欧盟指令
-
2023年3月18日发(作者：职业素质)DIRECTIVE2001/83/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of6November2001
ontheCommunitycoderelatingtomedicinalproductsforhumanuse
THEEUROPEANPARLIAMENTANDTHECOUNCILOF
THEEUROPEANUNION,
HavingregardtotheTreatyestablishingtheEuropean
Community,andinparticularArticle95thereof,
HavingregardtotheproposalfromtheCommission;
HavingregardtotheopinionoftheEconomicandSocial
Committee(1),
ActinginaccordancewiththeprocedurelaiddowninArticle
251oftheTreaty(2),
Whereas:
(1)CouncilDirective65/65/EECof26January1965onthe
approximationofprovisionslaiddownbylaw,
regulationoradministrativeactionrelatingtomedicinal
products(3),CouncilDirective75/318/EECof20May
1975ontheapproximationofthelawsofMember
Statesrelatingtoanalytical,pharmaco-toxicologicaland
clinicalstandardsandprotocolsinrespectofthetesting
ofproprietarymedicinalproducts(4),CouncilDirective
75/319/EECof20May1975ontheapproximationof
provisionslaiddownbylaw,regulationor
administrativeactionrelatingtoproprietarymedicinal
products(5),CouncilDirective89/342/EECof3May
1989extendingthescopeofDirectives65/65/EECand
75/319/EECandlayingdownadditionalprovisionsfor
immunologicalmedicinalproductsconsistingof
vaccines,toxinsorserumsandallergens(6),Council
Directive89/343/EECof3May1989extendingthe
scopeofDirectives65/65/EECand75/319/EECand
layingdownadditionalprovisionsfor
radiopharmaceuticals(7),CouncilDirective89/381/EEC
of14June1989extendingthescopeofDirectives
65/65/EECand75/319/EEContheapproximationof
provisionslaiddownbylaw,regulationor
administrativeactionrelatingtomedicinalproductsand
layingdownspecialprovisionsforproprietarymedicinal
productsderivedfromhumanbloodorhuman
plasma(8),CouncilDirective92/25/EECof31March
1992onthewholesaledistributionofmedicinal
productsforhumanuse(9),CouncilDirective
92/26/EECof31March1992concerningthe
classificationforthesupplyofmedicinalproductsfor
humanuse(10),CouncilDirective92/27/EECof31
March1992onthelabellingofmedicinalproductsfor
humanuseandonpackageleaflets(11),Council
Directive92/28/EECof31March1992onthe
advertisingofmedicinalproductsforhumanuse(12),
CouncilDirective92/73/EECof22September1992
wideningthescopeofDirectives65/65/EECand
75/319/EEContheapproximationofprovisionslaid
downbylaw,regulationoradministrativeaction
relatingtomedicinalproductsandlayingdown
additionalprovisionsonhomeopathicmedicinal
products(13)havebeenfrequentlyandsubstantially
nterestsofclarityandrationality,the
saidDirectivesshouldthereforebecodifiedby
assemblingtheminasingletext.
(2)Theessentialaimofanyrulesgoverningtheproduction,
distributionanduseofmedicinalproductsmustbeto
safeguardpublichealth.
(3)However,thisobjectivemustbeattainedbymeans
whichwillnothinderthedevelopmentofthe
pharmaceuticalindustryortradeinmedicinalproducts
withintheCommunity.
(4)TradeinmedicinalproductswithintheCommunityis
hinderedbydisparitiesbetweencertainnational
provisions,inparticularbetweenprovisionsrelatingto
medicinalproducts(excludingsubstancesor
combinationsofsubstanceswhicharefoods,animal
feeding-stuffsortoiletpreparations),andsuchdisparities
directlyaffectthefunctioningoftheinternalmarket.
(5)Suchhindrancesmustaccordinglyberemoved;whereas
thisentailsapproximationoftherelevantprovisions.
(6)Inordertoreducethedisparitieswhichremain,rules
shouldbelaiddownonthecontrolofmedicinal
productsandthedutiesincumbentupontheMember
States'competentauthoritiesshouldbespecifiedwitha
viewtoensuringcompliancewithlegalrequirements.
