中華人民共和國藥品管理法實施條例-試題

1、the problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimpr ovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sultsmor etointole d of decisi onvi sion,more to i n nati onalsome ha s effect

2、ofnewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submitted tobe pr agmati c. Quicka ndtimel y.The ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Therefore,thesubm ssion ofinformation to do "four",that is,findthe

3、 problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedba ck toimplementquickl y.Tobetr ue and accurate.True mainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracy isprimarily qualitativea nd qua ntitativeque stions,quantitativeobje ctiveofpu

4、bli cQualitative logi c.To be reliablea nd useful.Wesubmit inform ation to haveaccesst o de cisi on -making, to g uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalati on instrict a ccorda nce withthe procedures,firm,

5、newspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervisio nand insist on,ar ound a nd pr otecting theiri nterests to touchthe tr uth, see k practicalre sults.Adhere to people -orie nted,themostimportant thing is to re alize, safeguard a nd developthef undamen

6、talintere sts ofthe overwhelming majorityofthe people.Wecarry out inspe ction,so must go dee pamongt he masses,go dee p intot he realitie s,always payattention to the people's livel ihood,tograsp t he publ ic sentiment,a nd e arnestly safeguardt he be nefit,addressi ng themasses arem ostconcerne

7、 d about a nd refle ctingthe stronge st issues,effortsto solve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti onis oneofthemost importantpowersofthe Office,should not only dare to use, but alsowith cauti on. So-calle ddared to use, i stoho

8、lda numberofimportant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame does not hold did notmiss, dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority, with the benefits.Callwit h ca uti on, is supervisi ng de partmen

9、ts shouldstre ngthe n the consciousne ssofaut horizedstrictlya ccordi ng toproce dure, preventi ng thesupervi sion andexcessiveto preventadding burde n to grass -roots.Tothi s end, the supervisi on De partmentofthe Party Committeeofsupervision mustbeunder cityandCountypartyCommitteeSecretary-General

10、(Office).Second,weshould focuson.Isthe Governor, those relate dtothe gl obalEve nt,Gover northe protra cted diff icult,strong Gover nor duri ngemergency urgent. Not havi ng special departments in charge ofthe Ge neralGover nor,undert he n ormal proce dure can do g ood thing s not Governor, not a uth

11、orized by Countylea ders, notthe Gover nor. Third i s tosolve中華人民共和國藥品管理法實施條例（共45 題）（一）單項選擇題1. 藥品生產(chǎn)許可證有效期為（）。（D）A.1年B.2 年 C.3 年 D. 5年2. 藥品生產(chǎn)企業(yè)終止生產(chǎn)藥品或者關閉的，藥品生產(chǎn)許可證由（B ）部門繳銷。（ B ）A. 國務院藥品監(jiān)督管理B. 原發(fā)證C. 上級藥品監(jiān)督管理D. 企業(yè)所在地藥品監(jiān)督管理3. 生產(chǎn)有試行期標準的藥品，應當按照國務院藥品監(jiān)督管理部門的規(guī)定，在試行期滿前（），提出轉正申請。（A）A.3 個月B.6 個月C.9 個月 D.12 個月4.

12、 藥品生產(chǎn)企業(yè)變更藥品生產(chǎn)許可證許可事項的，應當在許可事項發(fā)生變更（ ） 前，向原發(fā)證機關申請藥品生產(chǎn)許可證變更登記；未經(jīng)批準，不得變更許可事項。（D ）A.7 日 B.15日 C.20 日 D.30 日5. 經(jīng)營處方藥、（）非處方藥的藥品零售企業(yè)，應當配備執(zhí)業(yè)藥師或者其他依法經(jīng)資格認定的藥學技術人員。（A）A. 甲類 B. 乙類 C. 甲、乙兩類D./6. 生產(chǎn)中藥飲片，應當選用與藥品性質（）的包裝材料和容器；包裝不符合規(guī)定的中藥飲片不得銷售。中藥飲片包裝必須印有或者貼有標簽。（B ）A. 相同 B. 相適應C. 相關 D. 沒有禁忌7. 國家實行處方藥和非處方藥分類管理制度。國家根據(jù)非處方

