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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     


 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.

第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。

Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the "Standards for Quality Control of Pharmaceutical Trading" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law.

药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证;对认证合格的,发给认证证书。

Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the "Standards for Quality Control of Pharmaceutical Trading" in accordance with relevant regulations, and issue certifications to qualified enterprises.

《药品经营质量管理规范》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。

Detailed implementation measures and procedures for the "Standards for Quality Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.

第十七条 药品经营企业购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进。

Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.

第十八条 药品经营企业购销药品,必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购(销)货单位、购(销)货数量、购销价格、购(销)货日期及国务院药品监督管理部门规定的其他内容。

Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.

第十九条 药品经营企业销售药品必须准确无误,并正确说明用法、用量和注意事项;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。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.

药品经营企业销售中药材,必须标明产地。

When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十条 药品经营企业必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality.

药品入库和出库必须执行检查制度。

An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse

第二十一条 城乡集市贸易市场可以出售中药材,国务院另有规定的除外。

Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

城乡集市贸易市场不得出售中药材以外的药品,但持有《药品经营许可证》的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以外的药品。具体办法由国务院规定。

Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.

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