常用藥品監(jiān)管英語與縮略語

1、常用藥品監(jiān)管英語與縮略語常用藥品監(jiān)管英語與縮略語浙江省藥品監(jiān)督管理局政策法規(guī)處一、監(jiān)管英語1. 中華人民共和國藥品管理法DrugControlLawofthePeople'sRepublicofChina2. 藥品生產企業(yè)管理controloverdrugmanufacturers3. 藥品經營企業(yè)管理controloverdrugdistributors4. 醫(yī)療機構的藥劑管理controlovermedicinesinmedicalinstitutions5. 藥品管理controloverdrugs6. 藥品包裝的管理controloverdrugpackaging7. 藥品價格

2、和廣告的管理controloverdrugpriceandadvertisement8. 藥品監(jiān)督inspectionofdrugs9. 法律責任legalliabilities10. 藥品標識labelsormarksofthedrugs11. 假藥counterfeitdrugs112. 劣藥inferiordrugs13. 藥品檢驗機構drugqualitycontrollaboratory14. 藥品的生產企業(yè)drugmanufacturers15. 經營企業(yè)drugdistributors16. 醫(yī)療機構medicalinstitutions17. 藥品監(jiān)督管理部門drugregul

3、atoryagency18. 藥品批準證明文件drugapprovaldocuments19. 行政處分administrativesanctions20. 刑事責任criminalliabilities21. 藥品生產質量管理規(guī)范GoodManufacturingPracticeforPharmaceuticalProducts(GMP)22. 藥品經營質量管理規(guī)范GoodSupplyPracticeforPharmaceuticalProducts(GSP)23. 藥品生產許可證DrugManufacturingCertificate224. 藥品經營許可證DrugSupplyCertif

4、icate25. 醫(yī)療機構制劑許可證PharmaceuticalPreparationCertificateforMedicalInstitution26. 進口藥品注冊證書ImportDrugLicense27. 臨床試驗clinicaltrial28. 新藥證書NewDrugCertificate29. 藥品批準文號DrugApprovalNumber30. 在中華人民共和國境內從事藥品的研制、生產、經營、使用和監(jiān)督管理的單位或者個人必須遵守中華人民共和國藥品管理法Allinstitutionsorindividualsengagedinresearch,production,distri

5、bution,use,andadministrationandsupervisionofdrugsinthePeople'sRepublicofChinashallabidebydrugcontrollawofthepeople'srepublicofChina.31. 國務院藥品監(jiān)督管理部門主管全國藥品監(jiān)督管理工作。ThedrugregulatoryagencyoftheStateCouncilshallberesponsiblefordrugadministrationandsupervisionnationwide.32. 省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負責本

6、行政區(qū)域內的藥品監(jiān)督管理工作。Thedrugregulatoryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.33. 藥品監(jiān)督管理部門設置或者確定的藥品檢驗機構承擔依法實施藥品審批和藥品質量監(jiān)督檢查所需的藥品檢驗工作。Thedrugqualitycontrollaboratoriesestablishedorde

7、signatedbydrugregulatoryagenciesshallundertaketheresponsibilityfordrugtestingrequiredforconducting3drugreviewandapprovalandcontrollingdrugqualitypursuanttothelaw.34. 開辦藥品生產企業(yè)須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給藥品生產許可證憑藥品生產許可證到工商行政管理部門辦理登記注冊。Anynewlyestablishedpharmaceuticalmanufacturershallbesubjecttoa

8、pprovalbythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativeagencyforindustryandcommerce.35.藥品生產許可證應當標明有效期和生產范圍

9、到期重新審查發(fā)證。ThetermofvalidationandthescopeofmanufacturingshallbenotedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reviewingandapprovalagainisrequired.藥品監(jiān)督管理部門批準開辦藥品生產企業(yè)應當符合國家制定的藥品行業(yè)36.發(fā)展規(guī)劃和產業(yè)政策防止重復建設。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagenc

10、yshallseetoitthatthedevelopmentprogramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.37 .開辦藥品生產企業(yè)必須具備以下條件：，一，具有依法經過資格認定的藥學技術人員、工程技術人員及相應的技術工人,二,具有與其藥品生產相適應的廠房、設施和衛(wèi)生環(huán)境,三,具有能對所生產藥品進行質量管理和質量檢驗的機構、人員以及必要的儀器設備,四,具有保證藥品質量的規(guī)章制度。Anydrugmanufacturer

11、tobeestablishedshallmeetthefollowingrequirements:(1)stuffedwithlegallyqualifiedpharmaceuticalandengineeringprofessionalsandthenecessarytechnicalworkers;(2)providedwiththepremises,facilities,andclearenvironmentrequiredfordrugmanufacturing;(3)havingqualitymanagementandcontrolunitsandpersonnelcapableof

12、qualitymanagementofandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and(4)establishingrulesandregulationstogovernthequalityofdrugs.38 .藥品生產企業(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制定的藥品生產質量管理規(guī)范組織生產。藥品監(jiān)督管理部門按照規(guī)定對藥品生產企業(yè)是否符合藥品生產質量管理規(guī)范的要求進行認證，對認證合格的發(fā)給認4證證書。Drugmanufacturersshallconductproductionaccordin

13、gtotheGoodManufacturingPracticeProducts(GMP)formulatedbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.ThedrugregulatoryagencyshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.39 .除中藥飲片的炮制外藥品必須按照國家藥品標準和國務院藥品監(jiān)督管理部門批準的

14、生產工藝進行生產生產記錄必須完整準確。WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.40 .藥品生產企業(yè)改變影響藥品質量的生產工藝的必

15、須報原批準部門審核批準。Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.41 .生產藥品所需的原料、輔料必須符合藥用要求。Activepharmaceuticalingredients(API)andrecipientsforthemanufactureofpharmaceuticalproductsshallmeettherequire

16、mentsformedicinaluse.42 .藥品生產企業(yè)必須對其生產的藥品進行質量檢驗。Drugmanufacturersshallperformqualitytestoftheirproducts.43 .不符合國家藥品標準或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的不得出廠。NoproductsthatdonotmeettheNationalDrugStandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrug

17、sformulatedbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.44 .經國務院藥品監(jiān)督管理部門或者國務院藥品監(jiān)督管理部門授權的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準藥品生產企業(yè)可以接受委托生產藥品。Adrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitis5approvedbythedrugre

18、gulatoryagencyoftheStateCouncil,orbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.45 .開辦藥品批發(fā)企業(yè)須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給藥品經營許可證.Anynewlyestablisheddrugwholesalershallbesubj

19、ecttoapprovalofthelocaldrugagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.46 .開辦藥品零售企業(yè)須經企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)給藥品經營許可證。Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythel

20、ocaldrugregulatoryagencyatorabovethecountylevel.47 .藥品批發(fā)、零售企業(yè)憑藥品經營許可證到工商行政管理部門辦理登記注冊。WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.47 .無藥品經營許可證的不得經營藥品。Nooneispermittedtodistributedrugswithoutthecertificate.48 .藥品經營許可證應當標明有效

21、期和經營范圍到期重新審查發(fā)證。ThevalidperiodandthescopeofbusinessshallbeindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.49 .開辦藥品經營企業(yè)必須具備以下條件:,一,具有依法經過資格認定的藥學技術人員,二,具有與所經營藥品相適應的營業(yè)場所、設備、倉儲設施、衛(wèi)生環(huán)境,三,具有與所經營藥品相適應的質量管理機構或者人員,四,具有保證所經營藥品質量的規(guī)章制度。Adrugdistrib

22、utortobeestablishedshallmeetthefollowingrequirements:(1)staffedwithlegallyqualifiedpharmaceuticalprofessionals;(2)providedwiththebusinessoperationpremises,equipment,warehouses,andclearenvironmentrequiredfordrugdistribution;(3)havingthequalitycontrolunitsorpersonneladaptablethedrugstobedistributed;an

