Romanian Society of Pharmaceutical Sciences

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RECENT DEVELOPMENTS IN ROMANIAN LEGISLATION THAT IMPACT THE PHARMACIST’S ACTIVITY

OFELIA CRIŞAN, ALEXANDRA TOMA *

Department of Pharmaceutical Legislation and Management, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 12 Ion Creangă Street, 400010, Cluj-Napoca, Romania

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The objective of this study was to investigate recent developments in national legislation in order to analyse their adequacy to the practice requirements and their consequences on the pharmacist’s activity. As materials, we used texts of normative acts in the last three years which have modified the legislation with an impact on the pharmacist’s activity in Romania, and as methods, documentary research and a pluralist method of legal interpretation. In the last three years, amendments to the legislation on practicing as a pharmacist, collecting waste medicines from the population and carrying out activities related to food supplements have been adopted. The activities that can be pursued by pharmacists have been supplemented with quality assurance of medicines and clinical research, excluding non-clinical research. The collection of waste medicines from the population has been established as a task for hospitals, without providing solutions to rural areas without hospitals. The new legislation on food supplements does not bring anything new in terms of guaranteeing the quality and safety of these products on the market. Romanian legislation requires the inclusion of appropriate provisions regarding pharmacist competence, waste medicine collection in rural areas, and food supplement quality and safety, in the interest of patients and public health.