【正文】 o 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(wù)院藥品監(jiān)督 管理部門規(guī)定。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。 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。 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(shè) 點出售中藥材以外的藥品。 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》。 11 Article 24 Medical anizations that make medicinal preparations must have facilities, a managerial system, inspection instruments, and a sanitary environment to ensure quality. 第二十五條 醫(yī)療機構(gòu)配制的制劑，應(yīng)當是本單位臨床需要而市場上沒有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準后方可配制。 Medicinal preparations made by medical anizations may not be sold on the market. 第二十六條 醫(yī)療機構(gòu)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，不得購進和使用。 Article 28 Rules for storage of pharmaceuticals shall be formulated and implemented by medical anizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals. 第五章 藥品管理 Chapter V Pharmaceutical Administration 第二十九條 研制新藥，必須按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質(zhì)量指標、藥理及毒理試驗結(jié)果等有關(guān)資料和樣品，經(jīng)國務(wù)院藥品監(jiān)督管理部門批準后，方可進行臨床試驗。 13 Article 30 The pharmaceutical nonclinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical nonclinical research and the quality control standard for pharmaceutical clinical test. 藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)范由國務(wù) 院確定的部門制定。 Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval. 第三十二條 藥品必須符合國家藥品標準。39。 Article 33 The pharmaceutical supervisory and administrative department under the State Council may anize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production. 第三十四條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進藥品；但是，購進沒有實施批準文號管理的中藥材除外。具體辦法由國務(wù)院制定。 Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people39。 Medicines to be imported in small quantities for urgent clinical needs by medical anizations or for personal use shall go through import formalities according to relevant regulations of the State. 第四十條 藥品必須從允許藥品進口的口岸進口，并由進口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。 16 The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law. 允許藥品進口的口岸由國務(wù)院藥品監(jiān)督管理部門會同海關(guān)總署提出，報國務(wù)院批準。 The inspection fee and charge standards for the abovementioned pharmaceuticals shall be jointly checked, ratified and promulgated by th。 (3) Other pharmaceuticals prescribed by the State Council. 前款所列藥品的檢驗費項目和收費標準由國務(wù)院財政部門會同國務(wù)院價格主管部門核定并公告。無《進口藥品通關(guān)單》的，海關(guān)不得放行。s health shall be prohibited. 第三十九條 藥品進口，須經(jīng)國務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認符合質(zhì)量標準、安全有效的，方可批準進口，并發(fā)給進口藥品注冊證書。具體辦法由國務(wù)院制定。管理辦法由國務(wù)院制定。 The Pharmacopoeia Committee anized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards. 國務(wù)院藥品監(jiān)督管理部門的藥品檢驗機構(gòu)負責(zé)標定國家藥品標準品、對照品。 Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in readytouse forms. 國務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國藥典》和藥品標準為國家藥品標準。實施批準文號管理的中藥材、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理部門會同國務(wù)院中醫(yī)藥管理部門制定。 Article 29 When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council. 完成臨床試驗并通過審批的新藥，由國務(wù)院藥品監(jiān)督管理部門批準，發(fā)給新藥證書。對有配伍禁忌或者超劑量的處方，應(yīng)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。特殊情況下，經(jīng)國務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門批準，醫(yī)療機構(gòu)配制的制劑可以在指定的醫(yī)療機構(gòu)之間調(diào)劑使用。 Article 23 To make medicinal preparations, a medical anization must be examined and approved by the administrative departments of healt