(1)OJC368,20.12.1999,p.3.
(2)OpinionoftheEuropeanParliamentof3July2001(notyet
publishedintheOfficialJournal)andCouncilDecisionof27
September2001.
(3)OJ22,9.2.1965,p.369/iveaslastamendedbyDirective
93/39/EEC(OJL214,24.8.1993,p.22).
(4)OJL147,9.6.1975,iveaslastamendedby
CommissionDirective1999/83/EC(OJL243,15.9.1999,p.9).
(5)OJL147,9.6.1975,iveaslastamendedby
CommissionDirective2000/38/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.
28.11.2001L311/67OfficialJournaloftheEuropeanCommunities
EN
(7)Theconceptsofharmfulnessandtherapeuticefficacy
canonlybeexaminedinrelationtoeachotherand
haveonlyarelativesignificancedependingonthe
progressofscientificknowledgeandtheuseforwhich
ticularsand
documentswhichmustaccompanyanapplicationfor
marketingauthorizationforamedicinalproduct
demonstratethatpotentialrisksareoutweighedbythe
therapeuticefficacyoftheproduct.
(8)Standardsandprotocolsfortheperformanceoftests
andtrialsonmedicinalproductsareaneffectivemeans
ofcontroloftheseproductsandhenceofprotecting
publichealthandcanfacilitatethemovementofthese
productsbylayingdownuniformrulesapplicableto
testsandtrials,thecompilationofdossiersandthe
examinationofapplications.
(9)Experiencehasshownthatitisadvisabletostipulate
morepreciselythecasesinwhichtheresultsof
toxicologicalandpharmacologicaltestsorclinicaltrials
donothavetobeprovidedwithaviewtoobtaining
authorizationforamedicinalproductwhichis
essentiallysimilartoanauthorizedproduct,while
ensuringthatinnovativefirmsarenotplacedata
disadvantage.
(10)However,therearereasonsofpublicpolicyfornot
conductingrepetitivetestsonhumansoranimals
withoutover-ridingcause.
(11)Theadoptionofthesamestandardsandprotocolsbyall
theMemberStateswillenablethecompetentauthorities
toarriveattheirdecisionsonthebasisofuniformtests
andbyreferencetouniformcriteriaandwilltherefore
helptoavoiddifferencesinevaluation.
(12)Withtheexceptionofthosemedicinalproductswhich
aresubjecttothecentralizedCommunityauthorization
procedureestablishedbyCouncilRegulation(EEC)No
2309/93of22July1993layingdownCommunity
proceduresfortheauthorizationandsupervisionof
medicinalproductsforhumanandveterinaryuseand
establishingaEuropeanAgencyfortheEvaluationof
MedicinalProducts(1)amarketingauthorizationfora
medicinalproductgrantedbyacompetentauthorityin
oneMemberStateoughttoberecognizedbythe
competentauthoritiesoftheotherMemberStatesunless
thereareseriousgroundsforsupposingthatthe
authorizationofthemedicinalproductconcernedmay
ventofa
disagreementbetweenMemberStatesaboutthequality,
thesafetyortheefficacyofamedicinalproduct,a
scientificevaluationofthemattershouldbeundertaken
accordingtoaCommunitystandard,leadingtoasingle
decisionontheareaofdisagreementbindingonthe
sthisdecisionshould
beadoptedbyarapidprocedureensuringclose
cooperationbetweentheCommissionandtheMember
States.
(13)Forthispurpose,aCommitteeforProprietaryMedicinal
ProductsshouldbesetupattachedtotheEuropean
AgencyfortheEvaluationofMedicinalProducts
establishedintheabovementionedRegulation(EEC)No
2309/93.
(14)ThisDirectiverepresentsanimportantsteptowards
achievementoftheobjectiveofthefreemovementof
rmeasuresmayabolishany
remainingbarrierstothefreemovementofproprietary
medicinalproductswillbenecessaryinthelightof
experiencegained,particularlyintheabovementioned
CommitteeforProprietaryMedicinalProducts.
