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保加利亚和北马其顿社区药房的立法与监管框架分析

Analysis of Legislative and Regulatory Frameworks Governing Community Pharmacy in Bulgaria and North Macedonia.

作者信息

Todorova Anna, Ivanova Mariya, Pesheva Magdalena, Miceva Dijana, Angelovska Bistra

机构信息

Faculty of Pharmacy, Medical University of Varna, 9000 Varna, Bulgaria.

Faculty of Medical Sciences, Goce Delcev University, Krste Misirkov Str., No. 10-A, P.O. Box 201, 2000 Stip, North Macedonia.

出版信息

Pharmacy (Basel). 2025 Aug 8;13(4):108. doi: 10.3390/pharmacy13040108.

Abstract

The common border between Bulgaria and North Macedonia, alongside the regulatory requirements stemming from Bulgaria's membership in the European Union, provide grounds for comparing the legislative environment in both countries. This article presents a comparative case study of the regulatory frameworks governing community pharmacies in Bulgaria and North Macedonia. The aim of this study is to examine the specific features of current legislation related to the operation of community pharmacies, and to identify similarities, differences, and gaps in the organizational structure of pharmacy services, the population's access to pharmaceutical care, and the qualification requirements for personnel working in community pharmacies. Bulgaria has been a member of the European Union since 2007, while the Republic of North Macedonia has had official EU candidate status since 2005. This provides a basis for comparing the regulatory frameworks of an EU and a non-EU system within the same regional context. In both countries, the overall pharmacy-to-population ratio exceeds the European average (3.3 pharmacies per 10,000 inhabitants), indicating sufficient availability. However, pharmacies are predominantly concentrated in major urban areas. In Bulgaria, challenges remain in ensuring access to pharmaceutical services in smaller and rural settlements, while in North Macedonia, the provision of such services is better ensured. The findings of this case study may be particularly relevant for countries undergoing health system reforms or EU harmonization processes.

摘要

保加利亚与北马其顿的共同边界,以及保加利亚加入欧盟所带来的监管要求,为比较两国的立法环境提供了依据。本文对保加利亚和北马其顿社区药房的监管框架进行了比较案例研究。本研究的目的是考察现行立法中与社区药房运营相关的具体特征,并确定药房服务组织结构、民众获得药学服务的机会以及社区药房工作人员资质要求方面的异同和差距。保加利亚自2007年起成为欧盟成员国,而北马其顿共和国自2005年起拥有欧盟候选国的正式地位。这为在同一区域背景下比较欧盟体系和非欧盟体系的监管框架提供了基础。在两国,药房与人口的总体比例均超过欧洲平均水平(每万名居民有3.3家药房),表明供应充足。然而,药房主要集中在主要城市地区。在保加利亚,在确保较小规模定居点和农村地区获得药学服务方面仍存在挑战,而在北马其顿,此类服务的提供得到了更好的保障。本案例研究的结果可能对正在进行卫生系统改革或欧盟协调进程的国家尤为相关。

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