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(chǎn)企業(yè)管理controloverdrugmanufacturers3. 藥品經(jīng)營企業(yè)管理controloverdrugdistributors4. 醫(yī)療機構(gòu)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(zé)任legalliabilities10. 藥品標(biāo)識labelsormarksofthedrugs11. 假藥counterfeitdrugs112. 劣藥inferiordrugs13. 藥品檢驗機構(gòu)drugqualitycontrollaboratory14. 藥品的生產(chǎn)企業(yè)drugmanufacturers15. 經(jīng)營企業(yè)drugdistributors16. 醫(yī)療機構(gòu)medicalinstitutions17. 藥品監(jiān)督管理部門drugregul

3、atoryagency18. 藥品批準(zhǔn)證明文件drugapprovaldocuments19. 行政處分administrativesanctions20. 刑事責(zé)任criminalliabilities21. 藥品生產(chǎn)質(zhì)量管理規(guī)范GoodManufacturingPracticeforPharmaceuticalProducts(GMP)22. 藥品經(jīng)營質(zhì)量管理規(guī)范GoodSupplyPracticeforPharmaceuticalProducts(GSP)23. 藥品生產(chǎn)許可證DrugManufacturingCertificate224. 藥品經(jīng)營許可證DrugSupplyCertif

4、icate25. 醫(yī)療機構(gòu)制劑許可證PharmaceuticalPreparationCertificateforMedicalInstitution26. 進(jìn)口藥品注冊證書ImportDrugLicense27. 臨床試驗clinicaltrial28. 新藥證書NewDrugCertificate29. 藥品批準(zhǔn)文號DrugApprovalNumber30. 在中華人民共和國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)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(wù)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(fù)責(zé)本

6、行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。Thedrugregulatoryagenciesofthegovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.33. 藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗機構(gòu)承擔(dān)依法實施藥品審批和藥品質(zhì)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(chǎn)企業(yè)須經(jīng)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(zhǔn)并發(fā)給藥品生產(chǎn)許可證憑藥品生產(chǎn)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(chǎn)許可證應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)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(zhǔn)開辦藥品生產(chǎn)企業(yè)應(yīng)當(dāng)符合國家制定的藥品行業(yè)36.發(fā)展規(guī)劃和產(chǎn)業(yè)政策防止重復(fù)建設(shè)。Whengivingapprovaltothenewly-establishedmanufacturer,thedrugregulatoryagenc

10、yshallseetoitthatthedevelopmentprogramsandpoliciessetbytheStateforthepharmaceuticalindustryshallbecompliedwithsoastopreventduplicateconstruction.37 .開辦藥品生產(chǎn)企業(yè)必須具備以下條件：，一，具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人,二,具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境,三,具有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗的機構(gòu)、人員以及必要的儀器設(shè)備,四,具有保證藥品質(zhì)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(chǎn)企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的藥品生產(chǎn)質(zhì)量管理規(guī)范組織生產(chǎn)。藥品監(jiān)督管理部門按照規(guī)定對藥品生產(chǎn)企業(yè)是否符合藥品生產(chǎn)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)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(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的

14、生產(chǎn)工藝進(jìn)行生產(chǎn)生產(chǎn)記錄必須完整準(zhǔn)確。WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatoryagencyoftheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.40 .藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的必

15、須報原批準(zhǔn)部門審核批準(zhǔn)。Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthechangetotheoriginalauthorityforreviewingandapproval.41 .生產(chǎn)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(chǎn)企業(yè)必須對其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗。Drugmanufacturersshallperformqualitytestoftheirproducts.43 .不符合國家藥品標(biāo)準(zhǔn)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(jīng)國務(wù)院藥品監(jiān)督管理部門或者國務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。Adrugmanufacturermaynotacceptanycontractproductionofdrugsunlessitis5approvedbythedrugre

18、gulatoryagencyoftheStateCouncil,orbythedrugregulatoryagencyofthegovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatoryagencyoftheStateCouncil.45 .開辦藥品批發(fā)企業(yè)須經(jīng)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(zhǔn)并發(fā)給藥品經(jīng)營許可證.Anynewlyestablisheddrugwholesalershallbesubj

19、ecttoapprovalofthelocaldrugagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate.46 .開辦藥品零售企業(yè)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。Anynewlyestablisheddrugretailershallbesubjecttoapprovalandbegrantedtheabovecertificatebythel