(15)Inorderbettertoprotectpublichealthandavoidany
unnecessaryduplicationofeffortduringthe
examinationofapplicationforamarketing
authorizationformedicinalproducts,MemberStates
shouldsystematicallyprepareassessmentreportsin
respectofeachmedicinalproductwhichisauthorized
bythem,andexchangethereportsuponrequest.
Furthermore,aMemberStateshouldbeabletosuspend
theexaminationofanapplicationforauthorizationto
placeamedicinalproductonthemarketwhichis
currentlyunderactiveconsiderationinanotherMember
Statewithaviewtorecognizingthedecisionreachedby
thelatterMemberState.
(16)Followingtheestablishmentoftheinternalmarket,
specificcontrolstoguaranteethequalityofmedicinal
productsimportedfromthirdcountriescanbewaived
onlyifappropriatearrangementshavebeenmadeby
theCommunitytoensurethatthenecessarycontrols
arecarriedoutintheexportingcountry.
(17)Itisnecessarytoadoptspecificprovisionsfor
immunologicalmedicinalproducts,homeopathic
medicinalproducts,radiopharmaceuticals,andmedicinal
productsbasedonhumanbloodorhumanplasma.
(18)Anyrulesgoverningradiopharmaceuticalsmusttake
intoaccounttheprovisionsofCouncilDirective
84/466/Euratomof3September1984layingdown
basicmeasuresfortheradiationprotectionofpersons
undergoingmedicalexaminationortreatment(2).
AccountshouldalsobetakenofCouncilDirective
80/836/Euratomof15July1980amendingthe
Directiveslayingdownthebasicsafetystandardsforthe
healthprotectionofthegeneralpublicandworkers
(1)OJL214,24.8.1993,tionasamendedbyCommission
Regulation(EC)No649/98(OJL88,24.3.1998,p.7).
(2)OJL265,5.10.1984,iverepealedwitheffectfrom13
May2000byDirective97/43/Euratom(OJL180,9.7.1997,p.
22).
L311/6828.11.2001OfficialJournaloftheEuropeanCommunities
EN
againstthedangersofionizingradiation(1),the
objectiveofwhichistopreventtheexposureofworkers
orpatientstoexcessiveorunnecessarilyhighlevelsof
ionizingradiation,andinparticularofArticle5c
thereof,whichrequirespriorauthorizationforthe
additionofradioactivesubstancestomedicinalproducts
aswellasfortheimportationofsuchmedicinal
products.
(19)TheCommunityentirelysupportstheeffortsofthe
CouncilofEuropetopromotevoluntaryunpaidblood
andplasmadonationtoattainself-sufficiency
throughouttheCommunityinthesupplyofblood
products,andtoensurerespectforethicalprinciplesin
tradeintherapeuticsubstancesofhumanorigin.
(20)Therulesdesignedtoguaranteethequality,safetyand
efficacyofmedicinalproductsderivedfromhuman
bloodorhumanplasmamustbeappliedinthesame
mannertobothpublicandprivateestablishments,and
tobloodandplasmaimportedfromthirdcountries.
(21)Havingregardtotheparticularcharacteristicsofthese
homeopathicmedicinalproducts,suchastheverylow
levelofactiveprinciplestheycontainandthedifficulty
ofapplyingtothemtheconventionalstatisticalmethods
relatingtoclinicaltrials,itisdesirabletoprovidea
special,simplifiedregistrationprocedureforthose
homeopathicmedicinalproductswhichareplacedon
themarketwithouttherapeuticindicationsina
pharmaceuticalformanddosagewhichdonotpresenta
riskforthepatient.
(22)Theanthroposophicmedicinalproductsdescribedinan
officialpharmacopoeiaandpreparedbyahomeopathic
methodaretobetreated,asregardsregistrationand
marketingauthorization,inthesamewayas
homeopathicmedicinalproducts.
(23)Itisdesirableinthefirstinstancetoprovideusersof
thesehomeopathicmedicinalproductswithaveryclear
indicationoftheirhomeopathiccharacterandwith
sufficientguaranteesoftheirqualityandsafety.
