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[保障动物健康和消费者保护的药品质量]

[Guarantee of drug quality for animal health and consumer protection].

作者信息

Kroker R

机构信息

Robert von Ostertag Institut, Bundesgesundheitsamt, Berlin.

出版信息

Dtsch Tierarztl Wochenschr. 1994 Jul;101(7):278-80.

PMID:7924965
Abstract

The creation of the single market and the intended free trade of goods, individuals, capital investments and services lead to the question if the quality standards of veterinary drugs are going to be changed in view of an improved animal health and consumer protection. However, the comparison between registration and surveillance criteria that result from the German Law for Medicinal Products and the criteria valid in the European Union as a consequence of Regulations and Directives shows that no changes leading to a reduced quality are to be expected. On the contrary, the application of EU Directives to the respective national law results in a number of improvements, like for example the environmental assessment of veterinary drugs.

摘要

单一市场的建立以及预期的货物、人员、资本投资和服务的自由贸易引发了这样一个问题:鉴于动物健康状况的改善和对消费者的保护,兽药的质量标准是否会发生变化。然而,将德国药品法规定的注册和监管标准与欧盟法规和指令所适用的有效标准进行比较后发现,预计不会出现导致质量降低的变化。相反,将欧盟指令应用于各国法律带来了许多改进,例如兽药的环境评估。

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