【正文】 directly under the Central Government and be granted the DrugSupply Certificate.，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(zhǔn)并發(fā)給《藥品經(jīng)營許可證》。Any newly established drug retailer shall be subject to approval and begranted the above certificate by the local drug regulatory agency at orabove the county level.47. 藥品批發(fā)、零售企業(yè)憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊。With 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。 No one is permitted to distribute drugs without the certificate.48.《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 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。 A drug distributor to be established shall meet the followingrequirements:(1) staffed with legally qualified pharmaceuticalprofessionals。(2) provided with the business operation premises, equipment,warehouses, and clear environment required for drug distribution。(3) havingthe quality control units or personnel adaptable the drugs to bedistributed。 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。Drug distributors shall conduct business according to the Good SupplyPractice for Pharmaceutical Products (GSP) set by the drug regulatory agencyof the State Council based on this Law.《藥品經(jīng)營質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對認(rèn)證合格的，發(fā)給認(rèn)證證書。 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)。 After receiving the drug purchased, drug distributors shall pass theestablished examination and acceptance system, and check the certificate ofdrug quality, labels and others marks。 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。Drug distributors shall keep a real and perfect records of purchasing andselling drugs.、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(jià)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。 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。 Drug distributors shall indicate the habitat of Chinese crude drugs to besold.，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。 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.。 An examination system shall be followed for storing drugs in warehouse andreleasing them from warehouse.，國務(wù)院另有規(guī)定的除外。 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。 No drugs other than the Chinese crude drugs may be sold at fairs in urbanand rural areas, but drug retailers holding the Drug Supply Certificate may,within the specified business scope, sell such drugs at the stores they setup at the fairs.，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》。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。 No medical institution is permitted to dispense pharmaceutical preparationswithout the Pharmaceutical Preparation Certificate for Medical Institution.62.《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。 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。The pharmaceutical preparations to be dispensed by the medical institutionshall be those satisfying the clinic need of the institution but notavailable on the market. It shall be subject to approval in advance by thelocal drug regulatory agency of the government of the province, autonomousregion or municipality directly under the Central Government.，不得在市場銷售。 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)。A full description of a new drug research and development including themanufacturing process, quality specifications, results of pharmacologicaland toxicological study, and the related data as well as the samples shall,in accordance with the regulations of the drug regulatory agency of theState Council, be truthfully submitted to the above agency for reviewing andapproval.，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。 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。 The institutions for nonclinical safety evaluation and study and forclinical study institutions shall respectively follow the Good LaboratoryPractice for NonClinical Laboratory Studies (GLP) and Good ClinicalPractice (GCP).，須經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給