Romanian Society of Pharmaceutical Sciences

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INVOLVING PHARMACIES IN PHARMACOVIGILANCE – A COMPARISON BETWEEN FRANCE AND ROMANIA

ALEXANDRA TOMA *, OFELIA CRIŞAN

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 considerable interest in monitoring the safety of medicines prompted for a change of the European pharmacovigilance legislation, setting specific attributions for the marketing authorization holders and the competent authorities for human medicines. However, each Member State has remained responsible for organising its own pharmacovigilance system. Consequently, the degree of involvement of other entities of the health care system, such as pharmacies, in the national pharmacovigilance system, will differ among countries. The aim of this study was to compare the pharmacovigilance legislation of France and Romania, in order to identify the best practices for involving pharmacies in pharmacovigilance. The normative texts found by legal documentary research were analysed using the comparative method and methods of legal interpretation. In France, the pharmacovigilance system is decentralised, being organised both at national and regional levels, and coordinated by the national competent authority, which established a set of specific good practices for all the entities involved in pharmacovigilance, including pharmacists working in pharmacies. In Romania, the pharmacovigilance system is centralised, organised only at the national level, and coordinated by the national competent authority, which has made considerable efforts to develop it in our country. To make progress in that way, it is necessary to set up local pharmacovigilance centres, in collaboration with universities and hospitals. To better involve pharmacies in pharmacovigilance, the development and implementation of specific rules of good pharmacy practice are needed.