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DOCUMENTS "COM"
COM(81)803
Vol.1981/0225

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COMMISSION OFTHEEUROPEAN COMMUNITIES
/
COM(81)803 final
Brussels.17thDecember1981
PARALLEL IMPORTS OFPROPRIETARY MEDICINAL PRODUCTS FOR
WHICHMARKETING AUTHORIZATIONS HAVEALREADYBEENGRANTED
(Communication fromtheCommission totheCouncil)
V,-"'A .« ,/
Lp' ^W? /
COM(81)803final

COMMISSION COMMUNICATION
ONPARALLEL IMPORTS OFPROPRIETARY MEDICINAL PRODUCTS
FORWHICHMARKETING AUTHORIZATIONS HAVEALREADY BEENGRANTED
Inorderprogressively toestablishthefreemovementofproprietary medicinal
1products,theCouncilhasadoptedfourDirectives essentially relatingto
theconditionsinwhichtheMemberStatesdelivermarketingauthorizations
fortheseproducts.
Furthermore/inthe"DePeijper"case"2,theCourtofJusticeoftheEuropean
Communities,towhichthematterwasreferredunderArticle177oftheEEC
Treaty,hasdelivered ajudgmentonparallelimportsofmedicinalproducts.
ThisjudgmentgivestheCommissioninterpretative rulingsenablingitto
exercisemorestringentchecksontheapplication oftherulesoftheTreaty
onfreemovementofgoods,inparticulartheprovisionsofArticles30-36of
theEECTreaty.
Followingthisjudgment,theCommission considereditnecessarytosupplement
theexistingDirectives bytransmitting totheCouncilon2June1980a
proposalforaDirective^relatingtoparallelimportsofproprietary
medicinalproducts.
./.
Directive 65/65/EECof26January1965,OJNo22,9.2.1965
Directive 75/318/EECof20May1975,OJL147,9.6.1975
Directive 75/319/EECof20May1975,OJL147,9.6.1975
Directive 78/25/EECof12December1977,OJL11,14.1.1978
2CJEC20May1976,case104/75,1976Report,p.613
Proposaldated2June1980foraDirectiveamendingDirectives 65/65/EEC
and75/319/EEC,0JC143,.12.6.1980.

TheCommission ha.ctakennoteeftheobjectionsraisedbytheleonomieand
SocialCommitteetotheproposalrelatingtoparallelimportsandthe
negativevotetakenonthatproposalbytheEuropeanParliamenton16October
1981.
TheCommissionhasthereforedecidedtowithdrawitsproposal,especiallyas
itsadoptionbytheCouncilappearsimprobableinthepresentcircumstances .
TheCommissionisnot,however,abandoningitsresponsibility toensurethat
fulleffectisgiventotheprovisionsoftheTreatyrelatingtothefree
movementofgoods.TheParliamentstressedduringitsdiscussion andinthe
textofitsResolutionitsattachmenttotheprincipleoffreemovement.This
iswhytheCommissionwishestoindicate,ontheoccasionofthiswithdrawal,
thewayinwhichitintendstoapply,underitsownresponsibility ,the
rulesembodiedintheTreatyasinterpreted bytheCourtofJustice,inorder
topreservetheunityoftheCommunity'sinternalmarket.

-3-
Incase104/75,theCourthadtogivearulingonasetofhealthregulations
relatingtothemarketingofmedicinalproductsthatpreventedthemarketing
ofamedicinalproductintroducedasaparallelimport.
TheCourtfirstofallestablishedthatnationalrulesorpracticeswhich
resultinimportsbeingchannelledinsuchawaythatonlycertaintraders
caneffecttheseimports,whereasothersarepreventedfromdoingso,are
caughtbytheprohibitionsetoutinArticle30oftheEECTreaty.
TheCourtwentontoreaffirmtheMemberStates'right,inpursuanceof
Article36oftheEECTreaty,todecide,subjecttothelimitations imposed
bytheTreaty,onthelevelofprotectiontheywishtoaffordforthe
healthandlifeofpersons,inparticularthestringencyofthechecksto
becarriedout.
Itnevertheless immediatelystressedthegeneralcontextinwhichthis
competence oftheMemberStateswastobeexercised :
"Nationalrulesorpracticeswhichdorestrictimportsofpharmaceutical
productsorarecapableofdoingsoareonlycompatiblewiththeTreatyto
theextenttowhichtheyarenecessaryfortheeffectiveprotectionofhealth
andlifeofhumans.
Nationalrulesorpracticesdonotfallwithintheexceptionspecifiedin
Article36ifthehealthandlifeofhumanscanbeaseffectivelyprotected
bymeasureswhichdonotrestrictintra-Community tradesomuch.
InparticularArticle36cannotbereliedontojustifyrulesorpractices
which,eventhoughtheyarebeneficial,containrestrictions whichare
explainedprimarilybyaconcerntolightentheadministration 'sburdenor
reducepublicexpenditure,unless,intheabsenceofthesaidrulesor
practices,thisburdenorexpenditureclearlywouldexceedthelimitsof
whatcanreasonablyberequired."

