药学专业英语

1、精选文档medicine；drug；remedy药sleepingpill安息药contraceptivedrugs避孕药tonic补药amedicineforcolds感冒药expectorant化痰药anti-cancerdrugs；cancer-fightingdrugs抗癌药anti-tuberculousdrug抗结核药oralcontraceptive；pill口服避孕药goodmedicine；agoodremedy良药laxative轻泻药antipyretic退热药fororaladministration内服药specificmedicine；specific殊效药fore

2、xternaluse外用药preventivemedicine；prophylactic预防药sedative冷静药takemedicine服药changedressings换药decoctherbalmedicine煎药fillaprescription配药haveaprescriptionmadeup（filled）（患者）抓药medicinalmaterials；crudedrugs药材medicinalherbs药草tablet药片medicinesandchemicalreagents药品medicinebottle药瓶remedies药石.精选文档liquidmedicine；me

3、dicinalliquid药水lotion洗液pill药丸bolus大药丸herbalmedicinesinaprescription药味（中药方中的药）flavorofadrug药味（药的滋味或气味）medicines；pharmaceuticals；medicaments药物healwithdrugs药物医治drugallergy药物过敏materiamedica药物学drugpoisoning药物中毒medicinal）powder药粉ointment；salve药膏applyaplaster上药膏medicalapparatusandinstruments：医疗器材pharmaceut

4、icalfactory：药厂drugstore；chemistsshop；pharmacy：药店pharmacopeia：药典prescription：药方writeoutaprescription：开药方drugstore；chemistsshop；pharmacy：医药商店hospitalpharmacy；dispensary：医院或诊所里的药房expensesformedicine；chargesformedicine：药费apotfordecoctingherbalmedicine：药罐子chronicinvalid：药罐子（常常生病的人）apothecariesmeasureorwe

5、ight：药衡medicinalherbcollector；herbalist：药农herbalmedicineshop：药铺.精选文档asthma哮喘pneumonia肺炎heartdisease心脏病arrhythmia心律不齐indigestion消化不良gastritis胃炎appendicitis盲肠炎hepatitis肝炎dermatitis皮炎freckle/ephelis痣，斑点acne粉刺flu流感diarrhoea痢疾quarantine检疫vaccinate打疫苗endemic不服水土relapse复发症casualty急症stupor昏迷sprain扭伤scalding

6、烫伤graze擦伤scratch搔挠trauma外伤bruise淤伤fracture骨折dislocation脱臼tinnitus耳鸣.精选文档trachoma沙眼colourblindness色盲nearsightedness/myopia近视astigmatism散光gingivitis牙龈炎cavity蛀牙fever发热discomfort/disorder不适malnutrition营养不良incubation隐藏期asthenia虚弱poisoning中毒fatigue疲惫heatstroke中暑itching发痒ache/pain痛tetanus破伤风nightsweat盗汗chi

7、ll打冷战pale神色发白shuddering发抖inflammation炎症acute急症chronic慢性病congenital先本性病nausea恶心vomit呕吐.精选文档常用药品看守英语与缩略语浙江省药品督查管理局政策法规处一、看守英语中华人民共和国药品管理法DrugControlLawofthePeoplesRepublicofChina药品生产企业管理controloverdrugmanufacturers药品经营企业管理controloverdrugdistributors医疗机构的药剂管理controlovermedicinesinmedicalinstitutions药品管

8、理controloverdrugs药品包装的管理.精选文档controloverdrugpackaging药品价格和广告的管理controloverdrugpriceandadvertisement药品督查inspectionofdrugs法律责任legalliabilities药品表记labelsormarksofthedrugs假药counterfeitdrugs劣药inferiordrugs.精选文档药品检验机构drugqualitycontrollaboratory药品的生产企业drugmanufacturers经营企业drugdistributors医疗机构medicalinstit

9、utions药品督查管理部门drugregulatoryagency药品赞同证明文件drugapprovaldocuments行政处罚administrativesanctions.精选文档刑事责任criminalliabilities药品生产质量管理规范GoodManufacturingPracticeforPharmaceuticalProducts(GMP)药品经营质量管理规范GoodSupplyPracticeforPharmaceuticalProducts(GSP)药品生产允许证DrugManufacturingCertificate药品经营允许证DrugSupplyCertifi

10、cate医疗机构制剂允许证PharmaceuticalPreparationCertificateforMedicalInstitution进口药品注册证书.精选文档ImportDrugLicense临床试验clinicaltrial新药证书NewDrugCertificate药品赞同文号DrugApprovalNumber30.在中华人民共和国境内从事药品的研制、生产、经营、使用和督查管理的单位也许个人，一定遵守中华人民共和国药品管理法Allinstitutionsorindividualsengagedinresearch,production,distribution,use,andad