23、d(4)establishingrulesandregulationstogovernthequalityofthedrugstobedistributed.650 .藥品經營企業(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制定的藥品經營質量管理規(guī)范經營藥品。DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts(GSP)setbythedrugregulatoryagencyoftheStateCouncilbasedonthisLaw.藥品監(jiān)督管理部門按照規(guī)定對藥品

24、經營企業(yè)是否符合藥品經營質量管理51.規(guī)范的要求進行認證，對認證合格的發(fā)給認證證書。ThedrugregulatoryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.52 .藥品經營企業(yè)購進藥品必須建立并執(zhí)行進貨檢查驗收制度驗明藥品合格證明和其他標識，不符合規(guī)定要求的不得購進。Afterreceivingthedrugpurchased,drugdistributorsshallpassthe

25、establishedexaminationandacceptancesystem,andcheckthecertificateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedtobepurchased.53 .藥品經營企業(yè)購銷藥品必須有真實完整的購銷記錄。Drugdistributorsshallkeeparealandperfectrecordsofpurchasingandsellingdrugs.54 .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、生產廠商

26、、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)定的其他內容。Intherecordshallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser(orseller),amountofthedrugpurchased(orsold),purchaseorsellingprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulato

27、ryagencyoftheStateCouncil.55 .藥品經營企業(yè)銷售中藥材必須標明產地。DrugdistributorsshallindicatethehabitatofChinesecrudedrugstobesold.56 .藥品經營企業(yè)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量。Adrugdistributorshallpasstheestablishedsystemfordrugstorage,andtakenecessarymeasurestoensuredrugquality,suchascoldstoring,protectingf

28、rombeingfrozenandmoistureandguardingagainstinsectsandrodents.57 .藥品入庫和出庫必須執(zhí)行檢查制度。Anexaminationsystemshallbefollowedforstoringdrugsinwarehouseandreleasingthemfromwarehouse.58 .城鄉(xiāng)集市貿易市場可以出售中藥材國務院另有規(guī)定的除外。Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCounci

29、l.59 .城鄉(xiāng)集市貿易市場不得出售中藥材以外的藥品但持有藥品經營許可證的藥品零售企業(yè)在規(guī)定的范圍內可以在城鄉(xiāng)集市貿易市場設點出售中藥材以外的藥品。NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheysetupatthefairs.60 .醫(yī)療機構配制制劑須經所在地省、自治區(qū)、直轄市

30、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)督管理部門批準發(fā)給醫(yī)療機構制劑許可證。Dispensingpharmaceuticalpreparationsbyamedicalinstitutionshallbesubjecttoreviewingandpermissionbythehealthadministrationagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,anduponapprovalbythedrugregulat

31、oryagencyofthegovernment.APharmaceuticalPreparationCertificateforMedicalInstitutionshallbeissuedbytheabovedrugregulatoryagency.61 .無醫(yī)療機構制劑許可證的醫(yī)療機構不得配制制劑。NomedicalinstitutionispermittedtodispensepharmaceuticalpreparationswithoutthePharmaceuticalPreparationCertificateforMedicalInstitution.62 .醫(yī)療機構制劑許可

32、證應當標明有效期到期重新審查發(fā)證。ThetermofvalidationshallbenotedinthePharmaceuticalPreparationCertificateforMedicalInstitution.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.63 .醫(yī)療機構配制的制劑應當是本單位臨床需要而市場上沒有供應的品種并須經所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準后方可配制。Thepharmaceuticalpreparationstobedispensedb

33、ythemedicalinstitutionshallbe8thosesatisfyingtheclinicneedoftheinstitutionbutnotavailableonthemarket.Itshallbesubjecttoapprovalinadvancebythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.64 .醫(yī)療機構配制的制劑不得在市場銷售。65.Nopharmaceuticalp

