ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(74)96
Vol.1974/0016

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COMMISSION OFTHEEUitOIEANCOMMUMTES
COM(74)96final
Brussels,4January1974
AmendmenttotheproposalforaCouncilDirectiveontheapproximation
ofthelawsoftheMemberStatesrelatingtoanalytical,pharmaco-
toxicological andclinicalstandardsandprotocolsinrespectofthe
testingofproprietary medicinalproducts
AmendmenttotheproposalforaCouncilDirectiveontheapproximation
ofthelawsoftheMemberStatesrelatingtopublicityforproprietary
medicinalproductsandtopackageleaflets
AmendmenttotheporposalforaCouncilDirectiveontheapproximation
ofthelawsoftheMemberStatesrelatingtomatterwhichmay"beadded
toproprietary medicinalproductsforcolouringpurposes
^Presented "bytheCommissiontotheCouncilpursuantto
thesecondparagraphofArticle149oftheEECTreaty)
C0M(74)96final

EXPLAÎTATORY ÎIEMORAUTOM
Asinothersectors,theproblemarisesinconnectionwithDirectives
concerningmedicinalproductsoftheadaptationofthesetextstotake
accountoftechnicalprogress.
IntheExplanatory MemorandumtotheproposalforaDirectiveonthe
approximation ofthelawsofMemberStatesrelatingto-analytical,
phar.maco-toxicological andclinicalstandardsandprotocolsinrespect
ofthetestingofproprietarymedicinalproducts(Doc.C0M(70)99final),
theCommissionemphasizeditsintentionofpresentingaproposalonthe
matter.Thenationaldelegations ,duringdiscussionofthisproposal
atCouncillevel,askedthatprovisionbemadeforadecision-making
procedureforsuchtechnicaladaptation morerapidthanthatavailable
underArticleICO.
Asimilarproblemarisesinconnectionwiththemeasuresforimplementing
Directives,SomeDirectivesdefineprinciples ,withprovisionforthe
highlytechnicalarrangements forimplementation tobeadoptedatalater
date.ThisistrueoftheproposalfortheDirectiveontheapproximation
ofthelawsoftheMemberStatesrelatingtothematterwhichmaybe
addedtoproprietarymedicinalproductsforcolouringpurposes(O.J.
of28January1967).Article3providesthattheCommissionisto
determine,byaDirective,themethodsofanalysistobeusedforpurity
control.ThesameistrueoftheproposalforaDirectiveontheapprox­
imationofthelawsofMemberStatesrelatingtopublicityforpropriet­
arymedicinalproductsandtopackageleaflets(0,J.of13October1967,
asamendedbyDoc,COM(68)832).UnderArticle12(2)theCommissionmay
amendthelistofdiseasesannexedtotheDirectiveinordertoprevent
self-medication andcommercialabuses,wheresuchpracticesmightendanger
publichealth.

-2-
3.Fortheadaptationoftextstotechnicalprogress,whichmayrequire
greatspeed,andfortheimplementing measures,whicharegenerally
ofahighlytechnicalnature,acommitteeseemsto"bethemostsuitable
instrument.TheprocedurealreadyadoptedinanumberofCouncilDirec­
tivesappearssuitablealsointhisfield.TheCommissionadoptsthe
measuresproposediftheyareapprovedbytheCommittee.IftheCommittee
doesnotagreewiththemeasures,orexpressesnoopinion,theCommission
submitsaproposaltotheCouncil.Thelatterthendecidesbyaqualified
majority;ifwithinacertaintimeithastakennodecision,theCommission
adoptsthemeasuresinitiallyproposed,
4.Althoughtheestablishment ofa"CommitteeonProprietaryI'edicinal
Products"isdiscussedintheproposalforasecondDirectiveon
proprietary medicinalproducts,itdoesnotseemadvisabletoassign
thesenewdutiestoitaswell.Asregardsimplementing measuresand
adaptationtotechnicalprogress,theCommitteewillborequiredto
giveanopinionthatwouldhave'effectsonthedomesticlawsoftheI'!ember
States;itwouldthusbelongtothc/tclassknownas"legislation
committees".UnderthesecondDirectivehowever,itwillbecalledupon
togiveanopiniononindividualapplications formarketingauthorization ,
andthusitsfunctionwouldbemorethat,asitwere,ofa"management
committee".Moreover,ifitspowersaretobesubsequently extended,
asenvisagedinthesecondDirective,itseemswisertopreserveits
independence .
./•

