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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
[Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.
第十三条销售药品必须准确无误，并正确说明用法、用量和注意事项;
属类：法学专业-中国法律-药品管理法
In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation.
调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。
属类：法学专业-中国法律-药品管理法
Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.
对有配伍禁忌或者超剂量的处方应当拒绝调配;必要时经处方医生更正或者重新签字，方可调配。
属类：法学专业-中国法律-药品管理法
Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.
销售地道中药材，必须标明产地。
属类：法学专业-中国法律-药品管理法
[Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.
第十四条药品仓库必须制定和执行药品保管制度，采取必要的冷藏、防潮、防虫、防鼠等措施。
属类：法学专业-中国法律-药品管理法
An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.
药品入库出库必须执行检查制度。
属类：法学专业-中国法律-药品管理法
[Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.
第十五条城乡集市贸易市场可以出售中药材，国家另有规定的除外。
属类：法学专业-中国法律-药品管理法
Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.
城乡集市贸易市场不得出售中药材以外的药品持有《药品经营企业许可证》的除外。
属类：法学专业-中国法律-药品管理法
CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS
第四章医疗单位的药剂管理
属类：法学专业-中国法律-药品管理法
[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.
第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员，非药学技术人员不得直接从事药剂技术工作。
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. |
|
| 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. |
|
| 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. |
|
| 11 | 第十三条销售药品必须准确无误，并正确说明用法、用量和注意事项; | [Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely. |
|
| 12 | 调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。 | In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation. |
|
| 13 | 对有配伍禁忌或者超剂量的处方应当拒绝调配;必要时经处方医生更正或者重新签字，方可调配。 | Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up. |
|
| 14 | 销售地道中药材，必须标明产地。 | Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin. |
|
| 15 | 第十四条药品仓库必须制定和执行药品保管制度，采取必要的冷藏、防潮、防虫、防鼠等措施。 | [Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc. |
|
| 16 | 药品入库出库必须执行检查制度。 | An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse. |
|
| 17 | 第十五条城乡集市贸易市场可以出售中药材，国家另有规定的除外。 | [Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State. |
|
| 18 | 城乡集市贸易市场不得出售中药材以外的药品持有《药品经营企业许可证》的除外。 | Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held. |
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| 19 | 第四章医疗单位的药剂管理 | CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS |
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| 20 | 第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员，非药学技术人员不得直接从事药剂技术工作。 | [Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work. |
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