ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(80)267
Vol.1980/0101

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(80)267 final
Brussels,28May1980
Proposalfora
COUNCILDIRECTIVE
amendingDirectives 65/65/EECand75/319/EECon
theapproximation ofprovisionslaiddownbylaw,
regulationoradministrative actionrelatingto
proprietarymedicinalproducts
ΪH
(presentedbytheCommissiontovtheCouncil)V
fileIs
C0M(80)267final
I

7«»epptiontC .prov ■~i">n£ 'f-oto■f~hs»v^oo"v:andftarkPtim,'.or
proprietary medicirslproducts^3vebeenthesubjecto?aserieso*'
CouncilDirectives (65/65/EtCof26January1965,,75/318/2ECand
75/3'^/PECof?0May197S)„
Inajudgmentof26Msy1^76(Case10&/75^DePeijper)-/19767ECR613/,
theCourtofJustice'wascalledupontodecideonthecompatibility wit<)
theTreaty,andinparticularwithArticles30etseq.,ofcertain
nationalpracticeswhichleadtochannelling importsinsuchawaythat
onlycertaineconomicoperatorscanundertakethem,othersbeimjexcluded
fromdoingso.
Inaccordance withtheCourt'sjudgment,stepsmustbetakentoprevent
theregulations andpracticesallowing"themanufacturer ofthe
pharmaceutical productinquestionandhisdulyappointe'd'representatives
simplybyrefusingtoproducethedocumentsretatingtothemedicinal
preparation ingeneralorto>aspecificbatchofthatpreparation,to
enjoyamonopolyoftheimporting andmarketingoftheproduct."Itmust
' ' ><
alsobeensuredthatthehealthandlifeofpersonscanbeprotected j
effectively bymeasureswhicharelessrestrictive tointra-Community '
tradewithoutit"obviouslybeingbeyondthemeanswhichcanreasonably
beexpectedofan-administrationoperatinginanormalmanner".
.ItappearsthattheMemberStateshavenotalldrawnthesameconclusions
fromthisjudgmentoftheCourtofJustice.Somehaveamendedtheirlaws;
others,withoutamendingthem,havebeentacitlyinfavourofremoving
themonopolypositioninrespectoftheimportandmarketingof
proprietary medicinalproductsofthemanufacturer andhisapproved
representatives .
Under.theseconditions,evenif,astheCourthaspointedout,theMember
Statescannotinvokedirectives inordertoavoidtheobligations Laid'
downintheTreaty,itseemsadvisabletosupplementtheCommunity }
Directives inordertoremovethebarriers. -

Toattaintheseends,theprovisions ofDirective 65/65/EECmustbe
supplemented byasystemofregistration ofparallelimporters :the
parallelimportersareregistered asthepersonsresponsibleformarketing
whentheproductimportedandtheproductauthorized areidentical
(firstsubparagraph ofArticle1(4)).Thus,onecandrawaclear
distinction betweentheproductwhichreceives amarketingauthorization
andthepersonsresponsible foritsmarketing,whoareregistered .
Theapplicantforregistration suppliestheinformation hehasreadily
available (secondsubparagraph ofArticle1(4)).
Thecompetentauthoritywillbeabletoexaminewithoutdelaythe
conformityoftheproductimportedinparallelwiththeauthorized
product:itwillbeobligatoryfortheapplicantforthemarketing
authorization toshowinhisfileanychangesmadetotheproductinthe
variousMemberStatesandtosupplytheparticulars and.documents
concerning ^uchchangesandtokeephisfileuptodate(Article1(1)).
I
• ' ι
Inordertoavoidpurelyformalchangesinproducts,whichwouldmake
thesupervision ofthemarketthatdevolvesonthecompetentauthorities
inaccordance withtheprovisions ofChapterVofDirective 75/319/EEC
moredifficult,newcasesforrefusalofauthorization tomarketare
proposedinArticle1(2)and(3):changesincomposition mustbejustified
therapeutically ,changesofnamemustbeforlegitimate reasonsandmust'
notcauseanyriskofconfusionorleadtomistakesastothequalities
I
orproperties oftheproduct.
Afterthepersonresponsible formarketing hasbeenregistered,the
authorities muststillbeabletocheckatanytimeandascertainwhether
theimportedmedicineisinconformity withtheparticulars showninthe
file.Inthecaseofproductsimportedbythemanufacturer ortheapproved
importer,thisconformityisprovedbythecontrolreportssignedbythe
qualifiedperson,whichaccompanytheproduct.Inthecaseofproducts
importedinparallel,othermethodsofproofareprovidedforin
Article1(2)atthediscretionofthepersonresponsible formarketing.