34、reparationsdispensedbymedicalinstitutionsarepermittedtobemarketed.研制新藥必須按照國務院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質量指標、藥理及毒理試驗結果等有關資料和樣品經國務院藥品監(jiān)督管理部門批準后方可進行臨床試驗。Afulldescriptionofanewdrugresearchanddevelopmentincludingthemanufacturingprocess,qualityspecifications,resultsofpharmacologicalandtoxicologicalstudy,andthere

35、lateddataaswellasthesamplesshall,inaccordancewiththeregulationsofthedrugregulatoryagencyoftheStateCouncil,betruthfullysubmittedtotheaboveagencyforreviewingandapproval.66. 完成臨床試驗并通過審批的新藥由國務院藥品監(jiān)督管理部門批準發(fā)給新藥證書。Whenanewdrughasgonethroughclinicaltrialsandpassedthereviewing,aNewDrugCertificateshallbeissued

36、uponapprovalbythedrugregulatoryagencyoftheStateCouncil.67. 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量管理規(guī)范、藥物臨床試驗質量管理規(guī)范。Theinstitutionsfornon-clinicalsafetyevaluationandstudyandforclinicalstudyinstitutionsshallrespectivelyfollowtheGoodLaboratoryPracticeforNon-ClinicalLaboratoryStudies(GLP)andGoodClinicalP

37、ractice(GCP).68. 生產新藥或者已有國家標準的藥品的須經國務院藥品監(jiān)督管理部門批準并發(fā)給藥品批準文號，但是生產沒有實施批準文號管理的中藥材和中藥飲片除外。ProductionofanewdrugorproductionofadrugcomplyingwithNationalDrugStandardsshallbesubjecttotheapprovalbythedrugregulatoryagencyoftheStateCouncil,andadrugapprovalnumbershallbeissuedforit,withtheexceptionoftheChinesecrud

38、edrugsandthepreparedslicesofChinesecrudedrugsinwhichnocontrolbyapprovalnumberisexercised.69. 實施批準文號管理的中藥材、中藥飲片品種目錄由國務院藥品監(jiān)督管理部9門會同國務院中醫(yī)藥管理部門制定。ThelistoftheChinesecrudedrugsandthepreparedslicesoftheChinesecrudedrugstobecontrolledbytheapprovalnumbershallbecompiledbythedrugregulatoryagencyoftheStateCoun

39、cil,jointlywiththeadministrativeagencyfortraditionalChinesemedicinesoftheStateCouncil.70. 藥品生產企業(yè)在取得藥品批準文號后方可生產該藥品。Adrugmanufacturerispermittedtoproducethedrugonlyafteranapprovalnumberhasbeengrantedtoit.71. 藥品必須符合國家藥品標準。DrugsshallcomplywiththeNationalDrugStandards.72. 國務院藥品監(jiān)督管理部門頒布的中華人民共和國藥典和藥品標準為國家藥

40、品標準。ThePharmacopoeiaofthePeople'sRepublicofChinaandtheDrugStandardsissuedbythedrugregulatoryagencyoftheStateCouncilshallserveastheNationalDrugStandards.73. 國務院藥品監(jiān)督管理部門組織藥典委員會負責國家藥品標準的制定和修訂。ThedrugregulatoryagencyoftheStateCouncilshallorganizeapharmacopoeiacommission,whichshallberesponsibleforfor

41、mulatingandrevisingtheNationalDrugStandards.74. 國務院藥品監(jiān)督管理部門的藥品檢驗機構負責標定國家藥品標準品、對照品。ThedrugcontrolinstitutionaffiliatedtothedrugregulatoryagencyoftheStateCouncilisresponsibleforstandardizingtheNationalDrugStandardSubstanceandReferenceSubstance.75. 藥品生產企業(yè)、藥品經營企業(yè)、醫(yī)療機構必須從具有藥品生產、經營資格的企業(yè)購進藥品，但是購進沒有實施批準文號管理

