ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(76)683
Vol.1976/0205

Disclaimer
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(JOL243du27.9.2003,p.1),cedossierestouvertaupublic.Lecaséchéant,lesdocuments
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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(76)683 final
Brussels.22December1976
COMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
DraftRulesofProcédure
C0M(76)683final

Fxplanatory mémorandum
ByCouncilDirective 75/319/TECof20Fay1975aCommittee onProprietary
f.edicinalProductswassetupwiththemaintasktodiscussconcretecases
regardingauthorization ofproprietary medicinalproducts.
IntheDirectiveitisstatedthattheCommitteeshalldrawupitsown
RulesofProcedt-re.TheCounciladoptedatthesametirceastheIMrective
edeclaration accordingtowhich"theCommission s!iallsi/bmittothe
CouncilthedraftRulesofProcedure.Subjecttotheobservationitmay
formulate,theCounciltakesnoticecfthedraft,theadoptionofwhich
isagreedtobytheComissiori andtheMemberStates"(doc.643/75
(RP/CRS16)of?CJuly197S).|
TheattacheddraftRulesofProcedurehavebeenagreedtobytherepre­
sentatives ofthef-ienberStatesintheCommittee.

DraftRulesofProcédure
ofthe
CommitteeforProprietary MedicinalProducts
HIECOMMITTEER)RPROPRIETARY MEDICINAL PRODUCTS,
HavingregardtoCouncilDireotive75/319/EBCof20May1975ontheapproxi­
mationofprovisionslaiddown"bylaw,regulationoradministrative action
relatingtoproprietarymedicinalproducts(1),andinparticularArticle8(3)
thereof,
HAS UPITSRULESOPPROCEDURE AGFOLLOWS:
•••/•••
1OJN°I147,9.6.75/P-

Article1
1.TheCommitteeshallconsistofonerepresentative foreachMemberState
andonerepresentative oftheCommission.Onealternateshallbeappointed
foreachoftherepresentatives .
2«TheCommitteemembersandthealternatesshallbeappointedbytheMember
Statesforthreeyearsprovidedtheycontinuetobenationalofficials
responsibleforexaminingapplications forauthorization tomarketproprietary
medicinalproducts.Theirappointments shallberenewable.
3.Analternateshallsit'assuch 'ontheCommitteeonlyifthefull
memberisabsentorisunabletodischargehisduties.
4.Eachrepresentative maybeaccompaniedatCommitteemeetings
bynotmorethanthreeeverts.
5.Evenaftertheirdutieshaveceased,members,alternatesandexpertsshall
berequirednottodiscloseinformationofthekindCoveredbytheobliga­
tionofprofessional seorecy.
Article2'
TheCommitteeshallelectitsChairmanfromamongitsmembersbyabsolute
majorityandsecretballot.If,aftertwoballots,nocandidatehasobtainedan
absolutemajorityofthevotes,thememberwhoobtainstherelativemajority
atthethirdballotshallbeelected.Intheeventofatietheoldeetcandidate
shallbedeclaredelected. ^ ■ >
/ .»
Article3
ThetermofofficeoftheChairmanshallbethreeyears.Heshallbeeligible
forre-election onceonly.

t
Articlo4"
i ■ ■ •
Ontakinguphij^duties,theChairmanshallceasetobearepresen­
tativeandshallbereplacedin"thatcapacity*
%
Articlo5
TwoDeputyChairmenshallheappointedtoreplacetheChairmanwhenheis
absentorunit.letodischargehisduties®Oneshall "beelected "bytheCommittee
andtheotherappointed "bytheCommission,
.
TheprovisionsofArticles2and3oftheseRulesofProcedureshallapplyto
theelectionandtheterraofofficeoftheelectedDeputyChairman.
Article6
TheCommitteeshallbeconvenedbyitsChairman,eitheronhisowninitiative
orattherequestofamember# •
Article7
TheChairmanshalldrawuptheagenda,whichshalldistinguish
betveon:
(a)objectionstoapplicationsformarketingauthorizations submittedtothe
CommitteeforanopinionunderArticle11(l)ofDirective7f/3l9/EEC{
(b)rofus.-als,suspensionsorrevocationsofmarketingauthorizations submitted
to-IheCoirisitfceeforanOpinionunderArticle12(2)ofDirective7^319/EBCj
(c)freshexanirmtionsofpreviousopinionsunder 1Article13ofDirective
7V-.19/HIIX'Î. ...
::: «.
(d)rpocific ;casess.«iibmittedtraderArticle14ofDirective7^/319/EEC.