:THECOUNCIL OFTHEEUROPEAN COMMUNITIES ,
Having regard totheTreaty establishing theEuropean Economic Community ,
andinparticular Article 100thereof ,
Having regard totheproposal from theCommission ,
iHaving regard totheopinion oftheEuropean Parliament ,
! . . , j•'
•• - c < '
:Having regard totheopinion oftheEconomic and Social Committee ,
1Whereas Article 4ofCouncil Directive 65/65/^EC asamended
2by .Directive 75/319/EEC provides that in ,order
toobtain marketing authorization theperson responsible formarketing
1shall make anapplication tothecompetent authority oftheMember State
concerned ;whereas Article 22ofDirective 75/319/EEC asamended by
Directive 78/420/EEC-"*makes exemption from controls subject tothe
presentation ofcontrol reports signed bythequalified person ;
■Whereas itis "advisable toprevent the manufacturer from being able to
monopolize theimportation andmarketing ofproprietary medicinal product
|bymerely refusing toproduce -thedocuments relating totheproprietary
product ingeneral ortoaspecific batch ofthat proprietary product ;
Whereas itisconsequently necessary tosupplement theprovisions of
Directive 65/65/EECto-allow theregistration ofparallel importers as
persons responsible formarketing ,which isnecessary fortheproper
supervision ofthemarket bythecompetent authorities ;whereas ,inorder
toavoid purely formal changes inproprietary medicinal products ,itis
also advisable toprovide fornewcases ofrefusal ofmarketing
authorization ; . '
•••/«
'■0JN°22,9February 1965 ,p.369/65
:20JN°L147,9June 1975,p.13
0JN°L123, .11May 1978 ,p.26

-4-
WhereasitisnecessarytoamendtheprovisionsofDirective75/319/EECto
facilitateproofoftheconformityoftheimportedproprietaryproductwith
theparticulars showninthefile,
HASADOPTEDTHISDIRECTIVE :
Article 1
Directive 65/65/EECshallbeamendedasfollows:
1.Point11ofthesecondparagraphofArticle .4shallbereplacedbythe
following :
"11.Anauthorization obtainedinanotherMemberStateorinanon-member
countrytoplacetherelevantproprietary medicinalproductonthe
market,providedthatsuchauthorization exists,withspecification
ofthechangesmadetothisproprietary productinthevarious
MemberStatesandtheparticulars anddocumentsconcerning such
changes."
2.ThefollowingtwoparagraphsshallbeaddedtoArticle4:
"Theholderofthemarketingauthorization shallforthwithcommunicate
tothecompetentauthorities anynewfactorwhichinvolvesachange
intheparticulars anddocumentslistedinthesecondparagraphnn
additionalinstruction,apdinparticular anyprohibiten orrestriction
laiddownbythecompetentauthorities oftheStateswherethemedicine
ismarketed.
Theholderofthemarketingauthorization shallforthwith communicate
tothecompetentauthorities anyamendmentwhichheproposestomaketo
theparticulars anddocumentslistedinthesecondparagraph."
3.ThefirstparagraphofArticle5shallbereplacedbythefollowing :
"Theauthorization providedforinArticle3shallberefusedif,after
verification oftheparticulars anddocumentslistedinArticle4,it
provesthattheproprietary medicinalproductisharmfulinthe
normalconditionsofuse,orthatitstherapeutic efficacyislacking
orisinsufficiently substantiated bytheapplicant,orthatits
qualitative orquantitative composition isnotasdeclared,orthat
.thequalitative orquantitative composition oftheproprietary product
hasbeenchanged,withouttherapeuticjustification ,comparedwith
thatauthorized inanotherMemberState."