42、的中藥材除外。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallpurchasedrugsfrompharmaceuticalenterprises,whicharequalifiedforproductionanddistribution,withtheexceptionoftheChinesecrudedrugsinwhichnocontrolbyapprovalnumberisexercised.76. 國家對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品實行特殊管10理。TheStateexercisesspeci

43、alcontrolovernarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluseandradioactivepharmaceuticals.77. 國家實行中藥品種保護制度。TheStateadoptsaprotectionsystemforcertaintraditionalChinesemedicines.78. 國家對藥品實行處方藥與非處方藥分類管理制度。TheStateadoptsasystemofclassifiedmanagementforprescriptionandnon-prescriptiondrugs.79

44、. 藥品進口須經國務院藥品監(jiān)督管理部門組織審查經審查確認符合質量標準、安全有效的方可批準進口并發(fā)給進口藥品注冊證書。ReviewingthedrugstobeimportedshallcomeofthejurisdictionofthedrugregulatoryagencyoftheStateCouncil.Adrugispermittedtobeimportedonlyuponapprovalgrantedafterconfirmingthatitconformstothequality,safelyandefficiencythroughexamination,andadrugimpor

45、tationlicenseshallbeissued.80. 國家實行藥品儲備制度。TheStateadoptsapolicyfordrugstorageforfutureuse.81. 國內發(fā)生重大災情、疫情及其他突發(fā)事件時國務院規(guī)定的部門可以緊急調用企業(yè)藥品。Whenmajordisasters,epidemicsituationsorotheremergenciesoccurinthecountry,thedepartmentdesignatedbytheStateCouncilmayallocatedrugsfromtheenterprisestomeettheurgentneed.8

46、2. 禁止生產,包括配制,、銷售假藥。Production(includingdispensing)anddistributionofcounterfeitdrugsareprohibited.83. 有下列情形之一的為假藥：Adrugfallingintothefollowingcategoriesisdeemedasacounterfeitdrug:,一,藥品所含成份與國家藥品標準規(guī)定的成份不符的,TheingredientsinthedrugaredifferentfromthosespecifiedbytheNationalDrugStandards;,二,以非藥品冒充藥品或者以他種藥

47、品冒充此種藥品的。Itisnotthesamedrugwhichisclaimedbyitsnameorinrealityitisnotadrugat11all.84 .有下列情形之一的藥品按假藥論處：Adrugfallingintothefollowingcategoriesshallbedeemedasacounterfeitdrug:,一,國務院藥品監(jiān)督管理部門規(guī)定禁止使用的,ItsuseisprohibitedbytheprovisionsofthedrugregulatoryagencyoftheStateCouncil;,二,依照本法必須批準而未經批準生產、進口或者依照本法必須檢驗

48、而未經檢驗即銷售的,Itisproducedorimportedwithoutapproval,ormarketedwithoutbeingtested,asrequiredbytheLaw;,三,變質的,Itisdeteriorated;,四,被污染的,Itiscontaminated;,五,使用依照本法必須取得批準文號而未取得批準文號的原料藥生產的ItisproducedbyusingactivepharmaceuticalingredientswithoutapprovalnumberasrequiredbythisLaw;,六,所標明的適應癥或者功能主治超出規(guī)定范圍的。Theindic

49、ationsorfunctionsindicatedarebeyondthespecifiedscope.85 .禁止生產、銷售劣藥。Productionanddistributionofdrugsofinferiorqualityareprohibited.86 .藥品成份的含量不符合國家藥品標準的為劣藥。AdrugwithcontentnotuptotheNationalDrugStandardsisadrugofinferiorquality.87.有下列情形之一的藥品按劣藥論處：Adrugfallingintothefollowingcategoriesshallbedeemedasa