(24)Therulesrelatingtothemanufacture,controland
inspectionofhomeopathicmedicinalproductsmustbe
harmonizedtopermitthecirculationthroughoutthe
Communityofmedicinalproductswhicharesafeandof
goodquality.
(25)Theusualrulesgoverningtheauthorizationtomarket
medicinalproductsshouldbeappliedtohomeopathic
medicinalproductsplacedonthemarketwith
therapeuticindicationsorinaformwhichmaypresent
riskswhichmustbebalancedagainstthedesired
icular,thoseMemberStates
whichhaveahomeopathictraditionshouldbeableto
applyparticularrulesfortheevaluationoftheresultsof
testsandtrialsintendedtoestablishthesafetyand
efficacyofthesemedicinalproductsprovidedthatthey
notifythemtotheCommission.
(26)Inordertofacilitatethemovementofmedicinal
productsandtopreventthecontrolscarriedoutinone
MemberStatefrombeingrepeatedinanother,
minimumrequirementsshouldbelaiddownfor
manufactureandimportscomingfromthirdcountries
andforthegrantoftheauthorizationrelatingthereto.
(27)Itshouldbeensuredthat,intheMemberStates,the
supervisionandcontrolofthemanufactureofmedicinal
productsiscarriedoutbyapersonwhofulfils
minimumconditionsofqualification.
(28)Beforeanauthorizationtomarketanimmunological
medicinalproductorderivedfromhumanbloodor
humanplasmacanbegranted,themanufacturermust
demonstratehisabilitytoattainbatch-to-batch
anauthorizationtomarketa
medicinalproductderivedfromhumanbloodorhuman
plasmacanbegranted,themanufacturermustalso
demonstratetheabsenceofspecificviralcontamination,
totheextentthatthestateoftechnologypermits.
(29)Theconditionsgoverningthesupplyofmedicinal
productstothepublicshouldbeharmonized.
(30)Inthisconnectionpersonsmovingaroundwithinthe
Communityhavetherighttocarryareasonable
quantityofmedicinalproductslawfullyobtainedfor
alsobepossibleforaperson
establishedinoneMemberStatetoreceivefromanother
MemberStateareasonablequantityofmedicinal
productsintendedforhispersonaluse.
(31)Inaddition,byvirtueofRegulation(EC)No2309/93,
certainmedicinalproductsarethesubjectofa
context,
theclassificationforthesupplyofmedicinalproducts
coveredbyaCommunitymarketingauthorizationneeds
ereforeimportanttosetthe
criteriaonthebasisofwhichCommunitydecisionswill
betaken.
(32)Itisthereforeappropriate,asaninitialstep,to
harmonizethebasicprinciplesapplicabletothe
classificationforthesupplyofmedicinalproductsinthe
CommunityorintheMemberStateconcerned,while
takingasastartingpointtheprinciplesalready
establishedonthissubjectbytheCouncilofEuropeas
wellastheworkofharmonizationcompletedwithinthe
frameworkoftheUnitedNations,concerningnarcotic
andpsychotropicsubstances.
(1)OJL246,17.9.1980,iveasamendedbyDirective
84/467/Euratom(OJL265,5.10.1984,p.4),repealedwitheffect
from13May2000byDirective96/29/Euratom(OJL314,
4.12.1996,p.20).
28.11.2001L311/69OfficialJournaloftheEuropeanCommunities
EN
(33)Theprovisionsdealingwiththeclassificationof
medicinalproductsforthepurposeofsupplydonot
infringethenationalsocialsecurityarrangementsfor
reimbursementorpaymentformedicinalproductson
prescription.
(34)Manyoperationsinvolvingthewholesaledistributionof
medicinalproductsforhumanusemaycoverseveral
MemberStatessimultaneously.
(35)Itisnecessarytoexercisecontrolovertheentirechain
ofdistributionofmedicinalproducts,fromtheir
manufactureorimportintotheCommunitythroughto
supplytothepublic,soastoguaranteethatsuch
productsarestored,transportedandhandledinsuitable
uirementswhichmustbeadopted
forthispurposewillconsiderablyfacilitatethe
withdrawalofdefectiveproductsfromthemarketand
allowmoreeffectiveeffortsagainstcounterfeitproducts.