13、藥品的（）性，將非處方藥分為甲類非處方藥和乙類非處方藥。（B ）A. 有效 B. 安全 C. 確切 D. 可及8. 藥品流通許可證有效期為（）。（D）A.1年B.2 年 C.3 年 D. 5年9. 新藥，是指（ ） 的藥品。（B ）A. 首次生產(chǎn)銷售B. 未曾在中國境內上市銷售C. 首次生產(chǎn)銷售或首次進口D. 未曾在中國境內出現(xiàn)10. 藥品監(jiān)督管理部門撤銷藥品廣告批準文號后，應當自做出行政處理決定之日起（ ）工作日內通知廣告監(jiān)督管理機關。（B ）A.3 個 B.5 個 C.7 個 D.10 個11. 生產(chǎn)注射劑、（） 和國務院藥品監(jiān)督管理部門規(guī)定的生物制品的藥品生產(chǎn)企業(yè)的he Office o

14、fpartyo there ception,alittle moreity ofmessage humanc - - 一 I .-II.ethe quality. II I 1.1I 一 一.L. Ill. .11. - I - . 一 一 J - .一 , I 一一 一 一I. _ . , _ I _>.11_ L . -.I L 一 I -I ncepriva cy manageme nt standar dization, modernizationofsecurityte chniquesa sa mea ns ofa dministrationaccor - . _L. 一-d

15、ing t olawa nd security.L . I -一 - -eelings survey,by looki ng uppubli cse ntiments tofindpr obl ems. Pr oblems will increase its special supervisi on, set up accounts,settlesrateof100%.Haveanimnating i nternalandexter nalfeatures,contact, rallyatalllevels,to motivateeveryaspect,adhere to thetruth,s

16、trengt heni ng standardized management to achieve coherent, efficient andeffectivefunctioningofthe dailywork ofthe PartyCommittee.Iss,reduci ng procedures, improve messag eha ndli ng efficiency. S pecifications,is to strictly enforcethe ba n issued by theCommunipartydocume nts or derly. Highqualit y

17、, ist o improve thequality ofprocessi ng, itis necessary to accuratelyimplementingthe i ntention of the PartyCommittee,clearance, goodcommunications,policy pr ogramclosed, ensuring that t here is no error.Second meetingscheduledtoensure thoroug h,safe a nd efficie nt.Any arrangements for themeetings

18、a ndeve nts,carefully arranged, itemnted, sure. o vigor ouslystreamlinemeetings,a ctivities, number ofpressurereduction, scalet oensure that leadership emer gedfrom theGe neral Conference andentertainmentservices,focus on bigthings,matters.Third,re cepti on serviceshould lay stress on humaenforceme

19、nt, ensurethe san.Reception and work directly with people, re cepti on services directlyaffecting tfidentialworkto meetthe demands of newtechnology develo pment-IL.huma n needs,a littlemorehumaneatmosphere,and constantly improvethe service, improvofservi ce.M eanw hile,t ofurtherpayspecialattention

20、tohe daily w orkofthe other Office System.Confidentialwork re sponsibilitysy stem for leadi ng ca dresto implementsecurity as aleade r,to improvet heconfidentialityofclassified personnel,especi ally leadi ng ca dres, strengthening party a ndGovernment focus on vital sect ors ofsecurity management,to

21、advaancare morethe problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimprovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemasterpie ce, makesweofresearch re sultsmor etointole d of decisi onvi sion,more to in nationalsome h

22、a s effectofnewspaperShangpublished,fora dvance work, and publicitychangde play dueofrole.Third,information submittedto be pragmati c. Quicka ndtimel y.The ancients said:forthe timesystem;statement backforthe time being, nothi ng.Therefore,thesubmi ssion ofinformation todo "four",that is,f

23、indthe problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedback toimplementquickl y.Tobetr ueand accurate.Truemainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracyis primarily qualitative a nd qua ntitativeque stions,quantitative obje ctiv

24、eofpublicQualitative logic.To be reliablea nd useful.Wesubmit inform ation to haveaccesst o de cision-making,to g uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalation instrict a ccorda nce withthe procedures,firm,n

25、ewspaper, ne wspa pers, neverlate,failto report,false claim and skimmi ng.Investe e2.supervision andinsiston, around a nd pr otecting theiri nterests to touchthe tr uth, see k practicalre sults.Adhere to people -orie nted,themostimportant thing is to re alize, safeguard a nd developthef undamentalin