50、drugofinferiorquality:,一,未標明有效期或者更改有效期的,Thedateofexpiryisnotindicatedorisaltered;,二,不注明或者更改生產批號的,Thebatchnumberisnotindicatedorisaltered;,三,超過有效期的,Itisbeyondthedateofexpiry;,四,直接接觸藥品的包裝材料和容器未經批準的,12Noapprovalcertificateisobtainedfortheimmediatepackagingmaterialorcontainer;,五,擅自添加著色劑、防腐劑、香料、矯味劑及輔料的,C

51、olorants,preservatives,spices,flavorings,orotherrecipientshavebeenaddedwithoutauthorization;or,六,其他不符合藥品標準規(guī)定的。Othercaseswherethedrugstandardsarenotcompliedwith.88 .列入國家藥品標準的藥品名稱為藥品通用名稱。已經作為藥品通用名稱的該名稱不得作為藥品商標使用。AdrugnamelistedintheNationalDrugStandardsisanadoptednameinChina.Suchanadoptednameisnotperm

52、ittedtobeusedasatrademark.89 .藥品生產企業(yè)、藥品經營企業(yè)和醫(yī)療機構直接接觸藥品的工作人員必須每年進行健康檢查。Staffmembersofdrugmanufacturers,drugdistributorsandmedicalinstitutionswhomakeadirectcontactwithdrugsshallreceivephysicalexaminationannually.90 .患有傳染病或者其他可能污染藥品的疾病的不得從事直接接觸藥品的工作。Thosewhosufferfrominfectiousdiseasesoranyotherdisease

53、sthatmaycausedrugcontaminationarenotpermittedtoundertakeanyjobindirectcontactwithdrugs.91 .直接接觸藥品的包裝材料和容器必須符合藥用要求符合保障人體健康、安全的標準并由藥品監(jiān)督管理部門在審批藥品時一并審批。Immediatepackagingmaterialsandcontainersshallmeettherequirementsformedicinaluseandcomplywiththestandardsforensuringhumanhealthandsafety.Theyalongwiththe

54、drugsshallbesubjecttoreviewingandapprovalbythedrugregulatoryagency.92 .藥品包裝必須按照規(guī)定印有或者貼有標簽并附有說明書。Alabelshallbeprintedorstuckonthedrugpackagewithaninsertsheetattachedasrequiredbyregulations.93 .標簽或者說明書上必須注明藥品的通用名稱、成份、規(guī)格、生產企業(yè)、批準文號、產品批號、生產日期、有效期、適應癥或者功能主治、用法、用量、禁忌、不良反應和注意事項。Inthelabelorinsertsheetshallb

55、eindicatedtheadoptednameofthedrug,its13ingredients,strength,manufacturer,approvalnumber,productbatchnumber,productiondate,dateofexpiry,indicationsorfunctions,usage,dosage,contraindications,drugadversereactions,andprecautions.94 .麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標簽必須印有規(guī)定的標志。Specifiedmarksshallbeprin

56、tedinthelabelofnarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluse,radioactivepharmaceuticals,drugsfortopicaluse,andnon-prescriptiondrugs.95 .藥品的生產企業(yè)、經營企業(yè)和醫(yī)療機構必須執(zhí)行政府定價、政府指導價不得以任何形式擅自提高價格。Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallcomplywiththepricesfixedorguidedbythegovern

57、ment.Nooneispermittedtoraisepricesinanymannerwithoutauthorization.96 .禁止藥品的生產企業(yè)、經營企業(yè)和醫(yī)療機構在藥品購銷中帳外暗中給予、收受回扣或者其他利益。Drugmanufacturers,drugdistributorsandmedicalinstitutionsareprohibitedfromsecretofferingoracceptingrake-offsorotherbenefits(notshownintheaccountbook)inthecourseofpurchasingandsellingdrugs.97 .禁止藥品的生產企業(yè)、經營企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機構的負責人、藥品采購人員、醫(yī)師等有關人員以財物或者其他利益。Drugmanufacturers,drugdistributorsortheiragentsareprohibitedfromoffering,underanypretence,moneyorgoodsofvalueorotherbenefitstoleadingpeople,drugpur