(36)Anypersoninvolvedinthewholesaledistributionof
medicinalproductsshouldbeinpossessionofaspecial
cistsandpersonsauthorizedto
supplymedicinalproductstothepublic,andwho
confinethemselvestothisactivity,shouldbeexempt
wever
necessary,inordertocontrolthecompletechainof
distributionofmedicinalproducts,thatpharmacistsand
personsauthorizedtosupplymedicinalproductstothe
publickeeprecordsshowingtransactionsinproducts
received.
(37)Authorizationmustbesubjecttocertainessential
conditionsanditistheresponsibilityoftheMember
Stateconcernedtoensurethatsuchconditionsaremet;
whereaseachMemberStatemustrecognize
authorizationsgrantedbyotherMemberStates.
(38)CertainMemberStatesimposeonwholesalerswho
supplymedicinalproductstopharmacistsandon
personsauthorizedtosupplymedicinalproductstothe
ember
Statesmustbeabletocontinuetoimposethose
obligationsonwholesalersestablishedwithintheir
stalsobeabletoimposethemon
wholesalersinotherMemberStatesonconditionthat
theydonotimposeanyobligationmorestringentthan
thosewhichtheyimposeontheirownwholesalersand
providedthatsuchobligationsmayberegardedas
warrantedongroundsofpublichealthprotectionand
areproportionateinrelationtotheobjectiveofsuch
protection.
(39)Rulesshouldbelaiddownastohowthelabellingand
packageleafletsaretobepresented.
(40)Theprovisionsgoverningtheinformationsuppliedto
usersshouldprovideahighdegreeofconsumer
protection,inorderthatmedicinalproductsmaybe
usedcorrectlyonthebasisoffullandcomprehensible
information.
(41)Themarketingofmedicinalproductswhoselabelling
andpackageleafletscomplywiththisDirectiveshould
notbeprohibitedorimpededongroundsconnected
withthelabellingorpackageleaflet.
(42)ThisDirectiveiswithoutprejudicetotheapplicationof
measuresadoptedpursuanttoCouncilDirective
84/450/EECof10September1984relatingtothe
approximationofthelaws,regulationsand
administrativeprovisionsoftheMemberStates
concerningmisleadingadvertising(1).
(43)AllMemberStateshaveadoptedfurtherspecific
measuresconcerningtheadvertisingofmedicinal
redisparitiesbetweenthesemeasures.
Thesedisparitiesarelikelytohaveanimpactonthe
functioningoftheinternalmarket,sinceadvertising
disseminatedinoneMemberStateislikelytohave
effectsinotherMemberStates.
(44)CouncilDirective89/552/EECof3October1989on
thecoordinationofcertainprovisionslaiddownbylaw,
regulationoradministrativeactioninMemberStates
concerningthepursuitoftelevisionbroadcasting
activities(2)prohibitsthetelevisionadvertisingof
medicinalproductswhichareavailableonlyonmedical
prescriptionintheMemberStatewithinwhose
principleshouldbemadeofgeneralapplicationby
extendingittoothermedia.
(45)Advertisingtothegeneralpublic,evenof
non-prescriptionmedicinalproducts,couldaffectpublic
health,wereittobeexcessiveandill-considered.
Advertisingofmedicinalproductstothegeneralpublic,
whereitispermitted,oughtthereforetosatisfycertain
essentialcriteriawhichoughttobedefined.
(46)Furthermore,distributionofsamplesfreeofchargeto
thegeneralpublicforpromotionalendsmustbe
prohibited.
(47)Theadvertisingofmedicinalproductstopersons
qualifiedtoprescribeorsupplythemcontributestothe
heless,this
advertisingshouldbesubjecttostrictconditionsand
effectivemonitoring,referringinparticulartothework
carriedoutwithintheframeworkoftheCouncilof
Europe.
(48)Advertisingofmedicinalproductsshouldbesubjectto
effective,nceinthisregard
shouldbemadetothemonitoringmechanismssetup
byDirective84/450/EEC.