11、ministrationandsupervisionofdrugsinthePeoplesRepublicofChinashallabidebydrugcontrollawofthepeoplesrepublicofChina.国务院药品督查管理部门主管全国药品督查管理工作。ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.精选文档省、自治区、直辖市人民政府药品督查管理部门负责本行政地区内的药品督查管理工作。Thedrugregulato

12、ryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.药品督查管理部门设置也许确立的药品检验机构，担当依法实行药品审批和药质量量督查检查所需的药品检验工作。Thedrugqualitycontrollaboratoriesestablishedordesignatedbydrugregulatoryagenciess

13、hallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualitypursuanttothelaw.创立药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品督查管理部门赞同并发给药品生产允许证，凭药品生产允许证到工商行政管理部门办理登记注册。Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoapprovalbythelocaldrugregulatoryagenc

14、yofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.精选文档药品生产允许证应当注明有效期和生产范围，到期重新审察发证。Thetermofvalidationandthe

15、scopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.药品督查管理部门赞同创立药品生产企业，应当切合国家拟订的药道德业发展规划和家产政策，防范重复建设。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagencyshallseetoitthatthedevelopmentprog

16、ramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.37.创立药品生产企业，一定具备以下条件：（一）拥有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人；（二）拥有与其药品生产相适应的厂房、设施和卫生环境；（三）拥有能对所生产药品进行质量管理和质量检验的机构、人员以及必需的仪器设施；（四）拥有保证药质量量的规章制度。Anydrugmanufacturertobeestablishedshallmeetthefollo

17、wingrequirements:stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;(2)providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;(3)havingqualitymanagementandcontrolunitsandpersonnelcapableofqualitymanagementofandtestingfordru

18、gstobeproducedandthenecessaryinstrumentsandequipment;and(4)establishingrulesandregulationstogovernthequalityofdrugs.精选文档药品生产企业一定依照国务院药品督查管理部门依照本法拟订的药品生产质量管理规范组织生产。药品督查管理部门依照规定对药品生产企业能否切合药品生产质量管理规范的要求进行认证；对认证合格的，发给认证证书。DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeProd

19、ucts(GMP)formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.除中药饮片的炮制外，药品一定依照国家药品标准和国务院药品督查管理部门赞同的生产工艺进行生产，生产记录一定完好正确。Withtheexceptionof

20、theprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.药品生产企业改变影响药质量量的生产工艺的，一定报原赞同部门审察赞同。Whendrugmanufacturersmakeany

21、changeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.精选文档生产药品所需的原料、辅料，一定切合药用要求。Activepharmaceuticalingredients(API)andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.药品生产企业一定对其生产的药品进行质

22、量检验。Drugmanufacturersshallperformqualitytestoftheirproducts.不切合国家药品标准也许不依照省、自治区、直辖市人民政府药品督查管理部门拟订的中药饮片炮制规范炮制的，不得出厂。NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatoryagencyofthegover

23、nmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.经国务院药品督查管理部门也许国务院药品督查管理部门受权的省、自治区、直辖市人民政府药品督查管理部门赞同，药品生产企业可以接受拜托生产药品。AdrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitisapprovedbythedrugregulatoryagencyoftheStateCouncil,orbythedrugregulat

24、oryagencyofthegovernmentofaprovince,autonomousregion,ormunicip.精选文档alitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.创立药品批发企业，须经企业所在地省、自治区、直辖市人民政府药品督查管理部门赞同并发给药品经营允许证.Anynewlyestablisheddrugwholesalershallbesubjecttoapprovalofthelocaldrugagencyofthegovernment

25、oftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.创立药品零售企业，须经企业所在地县级以上地方药品督查管理部门赞同并发给药品经营允许证。Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythelocaldrugregulatoryagencyatorabovethecountylevel.药品批

26、发、零售企业凭药品经营允许证到工商行政管理部门办理登记注册。WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.无药品经营允许证的，不得经营药品。.精选文档Nooneispermittedtodistributedrugswithoutthecertificate.药品经营允许证应当注明有效期和经营范围，到期重新审察发证。Thevalidperiodandthescopeofbusinessshallb

27、eindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.49.创立药品经营企业一定具备以下条件：（一）拥有依法经过资格认定的药学技术人员；（二）拥有与所经营药品相适应的营业场所、设施、仓储设施、卫生环境；（三）拥有与所经营药品相适应的质量管理机构也许人员；（四）拥有保证所经营药质量量的规章制度。Adrugdistributortobeestablishedshallmeetthefollowingrequirements:(

