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[欧盟与毒品]

[The European Union and drugs].

作者信息

Viala G, Campion M D

机构信息

UFR de Pharmacie, Aix-Marseille II.

出版信息

Ann Pharm Fr. 1995;53(4):184-7.

PMID:7574273
Abstract

1993 is a mythical year for the European Union which symbolizes at once the Achievement of the Internal market and the entry into force of Treaties of Policy and Economic Union. The European Union makes up, in all respects, a New Deal for Medicinal Products. Indeed, the scientific and technical harmonization is realized now at international level (ICH); the broader community competencies in the fields of Research, Industrial Policy and Environment predict a new positive context for innovation industry and competition probably in accordance with the European Agency. A contrario, the recognition of competences of Member States due to subsidiary in the following matters: Public Health, Social Security allow some flexibility in the interests of consumers, differences being explained by social and cultural behaviour in each Member State.

摘要

1993年对欧盟来说是具有传奇色彩的一年,它同时象征着内部市场的建成以及政策与经济联盟条约的生效。从各方面来看,欧盟都构成了药品领域的一项新政。的确,目前在国际层面(国际人用药品注册技术协调会)已经实现了科学技术的协调统一;在研究、产业政策和环境领域更广泛的共同体权限预示着创新产业和竞争将迎来一个新的积极环境,这可能与欧洲药品管理局的情况相符。相反,由于在公共卫生、社会保障等以下事项上成员国的权限基于辅助性原则而得到承认,这使得在消费者利益方面存在一定灵活性,而这些差异是由每个成员国的社会和文化行为所解释的。

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