26、terests ofthe overwhelming majorityofthe people.Wecarry out inspe ction,so must go dee pamongthe masses,godee p intot he realitie s,always payattention to thepeople's livel ihood,tograsp t he publ ic sentiment,a nd e arnestly safeguardthe benefit,addressi ng themasses arem ostconcerne d about an

27、d reflectingthe strongest issues,effortstosolve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti on isoneofthemost important powersofthe Office,shouldnot only dare to use,but alsowith cauti on.So -calle ddared to use, i stoholda numberofimpo

28、rtant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame doesnot holddid notmiss,dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority,with thebenefits. Callwit h caution, is supervising departments shouldstrengthen the

29、consci ousne ssofaut horizedstrictlya ccordi ng toproce dure, preventing thesupervision andexcessiveto preventadding burden to grass -roots.Tothi s end, the supervisi on De partmentoftheParty Committeeofsupervision mustbeunder cityandCountypartyCommittee Secretary-General（Office）.Second,we should fo

30、cuson. Isthe Governor, those relatedtothe gl obalEve nt,Gover northe protracted difficult,strong Gover nor duri ngemergency urgent.Not havi ng specialdepartments in charge ofthe Ge neralGover nor,undert he normalprocedure can do g ood things not Governor,not uthorized by Countylea ders, notthe Gover

31、 nor. Third i s tosolve藥品生產(chǎn)質量管理規(guī)范認證工作，由國務院藥品監(jiān)督管理部門負責。（A）A. 放射性藥品B. 疫苗 C. 急救藥品D. 毒麻藥品12. 依法實行政府定價、政府指導價的藥品，制定和調整藥品銷售價格時，應當體現(xiàn)對藥品（）的控制。（D）A. 社會平均銷售費用率B. 社會平均銷售費用率、銷售利潤率C. 銷售利潤率和流通差率D. 社會平均銷售費用率、銷售利潤率和流通13. 國務院藥品監(jiān)督管理部門對已批準生產(chǎn)、銷售的藥品進行再評價，根據(jù)藥品再評價結果，可以采取責令（）的措施。（C ）A. 修改說明書B. 停止使用C. 修改說明書，暫停生產(chǎn)、銷售和使用D. 召回已上市

32、藥品14. 國務院藥品監(jiān)督管理部門根據(jù)保護公眾健康的要求，可以對藥品生產(chǎn)企業(yè)生產(chǎn)的新藥品種設立不超過（）的監(jiān)測期。（B）A.3 年 B.5 年 C.8 年 D.10 年15. 醫(yī)療機構制劑許可證有效期為（）。（D）A.1年B.2 年 C.3 年 D. 5年16. 醫(yī)療機構終止配制制劑或者關閉的，醫(yī)療機構制劑許可證由原發(fā)證機關（）。（D）A. 注銷 B. 吊銷 C. 收回 D. 繳銷（二）多項選擇題2. 關于藥品檢驗費用的規(guī)定，正確的有（）。（ABC）A. 藥品抽查檢驗，不得收取任何費用；B. 當事人對藥品檢驗結果有異議，申請復驗的，應當向復驗機構預先支付藥品檢驗費用；C. 復驗結論與原檢驗結論

33、不一致的，復驗檢驗費用由原藥品檢驗機構承擔；D.復驗結論與原檢驗結論不一致的，復驗檢驗費用由原藥品抽查檢驗機構承擔。3. 下列事實政府定價或政府指導價的藥品有（）。（AB）A. 列入國家基本醫(yī)療保險藥品目錄的藥品B. 具有壟斷性生產(chǎn)、經(jīng)營的藥品；C. 處方藥；D. 嬰幼兒藥品。4. 違反 藥品管理法及其實施條例的規(guī)定屬于從重處罰情節(jié)的有（）。 （ ABCD）A. 生產(chǎn)、銷售以孕產(chǎn)婦、嬰幼兒及兒童為主要使用對象的假藥、劣藥的；B. 生產(chǎn)、銷售的生物制品、血液制品屬于假藥、劣藥的；C. 生產(chǎn)、銷售、使用假藥、劣藥，經(jīng)處理后重犯的；an.Recepti fide>. L 一一一. 一 - -.