28、1)staffedwithlegallyqualifiedpharmaceuticalprofessionals;(2)providedwiththebusinessoperationpremises,equipment,warehouses,andclearenvironmentrequiredfordrugdistribution;(3)havingthequalitycontrolunitsorpersonneladaptablethedrugstobedistributed;and(4)establishingrulesandregulationstogovernthequalityo

29、fthedrugstobedistributed.药品经营企业一定依照国务院药品督查管理部门依照本法拟订的药品经营质量管理规范经营药品。DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts(GSP)setbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.精选文档药品督查管理部门依照规定对药品经营企业能否切合药品经营质量管理规范的要求进行认证；对认证合格的，发给认证证书。Thedrugregulato

30、ryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.药品经营企业购进药品，一定建立并履行进货检查查收制度，验明药品合格证明和其余表记；不切合规定要求的，不得购进。Afterreceivingthedrugpurchased,drugdistributorsshallpasstheestablishedexaminationandacceptancesystem,andcheckthecerti

31、ficateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedtobepurchased.药品经营企业购销药品，一定有真实完好的购销记录。Drugdistributorsshallkeeparealandperfectrecordsofpurchasingandsellingdrugs.购销记录一定注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购（销）货单位、购（销）货数目、购销价格、购（销）货日期及国务院药品督查管理部门规定的其余内容。.精选文档Intherecord

32、shallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser(orseller),amountofthedrugpurchased(orsold),purchaseorsellingprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulatoryagencyoftheStateCouncil.药品经营企业销售中药材，一定注明产地。Drugdistributor

33、sshallindicatethehabitatofChinesecrudedrugstobesold.药品经营企业一定拟订和执行药品保留束度，采纳必需的冷藏、防冻、防潮、防虫、防鼠等措施，保证药质量量。Adrugdistributorshallpasstheestablishedsystemfordrugstorage,andtakenecessarymeasurestoensuredrugquality,suchascoldstoring,protectingfrombeingfrozenandmoistureandguardingagainstinsectsandrodents.药品入库

34、和出库一定执行检查制度。Anexaminationsystemshallbefollowedforstoringdrugsinwarehouseandreleasingthemfromwarehouse.城乡市集贸易市场可以销售中药材，国务院还有规定的除外。.精选文档Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCouncil.城乡市集贸易市场不得销售中药材之外的药品，但拥有药品经营允许证的药品零售企业在规定的范围内可以在城乡市集贸易市场设点销售中药材之外

35、的药品。NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheysetupatthefairs.医疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部门审察赞同，由省、自治区、直辖市人民政府药品督查管理部门赞同，发给医疗机构制剂允许证。Dispensingpharmaceuti

36、calpreparationsbyamedicalinstitutionshallbesubjecttoreviewingandpermissionbythehealthadministrationagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,anduponapprovalbythedrugregulatoryagencyofthegovernment.APharmaceuticalPreparationCertificateforMedica

37、lInstitutionshallbeissuedbytheabovedrugregulatoryagency.无医疗机构制剂允许证的医疗机构，不得配制制剂。NomedicalinstitutionispermittedtodispensepharmaceuticalpreparationswithoutthePharmaceuticalPreparationCertificateforMedicalInstitution.精选文档医疗机构制剂允许证应当注明有效期，到期重新审察发证。ThetermofvalidationshallbenotedinthePharmaceuticalPrepar

38、ationCertificateforMedicalInstitution.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.医疗机构配制的制剂，应当是本单位临床需要而市场上没有供应的品种，并须经所在地省、自治区、直辖市人民政府药品督查管理部门赞同后方可配制。Thepharmaceuticalpreparationstobedispensedbythemedicalinstitutionshallbethosesatisfyingtheclinicneedoftheinstitutionbu

39、tnotavailableonthemarket.Itshallbesubjecttoapprovalinadvancebythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.医疗机构配制的制剂，不得在市场销售。Nopharmaceuticalpreparationsdispensedbymedicalinstitutionsarepermittedtobemarketed.研制新药，一定依照国务院药品督查

40、管理部门的规定照实报送研制方法、质量指标、药理及毒理试验结果等相关资料和样品，经国务院药品督查管理部门赞同后，方可进行临床试验。.精选文档Afulldescriptionofanewdrugresearchanddevelopmentincludingthemanufacturingprocess,qualityspecifications,resultsofpharmacologicalandtoxicologicalstudy,andtherelateddataaswellasthesamplesshall,inaccordancewiththeregulationsofthedrugre