-4-
Inthecaseinpoin>.,thecompetentnationalauthorities intendedtoprevent
aparallelimporterfrommarketingamedicinalproductthatwassimilarto
amedicinalproductwhichhadalreadybeenauthorized andwasproducedby
thesamemanufacturer,fortworeasons.
First,theparallelmanufacturer wasnotabletoprovidetheauthorities
withthecompletefilerelatingtothequality,efficacyandsafetyof
theproductingeneral,whichthemanufacturer'sauthorizedimporterhad
alreadysuppliedtothosesameauthorities withaviewtoobtaininga
marketingauthorization forthatmedicinalproduct.
Secondly,theparallelimportercouldnot,unliketheauthorizedimporter,
obtainfromthemanufacturer thereportsonchecksmadeoneachmanufac­
turingbatch.
Inthejudgmentonthe"DePeijper"case,theCourtruledthat
"nationalrulesorpracticeswhichmakeitpossibleforamanufacturer of
thepharmaceutical productinquestionandhisdulyappointedrepresentative ,
simplybyrefusingtoproducethedocumentsrelatingtothemedicinal
preparation ingeneralortoaspecificbatchofthatpreparation,to
enjoyamonopolyoftheimportingandmarketingoftheproduct,must
beregardedasbeingunnecessarily restrictive,unlessitisclearlyproved
thatanyotherrulesorpracticeswouldobviouslybebeyondthemeanswhich
canbereasonablyexpectedofanadministration operatinginanormal
manner..
"Itisonlyiftheinformation ordocumentstobeproducedbythemanu­
facturerorhisdulyappointedimportershowthatthereareseveral
variantsofthemedicinalpreparation andthatthedifferences between
thesevariantshaveatherapeuticeffectthattherewouldbeanyjustifi­
cationfortreatingthevariantsasdifferentmedicinalpreparations,
forthepurposeofauthorizing themtobeplacedonthemarketandas
regardsproducingtherelevantdocuments...".
* *
1Thisfilecomprises,interalia,adescriptionofthemanufacturer's
production andcontrolmethodsandtheresultsoftheanalytical,
toxico-pharmacologi calandclinicaltestsconductedonthemedicinal
productingeneral.

-5-
TheCommission,inItsroleasguardianoftheTreaty,willepsurethatthe
rulesandpracticesappliedbyMemberStatestoparallelimportsofmedicinal
products,andinparticularproprietary medicinalproductswhichaccountfor
themajorityofintra-Community tradingoperationsinmedicinalproducts,
I
willremainwithinlimitscompatiblewithArticles30-36.
Inparticular,suchmeasuresmust:
-bestrictlynecessaryfromthehealthstandpoint,
-obstructintra-Community tradeaslittleaspossible,
-requiretheMemberStatestoadoptanactiveandvigilantattitudetowards
pharmaceutical companies.
TheCommissionpointsoutthatthecompetentauthorities intheMemberStates
arenotentitledtoopposethemarketingofanymedicinalproduct,thesubject
ofparallelimportation,thatalreadyhasamarketingauthorization ,onthe
groundsthattheparallelimporterisnotabletoobtaindocumentswhich
onlythemanufacturer orhisapprovedrepresentative canhaveattheir
disposal.
Intheabsenceofanyharmonizedrulesgoverningthesystemofparallel
imports,itisuptotheCommission,inaccordancewiththeprocedureunder
Article169,andtotheinterestedparties,inaccordancewiththemeansof
redresswhichtheyhaveattheirdisposal,toensurethatparallelimports
ofmedicinalproductsaremadepossibleundertheconditionslaiddownby
therulingsoftheCourt.
AfterconsultingseniorexpertsinpublichealthmattersfromtheMember
1States'administrations meetinginthePharmaceutical Committee,the
Commissionhadproposedauniformsystemforparallelimportsofproprietary
medicinalproducts.Despitethewithdrawalofitsproposal,theCommission
considersitusefultoindicatesavewaysofmonitoringparallelimports
which,subjecttotherulingsoftheCourt,seemtoittobejustifiedfor
thepurposeofprotectingthehealthandlifeofhumanspursuantto
Article36oftheTreaty.
SetupbyCouncilDecision75/320/EECof20May1975,0JL147/9.6.1975.

