News and Educations

Adverse Drug Reaction Report for 2015


The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) published the Adverse Drug Reaction Report for 2015 on its website. The report is available in the section Pharmacovigilance/Adverse Drug Reaction Reports, or here (in Croatian).

The report was drafted in accordance with the Medicinal Products Act (Official Gazette, No. 76/13 and 90/14) as well as the corresponding Ordinance on Pharmacovigilance (Official Gazette, No. 83/13) based on which HALMED monitors adverse reactions registered in the Republic of Croatia, which are mandatorily reported by healthcare professionals and marketing authorisation holders. HALMED also receives adverse drug reaction reports directly from patients.

In the course of 2015, HALMED received a total number of 3519 suspected adverse drug reaction reports in the Republic of Croatia. Out of this, 81 report was collected from the published literature data on adverse reactions registered in the Republic of Croatia, 179 reports came out of clinical trials or post-marketing non-intervention studies, whereas 3259 reports were collected through spontaneous reporting of adverse reactions by healthcare professionals and patients/medicinal product users, which HALMED received directly or they were forwarded by marketing authorisation holders or the Croatian Institute of Public Health.

The total number of suspected adverse reaction reports increased in 2015 for 13% as compared to 2014, when 3112 reports were received, which speaks to the strengthening of awareness of importance of reporting suspected adverse reactions. In May 2016 HALMED launched a mobile application which enables patients and healthcare professionals to report every suspected adverse reaction in an even more simple and accessible manner. Therefore we expect that the introduction of this new reporting channel will lead to an even greater number of suspected adverse reaction reports in the future.

In order to make the process of reporting and processing of suspected adverse reactions as efficient as possible, HALMED refers reporters to the reporting via the newly introduced mobile application (App Store; Google Play) or via the online application available on HALMED's website.