DRUG ADMINISTRATION LAW OF THE PEOPLES REPUBLIC OF CHINA.docx
- 文档编号:14248625
- 上传时间:2023-06-21
- 格式:DOCX
- 页数:24
- 大小:26.32KB
DRUG ADMINISTRATION LAW OF THE PEOPLES REPUBLIC OF CHINA.docx
《DRUG ADMINISTRATION LAW OF THE PEOPLES REPUBLIC OF CHINA.docx》由会员分享,可在线阅读,更多相关《DRUG ADMINISTRATION LAW OF THE PEOPLES REPUBLIC OF CHINA.docx(24页珍藏版)》请在冰点文库上搜索。
DRUGADMINISTRATIONLAWOFTHEPEOPLESREPUBLICOFCHINA
DRUGADMINISTRATIONLAWOFTHEPEOPLE’SREPUBLICOFCHINA
(Adoptedatthe7thMeetingoftheStandingCommitteeoftheSixthNationalPeople’sCongressonSeptember20,1984,revisedatthe20thMeetingoftheStandingCommitteeoftheNinthNationalPeople’sCongressonFebruary28,2001)
CONTENT
ChapterⅠGeneralProvisions
ChapterⅡControloverDrugManufacturers
ChapterⅢControloverDrugDistributors
ChapterⅣControloverPharmaceuticalsinMedicalInstitutions
ChapterⅤControloverDrugs
ChapterⅥControloverDrugPackaging
ChapterⅦControloverDrugPricingandAdvertising
ChapterⅧInspectionofDrugs
ChapterⅨLegalLiabilities
ChapterⅩSupplementaryProvisions
ChapterⅠ
GeneralProvisions
Article1 Thislawisenactedtostrengthendrugadministration,toensuredrugqualityandsafetyforhumanbeings,toprotectthehealthofpeopleandtheirlegitimaterightsandinterestsintheuseofdrugs.
Article2 Allinstitutionsandindividualsengagedinresearch,production,distribution,use,ordrugadministrationinthePeople’sRepublicofChinashallabidebythislaw.
Article3 Thestatedevelopsbothmodernandtraditionalmedicinestogivefullplaytotheirroleinpreventionandtreatmentofdiseasesandinmaintenanceofhealth.
ThestateprotectstheresourcesofnaturalcrudedrugsandencouragesthecultivationofChinesecrudedrugs.
Article4 Thestateencouragesresearchanddevelopmentofnewdrugsandprotectsthelegitimaterightsandinterestsofcitizens,legalbodiesandinstitutionsengagedinthisfieldofendeavor.
Article5 thedrugregulatorydepartmentundertheStatCouncilshallberesponsiblefordrugadministrationsnationwide.TherelevantdepartmentsundertheStateCouncilshallberesponsiblefortherelatedadministrativeworkwithinthelimitsoftheirduties.
Thedrugregulatoryofthepeople’sgovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.Therelevantdepartmentsofthesaidpeople’sgovernmentsshallberesponsiblefortherelatedregulatoryworkwithinthelimitsoftheirduties.
ThedrugregulatorydepartmentundertheStateCouncilshallcooperatewiththecompetentdepartmentsforcomprehensiveeconomicadministrationundertheStateCouncilinimplementingpharmaceuticaldevelopmentprogramsandpoliciesformulatedbytheStateforthepharmaceuticalindustry.
Article6 Thedrugtestinginstitutesestablishedordesignatedbydrugregulatorydepartmentsshallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualityinaccordancewithlaw.
ChapterⅡ
ControloverDrugManufacturers
Article7 Theestablishmentofsdrugmanufacturershallbesubjecttoapprovalbythelocaldrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativedepartmentforindustryandcommerce.Noonemaymanufacturedrugswithoutthecertificate.
ThevalidtermandthescopeofmanufacturingshallbeindicatedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reexaminationisrequired.
Whengivingapprovaltotheestablishmentofanewmanufacturer,thedrugregulatorydepartmentshallseetoitthat,apartfromtherequirementsspecifiedbytheprovisionsinArticle8ofthisLawthatshouldbemet,thepharmaceuticaldevelopmentprogramsandpoliciesformulatedbytheStateforthepharmaceuticalindustryareconformedtoandpreventduplicateconstruction.
Article8 Adrugmanufacturertotheestablishedshallmeetthefollowingrequirements:
(1) havinglegallyqualifiedpharmaceuticalandengineeringprofessionals,andthenecessarytechnicalworkers;
(2) havingthepremises,facilities,andhygienicenvironmentrequiredfordrugmanufacturing;
(3) havingtheinstitutionsandpersonnelcapableofqualitycontrolandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and
(4) havingrulesandregulationstoensurethequalityofdrugs.
