmacy (NIP) via Eudravigilance with the message receiver identifier OGYIP in accordance with the requirements of expedited reporting observing the 15-day timeline.
NIP does not request direct notification of cases that occurred in the territory of the EEA but outside Hungary or in non-EEA countries, not even if Hungary is the reference member state or rapporteur/co-rapporteur for the product concerned. Non-domestic EEA cases should be transmitted to the National Competent Authority of the country of occurrence, whereas reports of serious adverse reactions originating from a non-EEA country should be submitted directly to the Post-Authorization Module of Eudravigilance with the message receiver identifier EVHUMAN. In both cases, NIP has access to Eudravigilance data and can extract the reports from there for further analysis, if necessary.
All literature cases transmitted to OGYIP should be accompanied by the submission of a reprint of the corresponding article to NIP via e-mail (adr.box@ogyi.hu).
Testing and pilot phase
NIP does not request any of its partners to perform testing or complete a pilot phase.
In case of submitting reports to the Post-Authorization Module, an e-mail notification is required simultaneously when a MAH is submitting to NIP for the first time. The report should be submitted via Eudravigilance in production environment to OGYIP. The receipt of the report will be acknowledged either via Eudravigilance or via an e-mail. Should an error occur in transmission, the sender will be notified in e-mail to inform him/her that the report has not arrived.
What to do in case of system failure
If you are unable to generate an ICH M2 safety messages from a spontaneous report or a report originating from a non-interventional study, or transmit it to OGYIP, switch to alternative means of reporting (e.g. reporting via fax: +36.1.886.9472 or e-mail: adr.box@ogyi.hu), and notify NIP that there is a failure at the sender's site. The receipt of these reports will be acknowledged. If the problem resolved and electronic reporting is resumed, NIP should be informed and the electronic version of the report should be submitted to OGYIP.
Further information / Contact details
National Institute of Pharmacy is an EVWEB client, using exactly the same business rules as the European Medicines Agency.
Contact person for spontaneous reports and reports from non-interventional studies (reports submitted to OGYIP):
Klara Wusinczky, DMD
Pharmacovigilance Department, National Institute of Pharmacy
+36.1.886.9300 / 146
Submission of other post-authorization safety information to NIP
In order to enable timely assessment, pharmacovigilance-related documents (e.g. periodic safety update reports, risk management plans, direct healthcare professional communications and educational materials) should be submitted to NIP via e-mail to adr.box@ogyi.hu for evaluation and approval. If documentation is submitted as a CD-ROM (due to the size of the documentation), a notification of the submission is still required to be sent to adr.box@ogyi.hu. Please refrain from submitting paper-based documentation. Please indicate the following subject identifiers on each submission, respectively:
Periodic safety update reports (PSURs) – 4103
Educational materials – 4107
Direct Healthcare Professional Communications (DHPCs) – 4108
Information for sponsors of clinical trials:
Supervision and management of safety-related issues of clinical trials has been moved to the Clinical Trials Unit of NIP beginning from the 1st October 2011. SUSARs originating from the territory of Hungary should be sent via Eudravigilance to the ID OGYI. Further information on safety-related reporting requirements of sponsors can be obtained at the website of NIP: http://www.ogyi.hu/reporting_requirements/,or Ágnes Hajdú may be contacted:
Agnes Hajdu, MD
Clinical Trials Unit, National Institute of Pharmacy
+36.1.886.9300 / 175
This communication supersedes all previous documents on the electronic reporting requirements of serious adverse reactions in Hungary, and submission of any other safety-related information, and it is valid from 1stJanuary 2012.
