19欧盟2001-83-EC指令

DIRECTIVE2001/83/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof6November2001ontheCommunitycoderelatingtomedicinalproductsforhumanuseTHEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle95thereof,HavingregardtotheproposalfromtheCommission;HavingregardtotheopinionoftheEconomicandSocialCommittee(1),ActinginaccordancewiththeprocedurelaiddowninArticle251oftheTreaty(2),Whereas:(1)CouncilDirective65/65/EECof26January1965ontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtomedicinalproducts(3),CouncilDirective75/318/EECof20May1975ontheapproximationofthelawsofMemberStatesrelatingtoanalytical,pharmaco-toxicologicalandclinicalstandardsandprotocolsinrespectofthetestingofproprietarymedicinalproducts(4),CouncilDirective75/319/EECof20May1975ontheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtoproprietarymedicinalproducts(5),CouncilDirective89/342/EECof3May1989extendingthescopeofDirectives65/65/EECand75/319/EECandlayingdownadditionalprovisionsforimmunologicalmedicinalproductsconsistingofvaccines,toxinsorserumsandallergens(6),CouncilDirective89/343/EECof3May1989extendingthescopeofDirectives65/65/EECand75/319/EECandlayingdownadditionalprovisionsforradiopharmaceuticals(7),CouncilDirective89/381/EECof14June1989extendingthescopeofDirectives65/65/EECand75/319/EEContheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtomedicinalproductsandlayingdownspecialprovisionsforproprietarymedicinalproductsderivedfromhumanbloodorhumanplasma(8),CouncilDirective92/25/EECof31March1992onthewholesaledistributionofmedicinalproductsforhumanuse(9),CouncilDirective92/26/EECof31March1992concerningtheclassificationforthesupplyofmedicinalproductsforhumanuse(10),CouncilDirective92/27/EECof31March1992onthelabellingofmedicinalproductsforhumanuseandonpackageleaflets(11),CouncilDirective92/28/EECof31March1992ontheadvertisingofmedicinalproductsforhumanuse(12),CouncilDirective92/73/EECof22September1992wideningthescopeofDirectives65/65/EECand75/319/EEContheapproximationofprovisionslaiddownbylaw,regulationoradministrativeactionrelatingtomedicinalproductsandlayingdownadditionalprovisionsonhomeopathicmedicinalproducts(13)havebeenfrequentlyandsubstantiallyamended.Intheinterestsofclarityandrationality,thesaidDirectivesshouldthereforebecodifiedbyassemblingtheminasingletext.(2)Theessentialaimofanyrulesgoverningtheproduction,distributionanduseofmedicinalproductsmustbetosafeguardpublichealth.(3)However,thisobjectivemustbeattainedbymeanswhichwillnothinderthedevelopmentofthepharmaceuticalindustryortradeinmedicinalproductswithintheCommunity.(4)TradeinmedicinalproductswithintheCommunityishinderedbydisparitiesbetweencertainnationalprovisions,inparticularbetweenprovisionsrelatingtomedicinalproducts(excludingsubstancesorcombinationsofsubstanceswhicharefoods,animalfeeding-stuffsortoiletpreparations),andsuchdisparitiesdirectlyaffectthefunctioningoftheinternalmarket.(5)Suchhindrancesmustaccordinglyberemoved;whereasthisentailsapproximationoftherelevantprovisions.(6)Inordertoreducethedisparitieswhichremain,rulesshouldbelaiddownonthecontrolofmedicinalproductsandthedutiesincumbentupontheMemberStates'competentauthoritiesshouldbespecifiedwithaviewtoensuringcompliancewithlegalrequirements.(1)OJC368,20.12.1999,p.3.(2)OpinionoftheEuropeanParliamentof3July2001(notyetpublishedintheOfficialJournal)andCouncilDecisionof27September2001.(3)OJ22,9.2.1965,p.369/65.DirectiveaslastamendedbyDirective93/39/EEC(OJL214,24.8.1993,p.22).(4)OJL147,9.6.1975,p.1.DirectiveaslastamendedbyCommissionDirective1999/83/EC(OJL243,15.9.1999,p.9).(5)OJL147,9.6.1975,p.13.DirectiveaslastamendedbyCommissionDirective2000/38/EC(OJL139,10.6.2000,p.28).(6)OJL142,25.5.1989,p.14.(7)OJL142,25.5.1989,p.16.(8)OJL181,28.6.1989,p.44.(9)OJL113,30.4.1992,p.1.(10)OJL113,30.4.1992,p.5.(11)OJL113,30.4.1992,p.8.(12)OJL113,30.4.1992,p.13.(13)OJL297,13.10.1992,p.8.28.11.2001L311/67OfficialJournaloftheEuropeanCommunitiesEN(7)Theconceptsofharmfulnessandtherapeuticefficacycanonlybeexaminedinrelationtoeachotherandhaveonlyarelativesignificancedependingontheprogressofscientificknowledgeandtheuseforwhichthemedicinalproductisintended.Theparticularsanddocumentswhichmustaccompanyanapplicationformarketingauthorizationforamedicinalproductdemonstratethatpotentialrisksareoutweighedbythetherapeuticefficacyoftheproduct.(8)Standardsandprotocolsfortheperformanceoftestsandtrialsonmedicinalproductsareaneffectivemeansofcontroloftheseproductsandhenceofprotectingpublichealthandcanfacilitatethemovementoftheseproductsbylayingdownuniformrulesapplicabletotestsandtrials,thecompilationofdossiersandtheexaminationofapplications.(9)Experiencehasshownthatitisadvisabletostipulatemorepreciselythecasesinwhichtheresultsoftoxicologicalandpharmacologicaltestsorclinicaltrialsdonothavetobeprovidedwithaviewtoobtainingauthorizationforamedicinalproductwhichisessentiallysimilartoanauthorizedproduct,whileensuringthati