Pharmacovigilance

Information on Authorisation Holders' ADR reporting obligation

Important notice to Marketing Authorisation Holders and Clinical Trial Authorisation Holders in the Republic of Croatia on suspension of submitting SUSARs from the third countries to HALMED

Marketing Authorisation Holders (MAHs) and Clinical Trial Authorisation Holders (CTAHs) in the Republic of Croatia are herewith informed that starting from 1 June 2013 the Agency for Medicinal Products and Medical Devices (HALMED) will cease to receive SUSARs from the third countries (EU and non-EU countries) involving medicinal products authorised for marketing in the Republic of Croatia or medicinal products in clinical trials in the Republic of Croatia seeing HALMED now has a direct access to EudraVigilance database of the European Medicines Agency (EMA), which makes all of these applications visible to the Croatian regulatory body for medicinal products, as well.

Following the above, starting from 1 June 2013 Authorisation Holders must cease to submit SUSARs from the third countries to HALMED both electronically and in paper format.

Until 30 June 2013 Marketing Authorisation Holders must continue submitting to HALMED Individual Case Safety Reports (ICSRs) which have been created and submitted from the territory of the Republic of Croatia regardless of the seriousness of the suspected adverse reaction report (serious and non-serious) within 15 days from the date of receipt of the report. Starting from 1 July 2013 serious adverse reactions from the territory of the Republic of Croatia should be submitted to HALMED exclusively electronically within 15 days from the date of receipt of the report, while non-serious adverse reactions should be submitted within 90 days from the date of receipt of the report. Adverse reactions submitted by Authorisation Holders and directly from healthcare workers in ICSR form will be sent by HALMED to EudraVigilance database of the European Medicines Agency (EMA). This way of submitting will continue until the complete establishment of the electronic system of direct submitting adverse reactions to EMA using EudraVigilance system, which should occur in 2015 at the earliest.

Clinical Trial Authorisation Holders should continue to electronically submit SUSARs from the clinical trials in the Republic of Croatia within 15 days (7 days respectively) from the date of receipt of the report. These reports stay in the national adverse reactions database and are not sent to EMA, whereas the Clinical Trial Authorisation Holder is obliged to submit them electronically to EudraVigilance CT module.