(49)Medicalsalesrepresentativeshaveanimportantrolein
ore,certain
obligationsshouldbeimposeduponthem,inparticular
theobligationtosupplythepersonvisitedwitha
summaryofproductcharacteristics.
(1)OJL250,19.9.1984,iveasamendedbyDirective
97/55/EC(OJL290,23.10.1997,p.18).
(2)OJL298,17.10.1989,iveasamendedbyDirective
97/36/EC(OJL202,30.7.1997,p.60).
L311/7028.11.2001OfficialJournaloftheEuropeanCommunities
EN
(50)Personsqualifiedtoprescribemedicinalproductsmust
beabletocarryoutthesefunctionsobjectivelywithout
beinginfluencedbydirectorindirectfinancial
inducements.
(51)Itshouldbepossiblewithincertainrestrictiveconditions
toprovidesamplesofmedicinalproductsfreeofcharge
topersonsqualifiedtoprescribeorsupplythemsothat
theycanfamiliarizethemselveswithnewproductsand
acquireexperienceindealingwiththem.
(52)Personsqualifiedtoprescribeorsupplymedicinal
productsmusthaveaccesstoaneutral,objectivesource
ofinformationaboutproductsavailableonthemarket.
WhereasitisneverthelessfortheMemberStatestotake
allmeasuresnecessarytothisend,inthelightoftheir
ownparticularsituation.
(53)Eachundertakingwhichmanufacturesorimports
medicinalproductsshouldsetupamechanismto
ensurethatallinformationsuppliedaboutamedicinal
productconformswiththeapprovedconditionsofuse.
(54)Inordertoensurethecontinuedsafetyofmedicinal
productsinuse,itisnecessarytoensurethat
pharmacovigilancesystemsintheCommunityare
continuallyadaptedtotakeaccountofscientificand
technicalprogress.
(55)Itisnecessarytotakeaccountofchangesarisingasa
resultofinternationalharmonisationofdefinitions,
terminologyandtechnologicaldevelopmentsinthefield
ofpharmacovigilance.
(56)Theincreasinguseofelectronicnetworksfor
communicationofinformationonadversereactionsto
medicinalproductsmarketedintheCommunityis
intendedtoallowcompetentauthoritiestosharethe
informationatthesametime.
(57)ItistheinterestoftheCommunitytoensurethatthe
pharmacovigilancesystemsforcentrallyauthorised
medicinalproductsandthoseauthorisedbyother
proceduresareconsistent.
(58)Holdersofmarketingauthorisationsshouldbe
proactivelyresponsibleforon-goingpharmacovigilance
ofthemedicinalproductstheyplaceonthemarket.
(59)Themeasuresnecessaryfortheimplementationofthis
DirectiveshouldbeadoptedinaccordancewithCouncil
Decision1999/468/ECof28June1999layingdown
theproceduresfortheexerciseofimplementingpowers
conferredontheCommission(1).
(60)TheCommissionshouldbeempoweredtoadoptany
necessarychangestoAnnexIinordertotakeinto
accountscientificandtechnicalprogress.
(61)ThisDirectiveshouldbewithoutprejudicetothe
obligationsoftheMemberStatesconcerningthe
time-limitsfortranspositionoftheDirectivessetoutin
AnnexII,PartB.
HAVEADOPTEDTHISDIRECTIVE:
TITLEI
DEFINITIONS
Article1
ForthepurposesofthisDirective,thefollowingtermsshall
bearthefollowingmeanings:
etarymedicinalproduct:
Anyready-preparedmedicinalproductplacedonthe
marketunderaspecialnameandinaspecialpack.
nalproduct:
Anysubstanceorcombinationofsubstancespresented
fortreatingorpreventingdiseaseinhumanbeings.
Anysubstanceorcombinationofsubstanceswhichmay
beadministeredtohumanbeingswithaviewtomaking
amedicaldiagnosisortorestoring,correctingor
modifyingphysiologicalfunctionsinhumanbeingsis
likewiseconsideredamedicinalproduct.
nce:
Anymatterirrespectiveoforiginwhichmaybe: