E2B Implementation Status in the Republic of Croatia
08.04.2010
Under the Croatian law (Medicinal Products Act (Official Gazette No. 71/07), Act on the Amendments to the Medicinal Products Act (Official Gazette No. 45/09), and the Ordinance on Pharmacovigilance (Official Gazette No. 125/09)), reports of adverse drug reactions (ADRs) involving authorised medicinal products in the Republic of Croatia and the medicinal products in clinical trials in the Republic of Croatia, may be transmitted to the Agency for Medicinal Products and Medical Devices (HALMED) electronically.
The Agency's information system is ready to receive ADR reports from the Marketing Authorisation Holders (MAHs) in case of authorised medicinal products or from the Clinical Trial Authorisation (CTA) holders (Sponsors, SPs) by electronic transmission in line with the E2B (R2) standards through the EudraVigilance system.
The system will be used for local purposes and the Individual Case Safety Reports (ICSRs) sent to HALMED will be entered into the local database called EudraVigilance Member State edition (EV MSe) and will not be sent onward to the EudraVigilance base of the European Medicines Agency (EMA) in London.
In this way, HALMED will be receiving all spontaneous serious unexpected adverse reactions and suspected unexpected serious adverse reactions (SUSARs) from the European Union and third countries (adverse reactions from the world) and all adverse reaction reports from the Republic of Croatia (previously Subject 1 and Subject 2 in the paper format) for the medicinal products authorised for marketing in the Republic of Croatia, as well as all spontaneous serious unexpected adverse reactions from the world and SUSARs from the clinical trials in the world and the Republic of Croatia involving medicinal products in clinical trials in the Republic of Croatia (previously Subject 3 and Subject 4).
MAHs and Sponsors are urged to start testing the electronic transmission of ADRs with HALMED - ICSR (E2B) as soon as possible, and after such transmission is successfully tested, to switch from the paper format to electronic reports.
Questions and answers (QA) - on electronic ADR reporting to HALMED are published on HALMED website under Electronic ADR reporting in E2B standard (EudraVigilance) - Questions and Answers.
If you have any additional questions concerning electronic transmission of ICSRs and SUSARs that have not been answered in the QA section, please contact the person responsible for EV MSe, Ms Viola Macolić Šarinić.
