【正文】 der the State Council, and the record of production must be plete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities. 中藥飲片必須按照國家藥品標(biāo)準炮制；國家藥品標(biāo)準沒有規(guī)定的，必須按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范炮制。 The process for preparing traditional Chinese medicines into readytouse forms 6 must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council. 第十一條 生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。 Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce。 Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council. 第三章 藥品經(jīng)營企業(yè)管理 Chapter III Administration of Pharmaceutical Trading Enterprises 第十四條 開辦藥品批發(fā)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管 7 理部門批準并發(fā)給《藥品經(jīng)營許可證》；開辦藥品零售企業(yè)，須經(jīng)企業(yè)所在 地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)給《藥品經(jīng)營許可證》，憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊。 Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the petent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License. The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and merce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals. 《藥品經(jīng)營許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營范圍，到期重新審查發(fā)證。 The approval of 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(xué)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(yīng)的營業(yè)場所、設(shè)備、倉儲設(shè)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(yīng)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。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。 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(biāo)識；不符合規(guī)定要求的，不得購進。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(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。39。對有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)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。 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。 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(wù)院另有規(guī)定的除外。具體辦法由國務(wù)院規(guī)定。非藥學(xué)技術(shù)人員不得直接從事藥劑技術(shù)工作。無《醫(yī)療機構(gòu)制劑許可證》的，不得配制制劑。 The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 第二十四條 醫(yī)療機構(gòu)配制制劑，必須具有能夠保證制劑質(zhì)量的設(shè)施、管理制度、檢驗儀器和衛(wèi)生條件。配制的制劑必須按照規(guī)定進行質(zhì)量檢驗；合格的，憑醫(yī)師處方在本醫(yī)療機構(gòu)使用。 Article 25 The medicinal preparations made by medical anizations shall be of the kinds that supply the clinical needs of the units themselves but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located. The quality of the medicinal preparations made by medical anizations must be inspected in accordance with relevant regulations. Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with approval from the pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities directly under the central government, the medicinal preparations made by medical anizations can be shared among appointed medical anizations. 醫(yī)療機構(gòu)配制的制劑，不得在市場銷售。 Article 26 When purchasing pharmaceuticals, medical anizations must formulate an