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[欧洲药典的作用与功能]

[Role and functions of the European Pharmacopoeia].

作者信息

Stainier C

出版信息

Ann Ist Super Sanita. 1975;11(3-4):211-9.

PMID:1234723
Abstract

Following an agreement between the Common Market on one side and the Partial Agreement of the Council of Europe on the other, it was decided in Rome in April 1963 to compile gradually a Pharmacopeia to be called "European", which would be mandatory in Germany, Belgium, France, Italy, Luxembourg, the Netherlands and the United Kingdom. Switzerland joined the group in 1964. A Commission entrusted with full powers was created: each country is represented on it by a three-member delegation. It started its work in 1964, with prof. Marini-Bettolo as president. The work of the Commission was planned by approximately 150 experts, subdivided into about 15 groups of specialists in the various fields. The first volume was published in 1969, the second in 1971, followed by a supplement in 1973; the third volume was supposed to appear in April 1975 with another supplement planned for the end of 1975. The collection of these volumes will represent the first edition of the European Pharmacopeia and will consist of about 1,500 pages; half of these will cover general rules and the rest will include about 320 monographs. With the addition of Denmark and Ireland, which joined the Common Market at a later date, the European Pharmacopeia will be in force in an area with a population of 260 million. Any country belonging to the Council of Europe is entitled to join the Convention and several countries have already expressed the desire to do so.

摘要

根据一方的共同市场与另一方的欧洲理事会部分协议达成的一项协议,1963年4月在罗马决定逐步编纂一部名为《欧洲药典》的药典,该药典在德国、比利时、法国、意大利、卢森堡、荷兰和英国具有强制性。瑞士于1964年加入该组织。设立了一个拥有全权的委员会:每个国家由一个三人代表团代表参加。该委员会于1964年开始工作,由马里尼 - 贝托洛教授担任主席。委员会的工作由大约150名专家规划,这些专家细分为约15个不同领域的专家小组。第一卷于1969年出版;第二卷于1971年出版,随后在1973年出版了一份增补本;第三卷原定于1975年4月出版,另一份增补本计划于1975年底出版。这些卷册的合集将代表《欧洲药典》的第一版,约有1500页;其中一半将涵盖通用规则,其余部分将包括约320个专论。随着后来加入共同市场的丹麦和爱尔兰的加入,《欧洲药典》将在一个拥有2.6亿人口的地区生效。任何属于欧洲理事会的国家都有权加入该公约,并且已有几个国家表示希望这样做。

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