Medicinal Products

HALMED celebrates 40 years of spontaneous adverse reaction reporting in Croatia


The Republic of Croatia celebrates this year forty years of spontaneous suspected adverse reaction reporting. On this occasion that is important for monitoring the safe use of medicines, the Agency for Medicinal Products and Medical Devices (HALMED) has published on its webpages a number of informative texts posted in the occasional section "40 years of spontaneous ADR reporting in Croatia” to make users and patients more familiar with the importance and procedures of suspected adverse reaction reporting as well as with the system of monitoring the safe use of medicines in Croatia.

The practice of suspected adverse reaction reporting in Croatia began long since 1974, not even ten years after the United Kingdom, the cradle of spontaneous adverse reaction reporting in the world.

The long Croatian tradition of monitoring the safe use of medicines has been marked with numerous successes and Croatia has been placed in the recent years among top 20 countries ranked according to the number and quality of reports per million inhabitants, according to the data published by the Uppsala Monitoring Centre (UMC), the collaborative centre of the World’s Health Organisation responsible for administering the world’s adverse reaction database. Thanks to the concerted efforts of HALMED and all healthcare professionals, patients and marketing authorisation holders that regularly report suspected adverse reactions, the Republic of Croatia is, according to the quality and report numbers per million inhabitants, currently at the high 14th place out of 115 countries in the world participating in the World’s Health Organisation’s monitoring programme of the safety of medicines. A higher number of reports is indicator for the quality of reporting system and every further report means a further information on the medicine for users and healthcare professionals, which in the end means a safer use of medicines.

In addition to healthcare professionals and marketing authorisation holders, or pharmaceutical manufacturers, that are legally obliged to report adverse reactions, already from autumn 2009 in the Republic of Croatia, patients and users of medicines may directly report every suspected adverse reaction directly to HALMED. In August 2012, HALMED was the first in the world to start using the on-line application of the Uppsala Monitoring Centre, the collaborative centre of the WHO, that enables patients and users to actively participate in a simplified manner in the monitoring of safe use of medicines. The application is accessible in the For patients/On-line suspected ADR reporting section of the HALMED’s webpages.

The reporting of adverse reactions is of utmost importance as the analysis of collected data contributes to our better understanding of the medicine’s safety profile, thus providing the most efficacious and safest possible prescribing and use of medicines. In this way, Croatian patients are continuously supplied with safe and quality medicines and direct contributions are made to protect the public health and the health of every individual patient who uses the medicine.

Therefore, we invite all patients and users of medicines to visit the HALMED’s webpages and this new section and inform themselves on the safe use of medicines and report to us every suspected adverse reaction.