ThefollowingthirdparagraphshallbeaddedtoArticle5:
"Lastly,marketingauthorization shallberefusedifthenameofthe
proprietary productriskscausingconfusionwithaproprietary product
whichhasalreadybeenregistered andwhichhasadifferentqualitative'
composition asfarastheactiveprinciples areconcerned,orifthe
nameoftheproprietary productisliabletoinducemisunderstandings
■■i
astoitsqualities onproperties,orif1thenamerequestedisdifferent
fromthatusedintheotherMemberStatesforthesameproprietary ■
product,unlesslegitimate reasonsjustifytheuseof.suchdifferent ;
name." 1•
ThefollowingArticles10aand10bshallbeinsertedafterArticle10:
"Article10a
Thecompetentauthorities shallregistertheother ,personsresponsible
formarketing whosorequest,within45daysofsuchrequest,except
wheretheproprietary producttheywishtoplaceOnthemarketisnot
authorizedintheMemberStatefromwhichitcomesorifithasnotbeenmanu
facturedbythesamemanufacturer orthesamegroupofmanufacturers or
if,incomparisonwiththeauthorizedproprietary product,itpresents ;
differences whichaffectitstherapeutic effectorharmfulness .
Thefollowingparticulars shallbeappendedtothisrequest:
1.Nameorbusinessnameandaddressofthepersonresponsible
forplacingtheproduct .onthemarket, j
- ■"j' ••\ '
2.MemberStatefromwhichtheproprietary producttobeimportedcomes
"•-_ ..-I
3.Nameoftheproprietary productintheMemberStatefromwhichit
-comesandnumberofthemarketingauthorization , !
4.Nameoftheproprietary productintheMemberStatetowhichthe I
application forregistration isaddressed andnumberofthemarketing
authorization , ;v !
), .·.,):
5.Pharmaceutical form. f

Article10b
Thecompetentauthoritiesshallcanceltheregistration providedforin
Article10awhereitappearsthattheproprietarymedicinalproductin
;questionnolongersatisfiestheconditionsreferredtointhatArticle.1
|6.ThefirstsentneceofthefirstparagraphofArticle12shallbe
7 ireplacedbythefollowing:
I"AlldecisionstakenpursuanttoArticles5,6,10a,10band11shall
tstateindetailthereasonsonwhichtheyarebased."■
|Article2
.
.ThefollowingArticle22ashallbeinsertedafterArticle22of
!Directive75/319/EEC: .
Article22a
1.WherethepersonresponsibleformarketingpursuanttoArticle
10adoesnothavethecontrolreportsreferredtointhesecondsub­
paragraphofArticle22(1),hemayrequirefromthecompetentauthorities
(a)thatthecontrolreportsbesuppliedtohim; j
(b)thatthecontrolsdeterminedbythecompetentauthoritiesinj
accordancewiththeprovisionsofthisChapterbecarriedout;\
(c)thatthecontrolsbecarriedoutbyalaboratorydesignatedfor;
■
thispurposebythecompetentauthorities.' \
2.MemberStatesshalladoptallappropriateprovisionstoensurethatI-
themanufacturer suppliesthemforthwith,uponrequest,withthe
controlreportsreferredtoinparagraph 1
foranybatchorpartofabatchofproprietaryproducts ,

3.Uponrequest,thecompetentauthorities concernedshallforthwith
communicatetoeachotherthecontrolreportsreferredtoin
ι
paragraph 1." * i
Article3 | '
MemberStatesshallbringintoforcetheprovisionsnecessaryinorderto.
complywiththisDirectivewithinsixmonthsofitsnotification andshall 1
forthwithinformtheCommissionthereof. v .*."
MemberStatesshallcommunicatetotheCommissionthetextoftheprovisions
ofnationallawwhichtheyadoptinthefieldcoveredbythisDirective.
I .. !
• ■v ' .• • • -r
Artiele4.'-- .1 !'
ThisDirectiveisaddressedtotheMemberStates.. J