Article9 DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeforPharmaceuticalProducts(GMP)formulatedbythedrugregulatorydepartmentundertheStateCouncilonthebasisofthisLaw.ThedrugregulatorydepartmentshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.
ThespecificmeasuresandscheduleforimplementingtheGMPshallbeformulatedbythedrugregulatorydepartmentundertheStateCouncil.
Article10 WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatorydepartmentundertheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthematterforexaminationandapprovaltotheoriginalapprovalauthority.
PreparedslicesofChinesecrudedrugsshallbeprocessedinconformitywiththenationaldrugstandards.Thosenotcoveredbythenationaldrugstandardsshallbeproducedaccordingtotheprocessingproceduresformulatedbythedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernment.ThesaidprocessingproceduresshallbesubmittedtothedrugregulatorydepartmentundertheStateCouncilfortherecord.
Article11 Thedrugsubstancesandexcipientsforthemanufactureofpharmaceuticalproductsshallmeettherequirementsformedicinaluse.
Article12 Drugmanufacturersshallperformqualitytestofthedrugproduced;nodrugthatdonotmeetthenationaldrugstandardsorthatarenotproducedaccordingtotheprocessingproceduresforthepreparedslicesofChinesecrudedrugsformulatedbythedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentmaybereleased.
Article13 AdrugmanufacturermayacceptcontractproductionofdrugsuponapprovalbythedrugregulatorydepartmentundertheStateCouncil,orbythedrugregulatorydepartmentofthepeople’sgovernmentofaprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentauthorizedbythedrugregulatorydepartmentundertheStateCouncil.
ChapterⅢ
ControloverDrugDistributors
Article14 Theestablishmentofadrugwholesalershallbesubjecttoapprovalofthelocaldrugregulatorydepartmentofthepeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugSupplyCertificate;theestablishmentofadrugretailershallbesubjecttoapprovalandbegrantedthesaidcertificatebythelocaldrugregulatorydepartmentatorabovethecountrylevel.Withthecertificate,thewholesalerandtheretailershallberegisteredwiththeadministrativedepartmentforindustryandcommerce.Noonemaydistributedrugswithoutthecertificate.
ThevalidtermandthescopeofbusinessshallbeindicatedintheDrugSupplyCertificate.Forrenewalofthecertificateuponexpiration,reexaminationisrequired.
Whengivingapprovaltotheestablishmentofanewdistributor,thedrugregulatorydepartmentshallseetoitthat,apartfromtherequirementsspecifiedbytheprovisionsinArticle15ofthisLawthatshouldbemet,theprinciplesofappropriatelocationandconvenientpurchaseofdrugsbythepeopleareadheredto.
Article15 Adrugdistributortobeestablishedshallmeetthefollowingrequirements:
(1) havinglegallyqualifiedpharmaceuticalprofessionals;
(2) havingthebusinessoperationpremises,equipment,warehousesandhygienicenvironmentrequiredfordrugdistribution;
(3) havingtheunitsorpersonnelforqualitycontroloverthedrugstobedistributed;and
(4) havingrulesandregulationstoensurethequalityofthedrugtobedistributed.
Article16 DrugdistributorsshallconductbusinessaccordingtotheGoodSupplyPracticeforPharmaceuticalProducts(GSP)formulatedbythedrugregulatorydepartmentundertheStateCouncilonthebasisofthisLaw.ThedrugregulatorydepartmentshallinspectadrugdistributorastoitscompliancewiththeGSPrequirements,andissueacertificatetothedistributorpassingtheinspection.
ThespecificmeasuresandscheduleforimplementingtheGSPshallbeformulatedbythedrugregulatorydepartmentundertheStateCouncil.
Article17 Forpurchasingdrugs,drugdistributorshallestablishandapplyanexaminationandacceptancesystem,andcheckthecertificateofdrugquality,labelandothermarks;nodrugsthatdonotmeettherequirementsmaybepurchased.
Article18 Drugdistributorsshallkeepauthenticandcompleterecordswhenpurchasingandsellingdrugs.IntherecordshallbeindicatedtheadoptednameinChina,dosageform,strengthorsize,batchnumber,dateofexpiry,manufacturer,purchase(orsale)unit,amountofthedrugpurchased(orsold),purchaseorsaleprice,dateofpurchase(orsale),andotheritemsspecifiedbythedrugregulatorydepartmentundertheStateCouncil.
Article19 Drugdistributorsshallselldrugsproperlyandmakecorrectdescriptionofusage,dosageandcautions;prescriptionfordispensingshallbechecked,andnodruglistedintheprescriptionmaybe
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- DRUG ADMINISTRATION LAW OF THE PEOPLES REPUBLIC CHINA
链接地址:https://www.bingdoc.com/p-14248625.html