药品作为民事权利客体:概念、属性及与国外做法的比较

IF 0.1 Q4 LAW
Alexander V. Prepyalov
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引用次数: 0

摘要

本文探讨了将有限的民间流通物归类为包括仿制药在内的一系列属性的药品的问题。在通过第一部专门法- 1998年6月22日第86-FZ号联邦法“关于药品”之后,制定了将药品作为法律对象的不同法律部门的法律标准。这解释了本研究的相关性及其在立法倡议和监管实践的进一步发展中的实际适用性。通过对国际药品市场上主要国家——美国、日本和德国的法律进行比较,可以确定俄罗斯立法中药品定义的正确性。从德国立法中提供一定程度的继承,术语医学及其属性在2010年4月12日的联邦法律“药品流通”№61-FZ中定义,并在此使用,总体上表明与上述国家相同的方法。由此可以得出结论,俄罗斯立法不是独立发展的,而是在以前和正在进行的俄罗斯研究以及英美和罗马-日耳曼法系学者的研究背景下发展的。本文讨论了药品流通中的争议问题和具有挑战性的实际问题,即区分药品与相关应用化学物质、生物活性添加剂、医疗器械以及香水和美容产品。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A medicine as an object of civil rights: A concept, attributes and comparison to the foreign approach
The article addresses the issue of classifying a limited civil circulation thing as a medicine that is defined by a set of attributes including generic ones. After the adoption of the first specialized law — Federal law “On Medicines” N 86-FZ dated 22.06.1998 legal standards for different law branches where medicine is a law object have been formulated. This explains the relevance of this research and its practical applicability in further development of legislative initiatives and regulatory practices. The correctness of medicine definition in the Russian legislation can be determined by the comparison of laws of the leading countries on the international pharmaceutical market — USA, Japan and Germany. Providing a certain degree of succession from German legislation, the term medicine and its attributes as they are defined in the Federal law “On Circulation of Medicines” № 61-FZ dated 12.04.2010 and used herein, in general demonstrate the same approach as in the countries mentioned above, which allows to conclude that the Russian legislation has been developing not independently but rather in the context of previous and ongoing studies of Russian researches and scholars from Anglo-American and Romano-Germanic legal systems. The article addresses controversial issues of drug circulation and challenging practical aspects, namely distinguishing medicines from related by application chemical substances, biologically active additives, medical devices and perfume and beauty products.
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来源期刊
CiteScore
0.30
自引率
50.00%
发文量
18
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