Comparison of Kosovo pharmaceutical legislation to the requirements of the European Union

Introduction: The importance of the pharmaceutical legislation of a country consists in establishing rules, laws, bylaws and decisions based on which the daily work takes place in health institutions in general and the pharmaceutical sector in particular. The structure of today's pharmaceutical legislation, in terms of drug laws, the scope of drug regulatory agencies, drug evaluation boards, quality control laboratories and drug information centers has evolved over time.Aim: The purpose of this paper is to collect existing information related to the pharmaceutical sector and assess the pharmaceutical profile of Kosovo according to the WHO form. Comparing the pharmaceutical legislation of Kosovo with those of the EU, with the aim of identifying aspects which require harmonize with EU laws and directives, with the laws in force in Kosovo, as well as suggesting options for improvement.Materials and Methods: The pharmaceutical legislation of the European Union, Kosovo, and Austrian have been used as materials. For the comparison of pharmaceutical legislation, we have done the analysis according to four dimensions: administrative elements, regulatory functions, technical elements and level of regulation. We have collected data through a standardized form for regulatory assessment developed by the WHO and through the method of studying the archive. The method of studying the archive has included the evaluation of relevant documentation and records, which includes laws, executive orders, reports of relevant authorities, economic, health and other state indicators, as well as reports of other studies in this field. In the study we used the comparative approach to achieve the comparison of inter-state experiences related to pharmaceutical legislation.Conclusions: Relevant state institutions of Kosovo should be engaged in providing institutional reports related to data on the pharmaceutical sector, in order to institutionally complete the pharmaceutical profile of Kosovo, as required by the WHO.Keywords: Pharmaceutical legislation, European Union, Kosovo, Comparison