20、ocaldrugregulatoryagencyatorabovethecountylevel.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。WiththeDrugSupplyCertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativeagencyforindustryandcommerce.47 .無藥品經(jīng)營許可證的不得經(jīng)營藥品。Nooneispermittedtodistributedrugswithoutthecertificate.48 .藥品經(jīng)營許可證應(yīng)當(dāng)標(biāo)明有效

21、期和經(jīng)營范圍到期重新審查發(fā)證。ThevalidperiodandthescopeofbusinessshallbeindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.49 .開辦藥品經(jīng)營企業(yè)必須具備以下條件:,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。Adrugdistrib

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

23、d(4)establishingrulesandregulationstogovernthequalityofthedrugstobedistributed.650 .藥品經(jīng)營企業(yè)必須按照國務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的藥品經(jīng)營質(zhì)量管理規(guī)范經(jīng)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(jīng)營企業(yè)是否符合藥品經(jīng)營質(zhì)量管理51.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。ThedrugregulatoryagencyinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.52 .藥品經(jīng)營企業(yè)購進(jìn)藥品必須建立并執(zhí)行進(jìn)貨檢查驗收制度驗明藥品合格證明和其他標(biāo)識，不符合規(guī)定要求的不得購進(jìn)。Afterreceivingthedrugpurchased,drugdistributorsshallpassthe

25、establishedexaminationandacceptancesystem,andcheckthecertificateofdrugquality,labelsandothersmarks;nodrugsthatfailtomeettherequirementsarepermittedtobepurchased.53 .藥品經(jīng)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(chǎn)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(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。Intherecordshallbeindicatedtheadoptednameofdrugs,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchaser(orseller),amountofthedrugpurchased(orsold),purchaseorsellingprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulato

27、ryagencyoftheStateCouncil.55 .藥品經(jīng)營企業(yè)銷售中藥材必須標(biāo)明產(chǎn)地。DrugdistributorsshallindicatethehabitatofChinesecrudedrugstobesold.56 .藥品經(jīng)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(zhì)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(mào)易市場可以出售中藥材國務(wù)院另有規(guī)定的除外。Chinesecrudedrugsmaybesoldatfairsinurbanandruralareas,exceptthoseotherwisespecifiedbytheStateCounci

29、l.59 .城鄉(xiāng)集市貿(mào)易市場不得出售中藥材以外的藥品但持有藥品經(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)點出售中藥材以外的藥品。NodrugsotherthantheChinesecrudedrugsmaybesoldatfairsinurbanandruralareas,butdrugretailersholdingtheDrugSupplyCertificatemay,withinthespecifiedbusinessscope,sellsuchdrugsatthestorestheysetupatthefairs.60 .醫(yī)療機構(gòu)配制制劑須經(jīng)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(zhǔn)發(fā)給醫(yī)療機構(gòu)制劑許可證。Dispensingpharmaceuticalpreparationsbyamedicalinstitutionshallbesubjecttoreviewingandpermissionbythehealthadministrationagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,anduponapprovalbythedrugregulat

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

32、證應(yīng)當(dāng)標(biāo)明有效期到期重新審查發(fā)證。ThetermofvalidationshallbenotedinthePharmaceuticalPreparationCertificateforMedicalInstitution.Forrenewalofthecertificateuponexpiration,reviewingandapprovalagainisrequired.63 .醫(yī)療機構(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。Thepharmaceuticalpreparationstobedispensedb

33、ythemedicalinstitutionshallbe8thosesatisfyingtheclinicneedoftheinstitutionbutnotavailableonthemarket.Itshallbesubjecttoapprovalinadvancebythelocaldrugregulatoryagencyofthegovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.64 .醫(yī)療機構(gòu)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(wù)院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗結(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。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(wù)院藥品監(jiān)督管理部門批準(zhǔn)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(gòu)和臨床試驗機構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)范。Theinstitutionsfornon-clinicalsafetyevaluationandstudyandforclinicalstudyinstitutionsshallrespectivelyfollowtheGoodLaboratoryPracticeforNon-ClinicalLaboratoryStudies(GLP)andGoodClinicalP

37、ractice(GCP).68. 生產(chǎn)新藥或者已有國家標(biāo)準(zhǔn)的藥品的須經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給藥品批準(zhǔn)文號，但是生產(chǎn)沒有實施批準(zhǔn)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(zhǔn)文號管理的中藥材、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理部9門會同國務(wù)院中醫(yī)藥管理部門制定。ThelistoftheChinesecrudedrugsandthepreparedslicesoftheChinesecrudedrugstobecontrolledbytheapprovalnumbershallbecompiledbythedrugregulatoryagencyoftheStateCoun

