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[兽药的欧洲注册]

[European registration of veterinary drugs].

作者信息

Reijnders P J

机构信息

Janssen Pharmaceutica B.V. Tilburg.

出版信息

Tijdschr Diergeneeskd. 1993 Apr 15;118(8):271-4.

PMID:8484182
Abstract

An overview is given for the harmonization of veterinary medicines in the EC. What is the influence of the review caused by this process on the existing veterinary medicines? Besides the role of the Committee of Veterinary Medicinal Products (CVMP) in the registration process of mutual recognition and central registration, the role of its working parties are dealt with. Also the consequences of the recent residue legislation on the basis of Maximum Residue Levels (MRL's) are discussed for as well the existing as the new products. Recently adverse events have to be reported too and evaluated by the authorities. Are all the member states ready for this task? The tasks and procedures of the future European Agency for the Evaluation of Medicines and the future registration procedures are also discussed.

摘要

本文概述了欧盟兽药的协调情况。这一过程引发的审查对现有兽药有何影响?除了兽药产品委员会(CVMP)在相互认可和集中注册过程中的作用外,还探讨了其工作小组的作用。此外,还讨论了基于最高残留限量(MRL)的最新残留法规对现有产品和新产品的影响。最近,不良事件也必须上报并由当局进行评估。所有成员国都准备好承担这项任务了吗?还讨论了未来欧洲药品评估局的任务和程序以及未来的注册程序。

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