34、 II-e sin dhandling reg .- - 一.- .-IL. - 一 I _. . 一 |_ethe quality. II . 一 一I 一 一.L. Ill. .11. - I - . 一 一 J - .一 , I 一一 一 一I. _ . , _ I _>.11_ L . -.I L 一 I -I adership emer gedfrom theGesettlesrateof100%.Haveanimpactonsomeoftheoutsta ndi ng issues, supervisi ondepartment s and information compo

35、nentnating i nternalandexter nalfeatures,contact, rallyatalllevels,to motivateeveryaspect,adhere to th,strengt heni ng standardized management to achieve coherent, efficient andeffectivefunctioningofthe dailywork ofthe PartyCommittee.Iss,reduci ng procedures, improve messag eha ndli ng efficiency. S

36、 pecifications,is to strictly enforcethe ba n issued by theCommunist party aut horitiein documentulations a nd pr ovincialand municipal regulations, conscienti ouslystrengthen and impr ove communications manageme nttoensurethatpartydocume nts or derly. High qualit y, ist o improve thequality ofmessa

37、geprocessi ng, itis necessary to a cc urately implementingthe i ntention of the PartyCommittee,clearance,goodcommunications,policy pr ogramclosed, ensuring thatt here is no error.Second meetingscheduledtoensure thoroug h,safe a nd efficie nt.Any arrangements for themeetingsa ndeve nts,carefully arra

38、nged, itemnted, sure. o vigor ouslystreamlinemeetings,a ctivities, number ofpressurereduction, scalet oensure that leneral Conference andentertainmentservices,focus on bigthings,matters.Third,re cepti on serviceshould lay stress on humaenforceme nt, ensurethe saon and work directly with people, re c

39、epti on services directlyaffecting tntialworkto meetthe demands of newtechnology develo pmenthe Office ofparty CommitteeThe imageoftheregion.At the sametimestrengthe ning theconstructin of library, improve the re cepti on conditi ons, more human -ori ented, personal,culturalw ork into there ception,

40、alittle morehuma n needs,a littlemorehumancare morehumaneatmosphere,and constantly improvethe service, improvofservi ce.M eanw hile,t ofurtherpayspecialattention tohe daily w orkofthe other Office System.Confidentialwork re sponsibilitysy stem for leadi ng ca dresto implementsecurity as aleade r,toi

41、mprovet heconfidentialityofclassified personnel,especi ally leadi ng ca dres, strengthening party a ndGovernment focus on vital sect ors ofsecurity management,toadvanceprivacy management standar dization, modernizationofsecuritytechniquesa sa mea ns ofa dministrationaccor- I - -一J ding t olawa nd se

42、curitythe problem.The pur poseofsupervi sion,toresolve theproblem. To a dher e toand furtherimpr ovetheout city created,a ndcaremasses life,focuswork,i n-dept hinvestigation,moreout bouti quemaster pie ce, makesweofrese arch re sultsmor etointole d of decisi onvi sion,more to i n nati onalsome ha s

43、effectofnewspaperShangpublished,fora dvance work, and publicity changde play dueofrole.Third,information submitted tobe pragmati c. Quicka ndtimel y.The ancients said:forthe timesystem;statement backfort he time bei ng, nothi ng.Therefore,thesubmi ssion ofinformation to do "four",that is,f

44、indthe problemfaster,editorialwriting,se nd and rea dfaster appr ovaland feedba ck to implementquickl y.Tobetr ue and accurate.True mainlyreflect thefull picture ofevents,oneis one ,two,thi s isthe life oftheinformation.Accuracy isprimarily qualitativea nd qua ntitativeque stions,quantitativeobje ct

45、iveofpubli cQualitative logi c.To be reliablea nd useful.Wesubmit inform ation to haveaccesst o de cisi on -making, to g uide and promote t he work a nd solve practica lproblems. Mixedcum.Onthe negative informationa nd emerge ncyi nformation,ra pide scalati on instrict a ccorda nce withthe procedure

46、s,firm,newspaper, ne wspa pers, neverlate,failto re port,false claim a nd skimmi ng.Investe e2.supervision andinsiston, around a nd pr otecting theiri nterests to touchthe tr uth, see k practicalre sults.Adhere to people -orie nted,themostimportant thing is to re alize, safeguard a nd developthef un

47、damentalintere sts ofthe overwhelming majorityofthe people.Wecarry out inspe ction,so must go dee pamongt he masses,go dee p intot he realitie s,always payattention to the people's livel ihood ,to graspt he publ ic sentiment,a nd e arnestly safeguardt he be nefit,addressi ng themasses arem ostco

