【正文】 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(yàn)費(fèi)項(xiàng)目和收費(fèi)標(biāo)準(zhǔn)由國務(wù)院財(cái)政部門會(huì)同國務(wù)院價(jià)格主管部門核定并公告。 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(jìn)口的口岸由國務(wù)院藥品監(jiān)督管理部門會(huì)同海關(guān)總署提出，報(bào)國務(wù)院批準(zhǔn)。無《進(jìn)口藥品通關(guān)單》的，海關(guān)不得放行。 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(jìn)口的口岸進(jìn)口，并由進(jìn)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。s health shall be prohibited. 第三十九條 藥品進(jìn)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(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊證書。 Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people39。具體辦法由國務(wù)院制定。具體辦法由國務(wù)院制定。管理辦法由國務(wù)院制定。 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(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。 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(yàn)機(jī)構(gòu)負(fù)責(zé)標(biāo)定國家藥品標(biāo)準(zhǔn)品、對(duì)照品。39。 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(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)。 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(biāo)準(zhǔn)。實(shí)施批準(zhǔn)文號(hào)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(huì)同國務(wù)院中醫(yī)藥管理部門制定。 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(yàn)質(zhì)量管理規(guī)范由國務(wù) 院確定的部門制定。 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(yàn)并通過審批的新藥，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。 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(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)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(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。對(duì)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(shí)，經(jīng)處 方醫(yī)師 更正或者重新簽字，方可調(diào)配。 Medicinal preparations made by medical anizations may not be sold on the market. 第二十六條 醫(yī)療機(jī)構(gòu)購進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購進(jìn)和使用。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(zhǔn)，醫(yī)療機(jī)構(gòu)配制的制劑可以在指定的醫(yī)療機(jī)構(gòu)之間調(diào)劑使用。 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(jī)構(gòu)配制的制劑，應(yīng)當(dāng)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(zhǔn)后方可配制。 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 of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations. 《醫(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。 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(jī)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(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。 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(jī)構(gòu)的藥劑管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第二十二條 醫(yī)療機(jī)構(gòu)必須配備依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員。 Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be