-6-
TheCemnHssienpoints©utthattheeempetentautherltlet oftheMemberState#
alreadyhaveattheirdisposaltwoimportantsafeguardsforhealthinthe
caseofparallelimportsofproprietary medicinalproducts.
Ontheonehand,thenationalrulesgoverningtheactivitiesofimporters,
wholesalers and,whereapplicable,manufacturers ofproprietarymedicinal
productsapplyequallytoparallelimporters.Theserulesusuallycover
professional competence andresponsibilities ,thetechnicalpremisesand
equipmentrequiredandtherulesfortheoperationofsuchestablishments ,
inparticulartheproceduresrelatingtothepreservation ofdocumentsto
facilitateofficialchecksandinspections .
Ontheotherhand,theauthorities competenttoissuemarketingauthorizations
forproprietarymedicinalproductsalready,asarule,possessthedossier
relatingtothequality,efficacyandsafetyofthemedicinalproductin
general,whichhasbeensuppliedbythemanufacturer orhisapprovedimporter
andwhichstates,inpursuanceofArticle4(11)ofDirective65/65/EEC,
theauthorizations alreadyobtainedfortheproductinanyotherMember
State.AccordingtotheCourt,thecompetentadministration oftheimporting
MemberStateisclearlyentitledtorequirethemanufacturer,orhisduly
appointedimporter,tojStatewhetherthemanufacturer,orthegroupofmanu­
facturerstowhichhebelongs,producesseveralvariantsofthesame
medicinalproductfordifferentMemberStates.Ifthisisso,itisonlyif
thedocumentssubmittedbythemanufacturer showthattherearedifferences
havingatherapeuticeffectthattherewouldbeanyjustification for
treatingthevariantsasdifferentmedicinalproductsforthepurposeof
marketingauthorization .
Inadditiontothesesafeguards,theauthorities havealegitimateinterest
inbeingabletoverify,atalltimesandbeyonddoubt,whetherthebatches
ofimportedmedicinalproductsareinconformitywiththeparticulars
containedinthedossier.

TheCommissionconcedesthattheparallelimportermayberequiredtosupply
thecompetentauthoritiesintheMemberStateintowhichtheproductis
importedwithcertaininformationreadilyaccessibletohimwhenhewants
tomarketforthefirsttimeaproprietarymedicinalproductalreadymarketed
bythemanufacturer orhisdulyappointedrepresentative .
Thisinformation mustallowthecompetentauthorities intheMemberState
intowhichtheproductisimportedtocheck,withinareasonableperiod,
thattheproprietarymedicinalproductthatisthesubjectofparallel
importationiseffectively coveredbythemarketingauthorization already
grantedtothemanufacturer orhisdulyappointedrepresentative .Inthe
Commission'sview,thisperiodshouldnotexceed45daysfromthetimethe
parallelimportergivesthefollowinginformationtothecompetent
authorities :
(a)nameoftheproprietary medicinalproductintheMemberStateintowhich
itisimportedandintheMemberStatefromwhichitcomes;
(b)nameorcorporatenameandpermanentaddressofthepersonresponsible
forplacingtheproductonthemarketintheMemberStateintowhich
itisimportedandintheMemberStatefromwhichitcomes,andwhere
appropriate,ofthemanufacturer (s);
<c)nameorcorporatenameandpermanentaddressoftheparallelimporter;
(d)numbersofthemarketingauthorizations intheMemberStateintowhich
theproductisimportedandintheMemberStatefromwhichitcomes;
(e)anyothergeneralinformationusefulforthemarketingoftheproprietary
medicinalproductintheMemberStateintowhichitisimported,i.e.
-qualitative andquantitative compositionintermsofactiveprinciples,
bydosageunitorinpercentage,usingtheinternational non-proprietary
namesrecommended bytheWorldHealthOrganisation wheresuchnames
exist,
-pharmaceuticalfolrmandrouteofadministration,
-therapeuticindications andnormaldosage,

