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中国法律:药品管理法:
[Article 8] Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory.
第八条药品出厂前必须经过质量检验;不符合标准的,不得出厂。
属类：法学专业-中国法律-药品管理法
[Article 9] Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health.
第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求,制定和执行保证药品质量的规章制度和卫生要求。
属类：法学专业-中国法律-药品管理法
CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES
第三章药品经营企业的管理
属类：法学专业-中国法律-药品管理法
[Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence".
第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意,经县级以上卫生行政部门审核批准,并发给《药品经营企业许可证》。无《药品经营企业许可证》的,工商行政管理部门不得发给《营业执照》。
属类：法学专业-中国法律-药品管理法
A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health.
《药品经营企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。
属类：法学专业-中国法律-药品管理法
[Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:
第十一条开办药品经营企业必须具备以下条件:
属类：法学专业-中国法律-药品管理法
(1)It must employ pharmaceutical technicians appropriate to the medicines handled.
(一)具有与所经营药品相适应的药学技术人员。
属类：法学专业-中国法律-药品管理法
Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.
经营中药的企业和兼营药品的企业没有药学技术人员 . 配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。
属类：法学专业-中国法律-药品管理法
(2)It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.
(二)具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。
属类：法学专业-中国法律-药品管理法
[Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.
第十二条收购药品,必须进行质量验收;不合格的,不得收购。
属类：法学专业-中国法律-药品管理法
| 1 | 第八条药品出厂前必须经过质量检验;不符合标准的,不得出厂。 | [Article 8] Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory. |
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| 2 | 第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求,制定和执行保证药品质量的规章制度和卫生要求。 | [Article 9] Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health. |
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| 3 | 第三章药品经营企业的管理 | CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES |
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| 4 | 第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意,经县级以上卫生行政部门审核批准,并发给《药品经营企业许可证》。无《药品经营企业许可证》的,工商行政管理部门不得发给《营业执照》。 | [Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence". |
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| 5 | 《药品经营企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。 | A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health. |
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| 6 | 第十一条开办药品经营企业必须具备以下条件: | [Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions: |
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| 7 | (一)具有与所经营药品相适应的药学技术人员。 | (1)It must employ pharmaceutical technicians appropriate to the medicines handled. |
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| 8 | 经营中药的企业和兼营药品的企业没有药学技术人员 . 配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。 | Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level. |
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| 9 | (二)具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。 | (2)It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled. |
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| 10 | 第十二条收购药品,必须进行质量验收;不合格的,不得收购。 | [Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased. |
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