41、gulatoryagencyoftheStateCouncil,betruthfullysubmittedtotheaboveagencyforreviewingandapproval.完成临床试验并经过审批的新药，由国务院药品督查管理部门赞同，发给新药证书。Whenanewdrughasgonethroughclinicaltrialsandpassedthereviewing,aNewDrugCertificateshallbeissueduponapprovalbythedrugregulatoryagencyoftheStateCouncil.药物的非临床安全性议论研究机构和临床试验机

42、构一定分别执行药物非临床研究质量管理规范、药物临床试验质量管理规范。Theinstitutionsfornon-clinicalsafetyevaluationandstudyandforclinicalstudyinstitutionsshallrespectivelyfollowtheGoodLaboratoryPracticeforNon-ClinicalLaboratoryStudies(GLP)andGoodClinicalPractice(GCP).生产新药也许已有国家标准的药品的，须经国务院药品督查管理部门赞同，并发给药品赞同文号；但是，生产没有实行赞同文号管理的中药材和中药饮片

43、除外。ProductionofanewdrugorproductionofadrugcomplyingwithNationalDrugStandardsshallbesubjecttotheapprovalbythedrugregulatoryagencyoftheStateCouncil,andadrugapprovalnumbershallbeissuedforit,withtheexce.精选文档ptionoftheChinesecrudedrugsandthepreparedslicesofChinesecrudedrugsinwhichnocontrolbyapprovalnumbe

44、risexercised.实行赞同文号管理的中药材、中药饮片品种目录由国务院药品督查管理部门会同国务院中医药管理部门拟订。ThelistoftheChinesecrudedrugsandthepreparedslicesoftheChinesecrudedrugstobecontrolledbytheapprovalnumbershallbecompiledbythedrugregulatoryagencyoftheStateCouncil,jointlywiththeadministrativeagencyfortraditionalChinesemedicinesoftheStateCou

45、ncil.药品生产企业在获得药品赞同文号后，方可生产该药品。Adrugmanufacturerispermittedtoproducethedrugonlyafteranapprovalnumberhasbeengrantedtoit.药品一定切合国家药品标准。DrugsshallcomplywiththeNationalDrugStandards.国务院药品督查管理部门宣告的中华人民共和国药典和药品标准为国家药品标准。ThePharmacopoeiaofthePeoplesRepublicofChinaandtheDrugStandardsissuedbythedrugregulatorya

46、gencyoftheStateCouncilshallserveastheNationalDrugStandards.精选文档国务院药品督查管理部门组织药典委员会，负责国家药品标准的拟订和订正。ThedrugregulatoryagencyoftheStateCouncilshallorganizeapharmacopoeiacommission,whichshallberesponsibleforformulatingandrevisingtheNationalDrugStandards.国务院药品督查管理部门的药品检验机构负责标定国家药品标准品、比较品。Thedrugcontrolinst

47、itutionaffiliatedtothedrugregulatoryagencyoftheStateCouncilisresponsibleforstandardizingtheNationalDrugStandardSubstanceandReferenceSubstance.药品生产企业、药品经营企业、医疗机构一定从拥有药品生产、经营资格的企业购进药品；但是，购进没有实行赞同文号管理的中药材除外。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallpurchasedrugsfrompharmaceuticalente

48、rprises,whicharequalifiedforproductionanddistribution,withtheexceptionoftheChinesecrudedrugsinwhichnocontrolbyapprovalnumberisexercised.国家对麻醉药品、精神药品、医疗用毒性药品、放射性药品，实行特别管理。TheStateexercisesspecialcontrolovernarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluseandradioactivepharmaceuticals.精选文档国

49、家实行中药品种保护制度。TheStateadoptsaprotectionsystemforcertaintraditionalChinesemedicines.国家对药品实行处方药与非处方药分类管理制度。TheStateadoptsasystemofclassifiedmanagementforprescriptionandnon-prescriptiondrugs.药品进口，须经国务院药品督查管理部门组织审察，经审察确认切合质量标准、安全有效的，方可赞同进口，并发给进口药品注册证书。Reviewingthedrugstobeimportedshallcomeofthejurisdictio

50、nofthedrugregulatoryagencyoftheStateCouncil.Adrugispermittedtobeimportedonlyuponapprovalgrantedafterconfirmingthatitconformstothequality,safelyandefficiencythroughexamination,andadrugimportationlicenseshallbeissued.国家实行药品贮备制度。TheStateadoptsapolicyfordrugstorageforfutureuse.81.国内发生重要灾情、疫情及其余突发事件时，国务院

