ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(77)358
Vol.1977/0118

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(77)358final.
Brussels.22July1977
PROPOSAL FOR ACOUNCIL DIRECTIVE .
amendingtheDirectiveof20May197575/319/EEContheapproximation
ofprovisionslaiddown"bylaw,regulationoradministrative action
relatingtoproprietarymedicinalproducts
(submittedtotheCouncil "bytheCommission)
COM(77)358final

t
1.InArt.9and10ofDirective75/319/EECof20May1975onthe
approximation ofprovisionslaiddownbylawfregulationor
administrative actionrelatingtoproprietarymedicinalproducts
(O.J.L147of9June1975)itisstatedthataMemberStatewhich
hasissuedamarketingauthorization foraproprietarymedicinal
productshallforwardtotheCommitteeacopyoftheauthorization
togetherwiththedocumentation materialifthepersonresponsible
formarketinghasrequiredtoapplyformarketingauthorization
fortheproductinatleastfiveotherMemberStatesthroughthe
Committeeprocedure.TheCommitteeshallhereafterwithoutdelay
retransmitthedossierstotheMemberStatesspecifiedwhichtrans­
missionshallbedeemedequivalenttoaformalapplicationfor
-marketingauthorization .
2.Duringthediscussions ontheRulesofProcedurewithintheCommittee
ithasbecomeclearthattheobligationthatthedossiersinall
casesshallpassthroughtheCommitteeinsteadofbeingsentdirectly
totheMemberStatesconcerned ,willgiverisetosevereadministrative
problemsfortheSecretariati.'and bevery,timeconsumingasthedossiers
areoftenveryvoluminous.Inadditiontothis,theSecretariat of
theCommitteewillnotcarryoutanyexaminationofthedossiersbefore
thetransmission totheMemberStates.
3.Itisthereforeproposed(seeannex)toamendArt.9and10ofDirective
75/319/EECsothatthedossierswillbeforwardeddirectlytothe
MemberStatesspecifiedbytheMemberStatewhichhasalreadygranted
themarketingauthorization .
4«ThePharmaceutical CommitteesetupbyCouncilDecision75/320/EEC
hasagreedinprincipleontheamendmentandthepresenttexthasgot
unanimousapprouvalbyaworkingpartyofnationalexpertson
29JuneI977.

PROPOSAL FORACOUNCILDIRECTIVE
amendingSecondDirective 75/319/EEContheapproximation ofprovisions
LaiddownbyLaw;regulation oradministrative actionrelatingto
proprietary ipedicinalproducts
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishing theEuropeanEconomicCommunity,
andinparticularArticle100thereof,
HavingregardtotheproposalfromtheCommission,
HavingregardtotheOpinionoftheEuropeanParliament (1),
HavingregardtotheOpinionoftheEconomicandSocialCommittee (2),
Whereas,aCommitteeforProprietary MedicinalProductshasbeensetup
bySecondCouncilDirective 75/319/EECof20Mai1975(3)withthe
responsibility togiveanopinionastowhetheraparticularproprietary
medicinalproductcomplieswiththerequirements setoutinCouncilDirective
65/65/EECof26January1965ontheapproximation ofprovisionslaiddown
bylaw,regulationoradministrative actionrelatingtoproprietary medicinal
products(4);
WhereasitisstatedinArticles9and.10ofDirective 75/319/EECthat,
incaseswheretheCommunity-procedure istobeapplied,theMemberState
whichhasissuedthemarketingauthorization shallforwardthedossier
totheCommittee whichshallforthwith forwardthedossiertotheMember
Statesspecifiedbythepersonresponsible formarketing;
Whereasexperience hasshownthattheprovisionthatthedossiersshallpass
throughtheCommitteeinsteadofbeingsentdirectlytotheMemberStates
concernedresultsinadministrative problemsinprocessing thevoluminous
documentation andindelaysintheworkoftheCommittee;
(1)0JNo
(2)0JNo
(3)0JNoL147,9.6.1975,p13
(4)0JNo22,9.2.1965,p369/65

-2-
Whereas ,-jnorder tosolve these problems andtoreduce thedelays itis
'necessary toamend These provisions toenable theHember State which
hasinitially issued themarketing authorization tosend thedossier
directly totheMember States specified aswell astotheCommittee .

HAS ADOPTED THIS DIRECTIVE :
Article 1
Article 9ofDirective 75/319/EECishereby amende 'd
asfollows :
1.TheMember State which hasissued amarketing authorization ,for
aproprietary medicinal product shall forward ,iftheperson
responsible formarketing hasrequested theforwarding toatleast
five other Member States ,adossier containing acopy ofthis
request andacopy oftheauthorization together with theparticulars
anddocuments mentioned inArticle 4»second paragraph ofDirective
65/65/ESCtotheCommittee andtothecompetent authorities ofthe
Member States specified .
2.Suchforwarding shall bedeemed tobeequivalent tosubmitting an
application formarketing authorization ,within themeaning of
Article 4ofDirective 65/65/EEC ,tothesaid authorities®
3.TheCommittee shall forthwith inform theMember States concerned
that thecasehasbeen referred totheCommittee .
Article 2
InArticle 10<<|)0fDirective -75/319/EEC-the words "forwarding referred
toinArticle 9(2)"arehereby replaced by"transmission oftheinformation
referred toinArticle 9(3)".
Article Ï
This Directive isaddressed totheMember States .