-8- |•
-contra-indications andmainside-effects
-storageprecautions,ifany;
(f)oneorworespecimensormock-upsoftheproprietary productintheform
inwhichitwillbemarketedintheMemberStateintowhichitisimported,
includingthepackageLeaflet,ifany.
Toenabletheauthoritiestobeeffectively informedofthemarketingofeach
batchoftheproductimported,theparallelimportershould,intheCommis­
sion'sview,registertheorigin,quantityandbatchnumbersoftheimported
medicinalproductswheneverheimportsthem,andholdthisinformationat
thedisposalofthecompetentauthorities .
TheCommissionpointsoutthatpursuanttoChapterIVofDirective75/319/EEC
eachbatchofproprietary medicinalproductsmanufactured inaMemberState
ischeckedbythemanufacturer whomakesoutacertificate andregistersthe
operationscarriedoutindocumentsthatremainatthedisposalofthe
agentsofthecompetentauthorityforatleastfiveyears.Becausethese
controlreportsaresenttohimbythemanufacturer,thedulyappointed
importerisexemptfromrepeatingthecontrolsintheMemberStateintowhich
theproductisimported.
Sincetheparallelimporterdoesnothaveaccesstothesecontrolreports,
thenationalauthorities havetoadoptamoreactivepolicywhentheywish
toverifythecontrolscarriedoutbythemanufacturer onagivenbatch.
Theycanchooseforthispurposeoneofthefourapproachesgiveninthe
DePeijperjudgment,i.e.:
-theycanobtainthemanufacturing controlreportsbytakinglegislative or
administrative measurescompellingthemanufacturer himself,orhisduly
appointedrepresentative ,tosupplythem;
-theycanobtainthesereportsthroughtheauthorities inthecountryof
manufacture ;
-theycan,wheneverpossible,laydownapresumption ofconformitywiththe
specifications ofthemedicamentanditwouldbeuptothem,inappropriate
cases,torebutthispresumptionafterverification oftheconformity;
-asfarasthispresumptionisfullyimpractibable ,theycanallowthe
parallelimportertoprovideproofofconformitybyanymeansotherthan
bydocumentstowhichhehasnoaccess.

Theparallelimporterisliable,Inthesamewayasthepersonresponsible
formarketing,tothemeasurestakenbytheMemberStatestowithdrawthe
product,tosuspendorrevoketheauthorization ortoprohibitsupplyof
theproduct,pursuanttoArticle28ofDirective75/319/EEC.
*
* *
Byappropriatecooperation betweentheMemberStateauthorities,itwould
bepossibletosupplement,ifnecessary,themonitoringmeasurescompatible
withArticle36oftheTreaty,designedtochecktheconformityofmedicinal
productsimportedinparallel.
IntheDePeijperjudgment,theCourtheldthatsimplecooperation between
theauthorities oftheMemberStateswouldenablethemtoobtainona
reciprocalbasisthedocumentsnecessaryforcheckingcertainlargely
standardized andwidelydistributed products.
Inadditiontotheobligations resultingfromArticle5oftheEECTreaty,
theobligationforthecompetentauthoritiestocommunicatetoeachother
suchinformation asisappropriatetoguaranteethattherequirements for
themarketingormanufacturing authorizations arefulfilledisspecifically
spelledoutinArticle30ofDirective 75/319/EEC.
TheCommissionforitspartispreparedtodoeverythingitcantoassist
theMemberStatesinexchangingtheinformation theyconsidernecessaryto
checktheconformityofparallelimportsofproprietarymedicinalproducts.

-10-
TheCommissionconsidersthattheCommitteeforProprietary MedicinalProducts,
setupbyDirective75/319/EEC,providesasuitableforumforanyexchanges
ofinformation betweentherepresentatives oftheMemberStatesresponsible
formarketingauthorizations forproprietary medicinalproducts.TheCommission
alsoholdsatthedisposalofMemberStatesacontinuously updatedlistof
thepersonsappointedbythecompetentauthoritiestosupplyatshortnotice
anynecessaryinformation onmarketingormanufacturing authorizations in
applicationofArticles30and33ofDirective75/319/EEC.
«
}
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