Medicinal Products

Requirements for ICSR Reports after the Croatian Accession to the EU

The European Medicines Agency (EMA) announced on its website a refreshed list of requests for the approval of the holders of authorisations related to filing Individual Case Safety Reports (ICSR) in a transition period, with the name "Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period". The new version of the document includes requirements for filing ICSRs in Croatia during the transition period until the full functionality of the EudraVigilance system has been established, which will be introduced from the date of the accession of the Republic of Croatia to the European Union. This document is available on the part of the EMA website devoted to questions and answers about the implementation of pharmacovigilance legislation, which is here.

After the Croatian accession to the EU, the marketing authorization holders will not be affected by changes related to the requirements on reporting adverse reactions to HALMED apart from the deadline for the registration of non-serious adverse effects, which must be submitted within 90 days of discovery. Starting from July 1, 2013, authorization holders will report adverse reactions from third-countries exclusively to the European Medicines Agency.