【正文】 檢驗費收繳辦法由國務院財政部門會同國務院藥品監(jiān)督管理部門制定。 Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs. 口岸所在地藥品監(jiān)督管理部門應當通知藥品檢驗機構按照國務院藥品監(jiān)督管理部門的規(guī)定對進口藥品進行抽查檢驗，并依照本法第四十一條第 二款的規(guī)定收取檢驗費。 Article 39 The import of medicines must go through examinations anized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import. 醫(yī)療單位臨床急需或者個人自用進口的少量藥品，按照國家有關規(guī)定辦理進口手續(xù)。 Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and nonprescription pharmaceuticals. 第三十八條 禁止進口療效不確、不良反應大或者其他原因危害人體健康的藥品。 Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control. 第三十六條 國家實行中藥品種 保護制度。 The pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals. 第三十三條 國務院藥品監(jiān)督管理部門組織藥學、醫(yī)學和其他技術人員，對新藥進行審評，對已經(jīng)批準生產(chǎn)的藥品進行再評價。 14 The Pharmacopoeia of the People39。 Article 31 A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative department under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in readytouse forms that are not controlled under a registered document of approval. For those traditional Chinese medicinal herbs and traditional Chinese medicines prepared in readytouse forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall jointly formulate their type catalogue. 藥品生產(chǎn)企業(yè)在取得藥品批準文號后，方可生產(chǎn)該藥品。 A new medicine which has pleted its clinical tests and been approved after appraisal shall be issued a certificate of new medicine by the pharmaceutical supervisory and administrative department under the State Council. 第三十條 藥物的非臨床安全性評價研究機構和臨床試驗機構必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)范。 12 Article 27 Prescriptions being dispensed by the dispensers of medical anizations must be checked. Pharmaceuticals listed in prescriptions 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. 第二十八條 醫(yī)療機構必須制定和執(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 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)療機構配制的制劑，不得在市場銷售。 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)療機構配制制劑，必須具有能夠保證制劑質(zhì)量的設施、管理制度、檢驗儀器和衛(wèi)生條件。非藥學技術人員不得直接從事藥劑技術工作。 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。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。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 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》應當標明有效期和經(jīng)營范圍，到期重新審查發(fā)證。 Article 12 The pharmaceutical producing enterprises must conduct q