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[顺势疗法药物的法律地位。质量要求、注册及许可程序]

[The legal status of homeopathic medicines. Quality requirements, registration and permit procedures].

作者信息

Keller K

机构信息

Institut für Arzneimittel, Berlin.

出版信息

Tierarztl Prax. 1992 Jun;20(3):243-7.

PMID:1496516
Abstract

Homeopathic medicaments which are ready for application have to be approved or registered before they can be made available. This procedure is regulated by the "Arzneimittelgesetz (AMG)", a law regulating licensing and registration of medicaments. The commission in charge of the registration and licensing of homeopathic medicaments is the "Aufbereitungskommission D" of the German "Bundesgesundheitsamt (BGA)", the Board of Public Health. Application forms are dealt with on the basis of controlled and non-controlled clinical studies, application observations, and case studies, as well as specialized literature. The commission is trying to do justice to the particular features of the special field of homeopathy.

摘要

可供使用的顺势疗法药物在上市前必须经过批准或注册。这一程序由《药品法》(AMG)规定,该法律对药品的许可和注册进行规范。负责顺势疗法药物注册和许可的委员会是德国联邦公共卫生局(BGA)的“制剂委员会D”。申请表根据对照和非对照临床研究、应用观察、病例研究以及专业文献进行处理。该委员会试图公正对待顺势疗法这一特殊领域的独特之处。

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