【文章內(nèi)容簡介】 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. 第十五條 開辦藥品經(jīng)營企業(yè)必須具備以下條件： Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met （一）具有依法經(jīng)過 資格認定的藥學技術(shù)人員； (1) 1 It shall be staffed with legally certified pharmaceutical technical personnel. （二）具有與所經(jīng)營藥品相適應的營業(yè)場所、設備、倉儲設施、衛(wèi)生環(huán)境； (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades. 8 （三）具有與所經(jīng)營藥品相適應的質(zhì)量管理機構(gòu)或者人員； (3) It shall have a quality control an or personnel suitable for the pharmaceuticals in which it trades. （四）具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades. 第十六條 藥品經(jīng)營企業(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營質(zhì)量管理規(guī)范》經(jīng)營藥品。藥品監(jiān)督管理部門按照規(guī)定對藥品經(jīng)營企業(yè)是否符合《藥品經(jīng)營質(zhì)量管理規(guī)范》的要求進行認證；對認證合格的，發(fā)給認證證書。 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. 《藥品經(jīng)營質(zhì)量管理規(guī)范》的具體實施辦法、實施步驟由國務院藥品監(jiān)督 管理部門規(guī)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. 第十七條 藥品經(jīng)營企業(yè)購進藥品，必須建 立并執(zhí)行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規(guī)定要求的，不得購進。 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. 第十八條 藥品經(jīng)營企業(yè)購銷藥品，必須有真實完整的購銷記錄。購銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號、有效期、生產(chǎn)廠商、購（銷）貨單位、購（銷）貨數(shù)量、購銷價格、購（銷）貨日期及國務院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。藥品管理法（ 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. 第十九條 藥品經(jīng)營企業(yè)銷售藥品必須準確無誤，并正確說明用法、用量和注意事項； 調(diào)配處方必須經(jīng)過核對，對處方所列藥品不得擅自更改或者代用。對有配伍禁忌或者超劑量的處方，應當拒絕調(diào)配；必要時，經(jīng)處 方醫(yī)師更正或者重新簽字，方可調(diào)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. 藥品經(jīng)營企業(yè)銷售中藥材，必須標明產(chǎn)地。 When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated. 第二十條 藥品經(jīng)營企業(yè)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)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. 藥品入庫和出庫必須執(zhí)行檢查制度。 An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse 第二十一條 城鄉(xiāng)集市貿(mào)易市場可以出售中藥材，國務院另有規(guī)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 城鄉(xiāng)集市貿(mào)易市場不得出售中藥材以外的藥品，但持有《藥品經(jīng)營許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設 點出售中藥材以外的藥品。具體辦法由國務院規(guī)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 醫(yī)療機構(gòu)的藥劑管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第二十二條 醫(yī)療機構(gòu)必須配備依法經(jīng)過資格認定的藥學技術(shù)人員。非藥學技術(shù)人員不得直接從事藥劑技術(shù)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. 第二十三條 醫(yī)療機構(gòu)配制制劑，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準，發(fā)給《醫(yī)療機構(gòu)制劑許可證》。無《醫(yī)療機構(gòu)制劑許可證》的，不得配制制劑。 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