AmendmenttotheproposalforaCouncilDirective
ontheapproximationofthelawsoftheMemberStates
relatingtoanalytical ,pharmaco--toxico1ogica,land
clinicalstandardsandprotocolsinrospoctofthe
testingofproprietary medicinal,products
1.)ThefollowingarticleisinsertedintheproposedDirective:
.Article3
1.AStandingCommitteeforMedicinalProducts(hereinaftercalled"the
Committee")isherebysetup.Itshallconsistofrepresentatives of
theMemberStates,witharepresentative oftheCommissionasChairman.
2.TheCommitteeshalladoptitsownrulesofprocedure.
3.TheCommitteemayexamineanyquestionconcerningthsoperationofthis
DirectiveraisedbyitsChairmaneitheronhisowninitiativeoratthe
requestofarepresentative ofaMemberState.
4.AnyamendmentsneededtoadapttheAnnextothisDirectivetotechnical
progressshallbeadoptedinaccordancewiththeprocedurelaiddown
inparagraph
5.Therepresentative oftheCommissionshallsubmittotheCommitteea
draftofthemeasurestobetaken.TheCommitteeshalldeliveritsopinion
onthisdraftwithinatimeliiaitsetbytheChairmanhavingregardto
theurgencyofthematter.Itshallactbyamajorityofforty-one,the
votesoftheMember.StatesbeingweightedasspecifiedinArticleI4S(2)
oftheEECTreaty.TheChairmanshallnotvote.
6.a)TheCommissionshalladoptthemeasuresenvisagedwheretheyarein
accordancewiththeopinionoftheCommittee.
b)Wherethemeasuresenvisagedarenotinaccordancewiththeopinion
oftheCommittee,orifnoopinionisdelivered,theCommissionshall
withoutdelaysubmittotheCouncilaproposalforthemeasurestobe
adopted.TheCouncilshallactbyaqualifiedmajority.

c)Ifwithinthreemonthsoftheproposalfeeingsubmitted ,toitthe
Councilhasnotacted}themeasuresproposed ,shallbeadoptedby
theCommission.
2.)TheformerArticles3and4shallbecomeArticles4and.5»

AmendmenttotheproposalforaCouncilDirective
ontheapproximationofthelawsoftheMember .States
relatingtopublicityfor'proprietary medicinalproducts
andtopackageleaflets
ThesecondparagraphofArticle12isreplaced "bythefollowing:
"ThelistofdiseasessetoutintheAnnexreferredtointhefirst
paragraphmaybeamendedforthepurposeofpreventing an3rsuchself-
medicationorcommercialabusesasmightendangerpublichealth.Such
amendmentsshallbeadoptedundertheprocedurelaiddowninArticle3
paragraph5and6oftheCouncilDirectiveof onanalytical,
pharmaco-toxico logicalandclinicalstandardsandprotocolsinrespect
ofthetestingofproprietary medicinalproducts.
TheCommitteereferredtoinArticle3oftheaforecitedDirectivemay
examineanyquestionconcerningtheoperationofthisDirectiveraisedby
itsChairmaneitheronhisowninitiativeorattherequestofarepresen­
tativeofaMemberState."

AmendmenttotheproposalforaCouncilDirectiveonthe
approximation ofthelawsoftheIlomherStatesrelating
tonatterwhichmayheaddedtoprorrletarymedicinalproducts
forcolouringpurposes
Article3oftheproposedDirectiveisreplaced "bythefollowing :
"Article3
Themethodsofanalysisto"beusedforpuritycontrolinaccordancewith
thestandardslaiddowninAnnexIIIshall "beadoptedundertheprocedure
laiddowninArticle3»paragraph5and-6oftheCouncilDirectiveof
........... onanalytical ,pharmaco-toxicological andclinicalstandards
andprotocolsinrespectofthetestingofproprietary medicinalproducts.
TheCommitteereferredtoinArticle3oftheaforecitedDirectivemay
examineanyquestionconcerningtheoperationofthisDirectiveraised
"byitsChairmaneitheronhisowninitiativeorattherequestofa
representative ofailernberState."