Continuous safety monitoring of investigational medicinal products used in clinical trials
Under the Medicinal Products Act and the current HALMED's price list approved by the Minister of Health, HALMED collects fees for continuous safety monitoring of investigational medicinal products used in clinical trials in the Republic of Croatia.
The following is charged once a year, in the month of the clinical trial application approval date, for all clinical trials approved in Croatia. Such approach allows financing of the legislation-defined activities of HALMED not covered by the prices of individual HALMED services in the field of investigational medicinal products, which include the following:
- receipt, processing and scientific evaluation of suspected unexpected serious adverse reactions (SUSAR-s) occurring in clinical trials in Croatia
- processing of the annual safety reports (ASR-s)
- reporting of the received safety information from clinical trials towards Central Ethics Committee and Ministry of Health
- maintenance of the IT system necessary for monitoring safety of medicinal products in clinical trials in Croatia:
- the national database on adverse reactions
- local maintenance of the EudraVigilance Gateway (the link to the European database of all adverse reactions)
- maintenance of the system towards the World Health Organization (WHO) adverse reaction database
- activities of HALMED’s representatives in European bodies competent for coordination and oversight of clinical trials
- the work of HALMED’s Medicinal Products’ Safety Committee.
- detection of safety signals from SUSAR-s on the European Union level when Croatia is a safety assessing member state (saMS)