48、ncerne d about a nd refle ctingthe stronge st issues,effortsto solve t hepr oblem ofdeci sionsimpl emented a nd not implemented. One istostick to principl es. Rightof i nspecti onis oneofthemost importantpowersofthe Office,should not only dare to use, but alsowith cauti on.So-calle ddared to use, i

49、stoholda numberofimportant issue s, bold supervisi on ov ersupervisi on,tra ckinspe ction, problemsare notsolved do not pass,the blame does not hold did notmiss, dissatisfaction ofthemasses did notmiss,the realrightofsupervision authority, with the benefits.Callwit h ca ution, is supervisi ng de par

50、tments shouldstrengthen the consci ousne ssofaut horizedstrictlya ccordi ng toproce dure, preventi ng thesupervi sion andexcessiveto preventadding burde n to grass -roots.Tothi s end, the supervisi on De partmentofthe Party Committeeofsupervision mustbeunder cityandCountypartyCommittee Secretary-Gen

51、eral(Office).Second,weshould focuson.Isthe Governor, those relate dtothe gl obalEve nt,Gover northe protra cted diff icult,strong Gover nor duri ngemergency urgent. Not havi ng special departments in charge ofthe Ge neralGover nor,undert he normalproce dure can do g ood thing s not Governor, not a u

52、thorized by Countylea ders, notthe Gover nor. Third i s tosolveD.拒絕、逃避監(jiān)督檢查，或者偽造、銷毀、隱匿有關證據(jù)材料的，或者擅自動用 查封、扣押物品的。5. 藥品監(jiān)督管理部門設置的派出機構，有權作出的行政處罰包括（）。（ABD）A. 警告 B. 罰款 C. 吊銷許可證D.沒收違法生產(chǎn)、銷售的藥品和違法所得6. 藥品合格證明和其他標識包括（）。（ABCD）A. 藥品生產(chǎn)批準證明文件B. 藥品檢驗報告書C. 藥品的包裝、標簽D. 藥品的說明書 6. 非處方藥的特點是（）。（ABD）A. 由國務院藥品監(jiān)督管理部門公布；B. 不需要憑執(zhí)

53、業(yè)醫(yī)師和執(zhí)業(yè)助理醫(yī)師處方購買；C. 需要憑執(zhí)業(yè)醫(yī)師和執(zhí)業(yè)助理醫(yī)師處方購買；D.消費者可以自行判斷、購買和使用。7. 醫(yī)療機構制劑的特點包括（）。（ABCD）A. 醫(yī)療機構根據(jù)本單位臨床需要的B. 須經(jīng)批準方可配置配制；C. 只能用于醫(yī)療機構自用；D. 其處方是固定的。8. 藥品批發(fā)企業(yè)的銷售對象包括（）。（ABC）A. 藥品生產(chǎn)企業(yè)B. 藥品經(jīng)營企業(yè)C. 醫(yī)療機構D. 消費者9. 依法進行的（）等可以收取費用。（ABCD）A. 核發(fā)證書B. 進行藥品注冊、藥品認證C. 實施藥品審批檢驗D. 強制性檢驗 10. 下列哪些藥品廣告必須立即停止發(fā)布？（ABC）A. 未經(jīng)省、自治區(qū)、直轄市人民政府藥品

54、監(jiān)督管理部門批準的藥品廣告；B. 使用偽造、冒用、失效的藥品廣告批準文號的廣告；C. 因其他廣告違法活動被撤銷藥品廣告批準文號的廣告；D.有患者投訴舉報的藥品廣告。11. 下列哪些情況應向藥品監(jiān)督管理部門申請藥品生產(chǎn)質量管理規(guī)范認證？（ ABC）A. 新開辦藥品生產(chǎn)企業(yè)B. 藥品生產(chǎn)企業(yè)新建藥品生產(chǎn)車間C. 藥品生產(chǎn)企業(yè)新增生產(chǎn)劑型D. 醫(yī)療機構研發(fā)新藥12. 不得委托生產(chǎn)的藥品包括（）。（ABC）A. 疫苗 B. 血液制品C. 國務院藥品監(jiān)督管理部門規(guī)定的其他藥品D. 乙類藥,then settlesrateof10of100%.H%.Haveanimpactonsomeoftheoutst

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