GMP,药品,药学,制药,新药,色谱,药品生产,中药,药材,原料药,医药,中间体,药用辅料

欧盟的GMP到底是指南呢,还是法规啊

时间: 2012-05-21 01:24:22 作者: 来源: 字号:
欧盟的GMP到底是指南呢,还是法规啊;

另外,有的资料谈到欧盟的GMP分为2部分,第一部分是制剂,第二部分是api;但是目前找到的欧盟GMP多是一个主体文件带19个附录形式的啊。





是法规,和另外两个欧盟的法律文件一起使用的.




欧盟的文件好像分为9卷,GMP在第四卷,结合两个指令,一个兽药和一个人药;

但是俺只是知道这些,总觉得欧盟GMP属于指南一类,但是看到一些培训资料又归为法规。





欧共体条约(consolidated version of the Treaty establishing the European Community,EC Treaty)第249条(最新版2010/C 83/01第288条)规定了欧盟不同的法令:规章(regulation)、指令(directive)、决议(decisions)和主张(opinion)。原文如下:

“In order to carry out their task and in accordance with the provisions of this Treaty, the European Parliament acting jointly with the Council, the Council and the Commission shall make regulations and issue directives, take decisions, make recommendations or deliver opinions.
为了达成其使命并且符合此条约条款规定,欧洲议会与欧洲理事会共同行动,理事会和委员会将制定规章,发布指令,做出决议,给出建议或传递主张。

A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.
规章具有普适性。它的所有条款都将具有法律约束力并且直接应用于各成员国。

A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of for and methods.
指令中对提及的个成员国规定将要达到的结果将具有法律约束力,但是各国官方将有权选择达到目标的形式和方法。

A decision shall be binding in its entirety upon those to whom it is addressed.
决议的整体都具有法律约束力,但只对其中提到的对象。

Recommendations and opinions shall have no binding force.”
建议和主张无法律约束力。

参考阅读:
欧洲药品市场准入的审批程序- 法律文件种类
The ABC of European Union law - THE EU'S MEANS OF ACTION
Sources of EC Law - Primary Law and Secondary Law
欧盟法律、European Union law
欧盟法规制定情况简介
浅析欧盟法与成员国国内法的关系

EU法规参考阅读.rar(61.34k)




EU GMP方针(EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines)前言:Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. 欧盟药品管理规则第4册包括对(欧盟)委员会指令91/356/EEC(分别被指令2003/94/EC和91/412/EEC修订)发布的人用和兽用药品GMP原则和方针的解释指南。(注意我对rules、guidance、guidelines使用了不同的词翻译,当然你也可以用其它词,见仁见智。)(rules包括regulations、directives、decisions、recommendations and opinions,个人意见)

介绍下有:Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use…… 2003年10月8日,委员会指令2003/94/EC发布了人用药品、人用临床研究药品的GMP原则和方针……

所以,我的意见是EU GMP属于建议,无法律约束力(当然,正如tianye同学说的:“它们反应了一种‘委员会立场’,如申请人,市场许可拥有者等遵守这些条款,则对医药产品的评估,许可和管理有促进作用。”);2003/94/EC是指令,有法律约束力。 至于楼主问题,在搞清楚“指南”和“法规”到底指什么之前,我回答不了。




EU Pharmaceutical Legislation

Useful to know

What is a Directive?

A Directive is a legal instrument which is binding, as to the result to be achieved, upon each Member State to whom it is addressed. However, the national authorities are left the choice of form and methods to achieve their objectives. Directives may be addressed to individual, several or all Member States.

In order to ensure that the objectives laid down in directives become applicable to individual citizens, an act of transposition by national legislators is required, whereby national law is adapted to the objectives laid down in directives. Individual citizens are given rights and bound by the legal act when the directive is incorporated into national law.

Since the Member States are only bound by the objectives laid down in directives, they have some discretion, in transposing them into national law, in taking account of specific national circumstances. Transposition must be effected within the period laid down in a directive. In transposing directives, the Member States must select the national forms which are best suited to ensure the effectiveness of Community law (Article 10 (5) ECT, ‘effet utile'  2    1 2 下一页 尾页
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