药品管理法中英文对照

药品管理法中英文对照内容摘要：

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. 8 （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 an 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。 (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。 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。 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. 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。 药品管理法（ 3） Article 18 Pharmaceutical trading enterprises shall keep accurate and plete 9 records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product39。 39。 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 inpatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or resigned 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. 10 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. 第四章 医疗机构的药剂管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第二十二条 医疗机构必须配备依法经过资格认定的药学技术人员。 非药学技术人员不得直接从事药剂技术工作。 Article 22 Medical anizations must be staffed with legally certified pharmaceutical technical personnel. Nonpharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy. 第二十三条 医疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意，由省、自治区、直辖市人民政府药品监督管理部门批准，发给《医疗机构制剂许可证》。 无《医疗机构制剂许可证》的，不得配制制剂。 Article 23 To make medicinal preparations, a medical anization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the anization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments o。