【正文】 ith the Drug Supply Certificate , the wholesaler and the retailer shall beregistered with the administrative agency for industry and merce.《藥品經(jīng)營許可證》的，不得經(jīng)營藥品。 The valid period and the scope of business shall be indicated in the DrugSupply Certificate. For renewal of the certificate upon expiration,reviewing and approval again is required.： （一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員；（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(chǔ)設(shè)施、衛(wèi)生環(huán)境；（三）具有與所經(jīng)營藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；（四）具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。(2) provided with the business operation premises, equipment,warehouses, and clear environment required for drug distribution。 and(4) establishing rules and regulations to govern the qualityof the drugs to be distributed.《藥品經(jīng)營質(zhì)量管理規(guī)范》經(jīng)營藥品。 The drug regulatory agency inspect a drug distributor as to its pliancewith the GSP requirements, and issue a certificate to the distributorpassing the inspection.，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)。 no drugs that fail to meet therequirements are permitted to be purchased.，必須有真實(shí)完整的購銷記錄。 In the record shall be indicated the adopted name of drugs, dosage form,strength or size, batch number, date of expiry, manufacturer, purchaser (orseller), amount of the drug purchased (or sold), purchase or selling price,date of purchase (or sale) , and other items specified by the drugregulatory agency of the State Council.，必須標(biāo)明產(chǎn)地。 A drug distributor shall pass the established system for drug storage, andtake necessary measures to ensure drug quality, such as cold storing,protecting from being frozen and moisture and guarding against insects androdents.。 Chinese crude drugs may be sold at fairs in urban and rural areas, exceptthose otherwise specified by the State Council.，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(diǎn)出售中藥材以外的藥品。Dispensing pharmaceutical preparations by a medical institution shall besubject to reviewing and permission by the health administration agency ofthe government of the province, autonomous region or municipality directlyunder the Central Government, and upon approval by the drug regulatoryagency of the government. A Pharmaceutical Preparation Certificate forMedical Institution shall be issued by the above drug regulatory agency.《醫(yī)療機(jī)構(gòu)制劑許可證》的醫(yī)療機(jī)構(gòu)，不得配制制劑。 The term of validation shall be noted in the Pharmaceutical PreparationCertificate for Medical Institution. For renewal of the certificate uponexpiration, reviewing and approval again is required.，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。 No pharmaceutical preparations dispensed by medical institutions arepermitted to be marketed.，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)。 When a new drug has gone through clinical trials and passed the reviewing, aNew Drug Certificate shall be issued upon approval by the drug regulatoryagency of the State Council.量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。Production of a new drug or production of a drug plying with NationalDrug Standards shall be subject to the approval by the drug regulatoryagency of the State Council, and a drug approval number shall be issued forit, with the exception of the Chinese crude drugs and the prepared slices ofChinese crude drugs in which no control by approval number is exercised. 、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。 A drug manufacturer is permitted to produce the drug only after an approvalnumber has been granted to it.71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。The Pharmacopoeia of the People39。 The drug regulatory agency of the State Council shall organize apharmacopoeia mission, which shall be responsible for formulating andrevising the National Drug Standards.、對(duì)照品。 Drug manufacturers, drug distributors and medical institutions shallpurchase drugs from pharmaceutical enterprises, which are qualified forproduction and distribution, with the exception of the Chinese crude drugsin which no control by approval number is exercised.、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。The State adopts a protection system for certain traditional Chinesemedicines.。 Reviewing the drugs to be imported shall e of the jurisdiction of thedrug regulatory agency of the State Council. A drug is permitted to beimported only upon approval granted after confirming that it conforms to thequality, safely and efficiency through examination, and a drug importationlicense shall be issued.。 When major disasters, epidemic situations or other emergencies occur in thecountry, the department designated by the State Council may allocate drugsfrom the enterprises to meet the urgent need.82. 禁止生產(chǎn)（包括配制）、銷售假藥。 （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷售的； It is produced or imported without approval, or marketed without beingtested, as required by the Law。（四）被污染的； It is contaminated。 （六）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。 Production and distribution of drugs of inferior quality are prohibited.，為劣藥。（二）不注明或者更改生產(chǎn)批號(hào)的； The batch number is not indicated or is altered。（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的； No approval certificate is obtained for the immediate packaging material orcontainer。 or（六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標(biāo)使用。Staff members of drug manufacturers, drug distributors and medicalinstitutions who make a direct contact with drugs shall receive physicalexamination annually.，不得從事直接接觸藥品的工作。 Immediate packaging materials and containers shall meet the requirements formedicinal use and ply with the standards for ensuring human health andsafety. They along with the drugs shall be subject to reviewing and approvalby the drug regulatory agency.92. 藥品包裝必須按照規(guī)定印有或者貼有標(biāo)簽并附有說明書。 In the label or insert sheet shall be indicated the adopted name of thedrug, its ingredients, strength, manufacturer, approval number, productbatch number, production date, date of expiry, indications or functions,usage, dosage, contraindications, drug adverse reactions, and precautions.、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品