39、cil,jointlywiththeadministrativeagencyfortraditionalChinesemedicinesoftheStateCouncil.70. 藥品生產(chǎn)企業(yè)在取得藥品批準(zhǔn)文號后方可生產(chǎn)該藥品。Adrugmanufacturerispermittedtoproducethedrugonlyafteranapprovalnumberhasbeengrantedtoit.71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。DrugsshallcomplywiththeNationalDrugStandards.72. 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

40、品標(biāo)準(zhǔn)。ThePharmacopoeiaofthePeople'sRepublicofChinaandtheDrugStandardsissuedbythedrugregulatoryagencyoftheStateCouncilshallserveastheNationalDrugStandards.73. 國務(wù)院藥品監(jiān)督管理部門組織藥典委員會負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂。ThedrugregulatoryagencyoftheStateCouncilshallorganizeapharmacopoeiacommission,whichshallberesponsibleforfor

41、mulatingandrevisingtheNationalDrugStandards.74. 國務(wù)院藥品監(jiān)督管理部門的藥品檢驗機構(gòu)負(fù)責(zé)標(biāo)定國家藥品標(biāo)準(zhǔn)品、對照品。ThedrugcontrolinstitutionaffiliatedtothedrugregulatoryagencyoftheStateCouncilisresponsibleforstandardizingtheNationalDrugStandardSubstanceandReferenceSubstance.75. 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機構(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)沒有實施批準(zhǔn)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(hù)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(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。ReviewingthedrugstobeimportedshallcomeofthejurisdictionofthedrugregulatoryagencyoftheStateCouncil.Adrugispermittedtobeimportedonlyuponapprovalgrantedafterconfirmingthatitconformstothequality,safelyandefficiencythroughexamination,andadrugimpor

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

46、2. 禁止生產(chǎn),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(biāo)準(zhǔn)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(wù)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(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口或者依照本法必須檢驗

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

49、ationsorfunctionsindicatedarebeyondthespecifiedscope.85 .禁止生產(chǎn)、銷售劣藥。Productionanddistributionofdrugsofinferiorqualityareprohibited.86 .藥品成份的含量不符合國家藥品標(biāo)準(zhǔn)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(biāo)明有效期或者更改有效期的,Thedateofexpiryisnotindicatedorisaltered;,二,不注明或者更改生產(chǎn)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(jīng)批準(zhǔn)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(biāo)準(zhǔn)規(guī)定的。Othercaseswherethedrugstandardsarenotcompliedwith.88 .列入國家藥品標(biāo)準(zhǔn)的藥品名稱為藥品通用名稱。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。AdrugnamelistedintheNationalDrugStandardsisanadoptednameinChina.Suchanadoptednameisnotperm

52、ittedtobeusedasatrademark.89 .藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)和醫(yī)療機構(gòu)直接接觸藥品的工作人員必須每年進(jìn)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(biāo)準(zhǔn)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(biāo)簽并附有說明書。Alabelshallbeprintedorstuckonthedrugpackagewithaninsertsheetattachedasrequiredbyregulations.93 .標(biāo)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(chǎn)企業(yè)、批準(zhǔn)文號、產(chǎn)品批號、生產(chǎn)日期、有效期、適應(yīng)癥或者功能主治、用法、用量、禁忌、不良反應(yīng)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(biāo)簽必須印有規(guī)定的標(biāo)志。Specifiedmarksshallbeprin

56、tedinthelabelofnarcoticdrugs,psychotropicsubstances,toxicdrugsformedicaluse,radioactivepharmaceuticals,drugsfortopicaluse,andnon-prescriptiondrugs.95 .藥品的生產(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機構(gòu)必須執(zhí)行政府定價、政府指導(dǎo)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(chǎn)企業(yè)、經(jīng)營企業(yè)和醫(yī)療機構(gòu)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(chǎn)企業(yè)、經(jīng)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(gòu)的負(fù)責(zé)人、藥品采購人員、醫(yī)師等有關(guān)人員以財物或者其他利益。Drugmanufacturers,drugdistributorsortheiragentsareprohibitedfromoffering,underanypretence,moneyorgoodsofvalueorotherbenefitstoleadingpeople,drugpur