International Cooperation
European Commission
HALMED collaborates with the European Commission (EC) through the participation of HALMED representatives in the work of EC committees and working groups related to medicinal products and medical devices. Additionally, HALMED participates in several consultative and working processes at the level of national competent authorities of individual EU member states, coordinated by the EC.
Council of the European Union
HALMED, in cooperation with the Permanent Representation of Croatia to the European Union and the Ministry of Health, participates in the adoption of European legislation in the field of medicinal products and medical devices through its work in the committees and working groups of the Council of the European Union.
European Medicines Agency
HALMED collaborates with the European Medicines Agency (EMA) by participating in the work of the Management Board, scientific committees, and EMA working groups related to the approval and safety of human medicinal products on the EU/EAA market.
European Directorate for the Quality of Medicines & HealthCare
HALMED collaborates with the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in the preparation of monographs for the European Pharmacopoeia, as well as in the work of committees and subcommittees of the Council of Europe organized by the EDQM.
Heads of Medicines Agencies
HALMED operates within the framework of the Heads of Medicines Agencies (HMA) network, focusing on the efficiency of the regulatory system for medicinal products in the European market and activities related to both legal and voluntary regulatory actions. HALMED representatives participate in the activities of numerous HMA working groups and projects.
Competent Authorities for Medical Devices
HALMED participates in the work of the Competent Authorities for Medical Devices (CAMD) network, focusing on maintaining joint work among national regulatory bodies, exchanging information, and supervising medical devices on the European market.
World Health Organization
HALMED collaborates with the Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO) in the area of drug safety monitoring. HALMED also participates in the work of the WHO International Pharmacopoeia and in activities related to counterfeit medicinal products. HALMED has designated contact points for collaboration and information exchange regarding counterfeit medicinal products.
Additionally, HALMED actively collaborates with the WHO by providing expert support on behalf of the Republic of Croatia in WHO efforts to build and improve the functioning of national regulatory bodies in member-countries responsible for medicinal products.
Pharmaceutical Inspection Convention/Scheme
As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), HALMED promotes active collaboration among competent inspection bodies in the field of Good Manufacturing Practice (GMP). The goal is international harmonization of GMP standards and guidelines, as well as the education of competent authorities and quality systems in pharmaceutical inspectorates regarding medicinal products.
The Professional Society for Health Economics and Outcomes Research
HALMED collaborates with the Professional Society for Health Economics and Outcomes Research (ISPOR) in the areas of pharmacoeconomics and treatment outcome research.
Competent authorities for medicinal products and medical devices outside the EU
HALMED collaborates with competent authorities for medicinal products and medical devices in non-EU countries. HALMED cooperates with agencies in Southeast Europe based on signed Memorandums of Cooperation and Understanding with the Agency for Medicines and Medical Devices of Serbia (ALIMS), the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBiH), the Bureau of Medicines of the Ministry of Health of the Republic of Macedonia, and the Institute for Medicines and Medical Devices of Montenegro (CInMED). HALMED has bilateral cooperation protocols with CInMED and ALMBiH. Additionally, HALMED works with competent authorities in Southeast Europe on data exchange related to the supply of medicines to the market.
