药品自由流通和公共卫生保护。

Federico Forni
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引用次数: 0

摘要

在Pharma Expressz的判决(C-178/20号案件)中,法院澄清了成员国可以对在国家领土上没有上市许可的药品进口施加哪些条件。法院指出,未经成员国授权的药物只能根据2001/83/EC号指令关于人类使用的药品的第5(1)条进入该成员国。此外,法院认为,尽管该产品可以在没有处方的情况下在另一个成员国分发,但要求国家卫生主管部门开具处方和声明的国家措施是保护公众健康的正当理由。在概述了欧盟制药法的发展之后,本文分析了这一判决,法院在该判决中平衡了《条约》关于货物自由流动的规则与保护人类健康的必要性。
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Free Movement of Medicines and Protection of Public Health.
In the Pharma Expressz judgment (case C-178/20) the Court of Justice clarified which conditions a Member State can impose to the import of a medicinal product not having a marketing authorisation in the national territory. The Court pointed out that a medicine not authorised in a Member State can entry in that Member State only in accordance with Article 5(1) of Directive 2001/83/EC on medicinal products for human use. Moreover, according to the Court a national measure requiring a medical prescription and a declaration from the competent national health authority is justified to protect public health although the product can be dispensed in another Member State without a medical prescription. After an overview on the development of pharmaceutical law in the EU, the contribution analyses this judgment in which the Court balanced the Treaty rules on the free movement of goods with the need to protect human health.
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来源期刊
CiteScore
0.90
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0.00%
发文量
52
期刊介绍: The European Journal of Jewish Studies (EJJS) is the Journal of the European Association for Jewish Studies (EAJS). Its main purpose is to publish high-quality research articles, essays and shorter contributions on all aspects of Jewish Studies. Submissions are all double blind peer-reviewed. Additionally, EJJS seeks to inform its readers on current developments in Jewish Studies: it carries comprehensive review-essays on specific topics, trends and debated questions, as well as regular book-reviews. A further section carries reports on conferences, symposia, and descriptions of research projects in every area of Jewish Studies.
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