51、规定的部门可以紧急调用企业药品。.精选文档Whenmajordisasters,epidemicsituationsorotheremergenciesoccurinthecountry,thedepartmentdesignatedbytheStateCouncilmayallocatedrugsfromtheenterprisestomeettheurgentneed.严禁生产（包含配制）、销售假药。Production(includingdispensing)anddistributionofcounterfeitdrugsareprohibited.有以下情况之一的，为假药：Adrug

52、fallingintothefollowingcategoriesisdeemedasacounterfeitdrug:（一）药品所含成份与国家药品标准规定的成份不符的；TheingredientsinthedrugaredifferentfromthosespecifiedbytheNationalDrugStandards;（二）以非药品冒充药品也许以他种药品冒充此种药品的。Itisnotthesamedrugwhichisclaimedbyitsnameorinrealityitisnotadrugatall.有以下情况之一的药品，按假药论处：Adrugfallingintothefol

53、lowingcategoriesshallbedeemedasacounterfeitdrug:（一）国务院药品督查管理部门规定严禁使用的；.精选文档ItsuseisprohibitedbytheprovisionsofthedrugregulatoryagencyoftheStateCouncil;（二）依照本法一定赞同而未经赞同生产、进口，也许依照本法一定检验而未经检验即销售的；Itisproducedorimportedwithoutapproval,ormarketedwithoutbeingtested,asrequiredbytheLaw;（三）变质的；Itisdeteriorat

54、ed;（四）被污染的；Itiscontaminated;（五）使用依照本法一定获得赞同文号而未获得赞同文号的原料药生产的；ItisproducedbyusingactivepharmaceuticalingredientswithoutapprovalnumberasrequiredbythisLaw;（六）所注明的适应症也许功能主治超出规定范围的。Theindicationsorfunctionsindicatedarebeyondthespecifiedscope.严禁生产、销售劣药。Productionanddistributionofdrugsofinferiorqualityarep

55、rohibited.药品成份的含量不切合国家药品标准的，为劣药。.精选文档AdrugwithcontentnotuptotheNationalDrugStandardsisadrugofinferiorquality.有以下情况之一的药品，按劣药论处：Adrugfallingintothefollowingcategoriesshallbedeemedasadrugofinferiorquality:（一）未注明有效期也许改正有效期的；Thedateofexpiryisnotindicatedorisaltered;（二）不注明也许改正生产批号的；Thebatchnumberisnotindi

56、catedorisaltered;（三）超出有效期的；Itisbeyondthedateofexpiry;（四）直接接触药品的包装资料和容器未经赞同的；Noapprovalcertificateisobtainedfortheimmediatepackagingmaterialorcontainer;（五）擅自增加着色剂、防腐剂、香料、矫味剂及辅料的；Colorants,preservatives,spices,flavorings,orotherrecipientshavebeenaddedwithoutauthorization;or（六）其余不切合药品标准规定的。Othercaseswh

57、erethedrugstandardsarenotcompliedwith.精选文档列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的，该名称不得作为药品商标使用。AdrugnamelistedintheNationalDrugStandardsisanadoptednameinChina.Suchanadoptednameisnotpermittedtobeusedasatrademark.药品生产企业、药品经营企业和医疗机构直接接触药品的工作人员，一定每年进行健康检查。Staffmembersofdrugmanufacturers,drugdistributorsandmed

58、icalinstitutionswhomakeadirectcontactwithdrugsshallreceivephysicalexaminationannually.患有传得病也许其余可能污染药品的疾病的，不得从事直接接触药品的工作。Thosewhosufferfrominfectiousdiseasesoranyotherdiseasesthatmaycausedrugcontaminationarenotpermittedtoundertakeanyjobindirectcontactwithdrugs.直接接触药品的包装资料和容器，一定切合药用要求，切合保障人体健康、安全的标准，并

59、由药品督查管理部门在审批药品时一并审批。Immediatepackagingmaterialsandcontainersshallmeettherequirementsformedicinaluseandcomplywiththestandardsforensuringhumanhealthandsafety.精选文档Theyalongwiththedrugsshallbesubjecttoreviewingandapprovalbythedrugregulatoryagency.药品包装一定依照规定印有也许贴有标签并附有说明书。Alabelshallbeprintedorstuckonthe

60、drugpackagewithaninsertsheetattachedasrequiredbyregulations.标签也许说明书上一定注明药品的通用名称、成份、规格、生产企业、赞同文号、产品批号、生产日期、有效期、适应症也许功能主治、用法、用量、禁忌、不良反响和注意事项。Inthelabelorinsertsheetshallbeindicatedtheadoptednameofthedrug,itsingredients,strength,manufacturer,approvalnumber,productbatchnumber,productiondate,dateofexpiry