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英汉对照法律资源--中华人民共和国药品管理法          【字体:
 

英汉对照法律资源--中华人民共和国药品管理法

作者:无忧教育    文章来源:51education.net    点击数:    更新时间:2008-5-18     


dicines produced, as well as necessary instruments and equipment.

(四)具有保证药品质量的规章制度。

 (4) It shall have rules and regulations to ensure the quality of medicines.

第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的,发给认证证书。

Article 9 Pharmaceutical producing enterprises must organize production in accordance with the "Standards for Quality Control of Pharmaceutical Production" formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the "Standards," and shall issue certificates to those qualified ones.

《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

The detailed implementation measures and implementation process of the "Standards for Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

第十条 除中药饮片的炮制外,药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产,生产记录必须完整准确。药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批准。

Article 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.

中药饮片必须按照国家药品标准炮制;国家药品标准没有规定的,必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。

The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.

第十一条 生产药品所需的原料、辅料,必须符合药用要求。

Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.

第十二条 药品生产企业必须对其生产的药品进行质量检验;不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的,不得出厂。

Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory.

第十三条 经国务院药品监督管理部门或者国务院药品监督管理部门授权的省、自治区、直辖市人民政府药品监督管理部门批准,药品生产企业可以接受委托生产药品。

Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.

 第三章 药品经营企业管理

Chapter III Administration of Pharmaceutical Trading Enterprises

 第十四条 开办药品批发企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品经营许可证》;

Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License.

开办药品零售企业,须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》,凭《药品经营许可证》到工商行政管理部门办理登记注册。无《药品经营许可证》的,不得经营药品。

The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.

《药品经营许可证》应当标明有效期和经营范围,到期重新审查发证。

A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

药品监督管理部门批准开办药品经营企业,除依据本法第十五条规定的条件外,还应当遵循合理布局和方便群众购药的原则。

The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.

第十五条 开办药品经营企业必须具备以下条件:

Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

(一)具有依法经过资格认定的药学技术人员;

 (1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.

(二)具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境;

 (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

(三)具有与所经营药品相适应的质量管理机构或者人员;

 (3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

(四)具有保证所经营药品质量的规章制度。

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