[1992-2020 年欧盟和美国药品交易监管的发展。报告 2.1992-2001 年欧盟药品交易规范性法律基础的发展]。

Q4 Medicine
E A Volskaya
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引用次数: 0

摘要

文章继续探讨了 1992-2020 年欧盟和美国的药品流通监管问题。文章回顾了 1992-2001 年欧洲药品立法的发展历程。这一阶段的特点是通过指令(间接行动法),通过将其纳入国家规范性法律基础而强制实施。2001 年,通过的法律被编入《欧盟药品法典》(第 2001/83 号指令),该法典对药品从生产到药品控制的主要环节进行了规范。该法典的通过为欧盟在药品领域的立法奠定了基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[The development of regulation of pharmaceuticals turn-over in EU and the USA in 1992-2020. Report 2. Development of normative legal base of pharmaceuticals turn-over in EU in 1992-2001].

The article continues to consider problem of regulation of pharmaceuticals turn-over in the EU and the USA in 1992-2020. The history of development of European pharmaceutical legislation in 1992-2001 is considered. This stage is characterized by passing Directives (laws of indirect action) that were obligatory for implementation through their inclusion into national normative legal bases. In 2001 the passed laws were compiled into EU Pharmaceutical Code (Directive 2001/83) that regulates main sections of pharmaceuticals turn-over from their production to pharmaceutical control. The adoption of Code laid the foundation for EU legislation in the field of medications.

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CiteScore
0.40
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