Article8
RequeststoconvenetheCommitteewhicharemadebyamembershallbedrawnup
inaccordancewiththeclassification inthej,foregoingArticleand
reasonedso'thattheymayconstitutetheworkingpaperoftheCommittee.
Articley
1«FursiwnttoArticle9(l)ofDirective15/^9/EEC,theMemberStatecon­
cernedshallforwardtotheCommitteeadossiercontaining s
(a)acopyoftherequestforforwardingtotheCompetentauthoritiesof
thr*IlemberStatesspecified;
(b)c.copyofthemarketingauthorization ;
(c)thoparticularsanddocumentsspecifiedinthesecondparagraphofArticle
4ofDirective65/65/EEC.
ThereshallbeforwardedasmanydossiersasthereareMemberStates
specified,plusoneforthesecretariatoftheCommittee ,,
2»PursuanttoArticle9(2)ofDirective75/319/ESC»theCommitteeshall
forthwithforwardthisdossiertothecompetentauthoritiesoftheMember
Statesspecified,
3.TheCommitteeshallforwardtotheoftheCoraiatt^ethddccGments
referredtoinparagraph1(a)andOb).
Article10
loTheparticulars anddocumentsreferredtoinpoints(1)to(7)and(9)to(11)of
thesecondparagraphofArticle4ofDirective65/65/EECshallbeprovided
intheofficiallanguageoroneoftheofficiallanguagesofeachoftheMember
Statesspecified.Theparticulars anddocumentsreferredtoinpoint(8)ofthe
secondparaaraphofArticle4ofthesaidDirectivemaybeprovidesinalanguage
acceptabletotheMemberStatespecified.

-5«
2.Theparticulars anddocuments specified inthesecond paragraph ofArticle 4
ofDirective 65/65/EECandintended tobepreserved bythesecretariat of
theCommittee shall beprovided inalanguage acceptable totheCommittee .
3®TIiad.-s3io J:4preserved bythesecretariat oftheCommittee maybeconsulted
"byanymember oftheCommittee orbytheexperts referred toinArticle
1(4)with thewritten authority ofthemember .
Article 11
1.Thenotice convening themeeting ,theagenda andtheworking papers shall
beforwarded bytheChairman tothemembers oftheCommittee inaccordance
with theprrcrdv-rs laid down inArticle 18(2)and (3),
2.These papers shall bedrawn upinalanguage acceptable totheCommitted .
3*These papers shall bedslivered tothePermanent Representatives ofthe
Member States andtotheCommission notlater than fifteen days before
the d-.t'a' of -'.hemeeting .
/
4®Inurgent cases ,theChsiraan may,attherequest ofamember ofthe
Committee oron'hisowninitiative ,shorten thisperiod ofnotice byup
.tothree clear working days ,stating thegrounds forhisdecision .
Article 12
1.There shall beaquorum atmeetings ofthe'Committee ifsixMember States are
represented .
2.TheropreseniatiTO pfaMember State may,ifnecessary ,actasthe '
representative ofoneother Member State .TheChairman oftheCommittee
shal lbeinformed accordingly "bythePerKanent Representative ofthe
Member State who istobesorepresented . .-
»ê#/#o«

-6-
Article 13
TheCommittee may setuppanels ofexperts toBtudy matters ofcommon
interest «
Thesecretarial services fortheCommittee shall beprovided bytheCommission ^
assisted ,ifnecessary ,byexperts .
Article 15
•1#TheMember States concerned shall beinformed forthwith ofthereasoned opinions ,
delivered under Articles 11and12ofDirective 75/319/^®^™
accordance with theprocedure setoutinthefirst subparagraph ofArticle
,18(2).
2.Minutes shall beprepared under theresponsibi lity oftheChairman .
foreach meeting ;they shall beforwarded tothemembers oftheCommittoe
inaccordance with theprocedure setoutinArtiole 18(2)and(3).Any
comments which themembers maywish tomake shall becommunicated tothe
Chairman inwriting .TheChairman shall pass them ontotheCommittee j
ifthere isdisagreement }theproposed amendment shall bediscussed at
thefollowing meeting .Ifdisagreement persists ,this amendment shall be
appended totherelevant minutes .
Article 16
TheChairman oftheCommittee shall act onbehalf oftheCommittee forthepurpose
ofmaking the formal record referred toinArticle 10 (1)ofDirective 75/319/EEC .
Heshall forthwith inform the ,Member States concerned ofsuch formal record
inaccordance with theprocedure setout inthefirst subparagraph of
Article 18(2)« .
•••/C

Article17
1»ThesecretariatoftheCommitteeshallactonbehaljfoftheCommitteeforthePUTDOS
offorwardingthedossierreferredtoinArticle9(2)tothecompetentauthori­
tiesni*t.v.slOTharStagesinaccordancewith"theproceduresetoutinthe
firstsubparagraphofArticle18(2)and,forthepurposeofforwardingthedocument
x-etarrodtoinArticle9(3). ,
2.AnyinformationforwardedtotheCommitteeinaccordancewithArticles
11(3)f12Mand33ofDirective75/319/EECshallbebroughttothe
knowledf^of"theff'-itnbersoftheCommitteebythesecretariatinaccordance
withtheproooSuresetoutinthesecondsubparagraph ofArticle18(2).
Article18
1„Correspondence concerningtheCommitteeshallbeaddressedtothesecretariat
oftheCommittee,Directorate-GeneralfortheInternalMarket,forthe
attentionoftheChairrnan.
2.Cor^cnior^taice intendedfortherepresentatives oftheMemberStatesshall
beadireese&tothePermanentRepresentatives .
Copiesofsuchcorrespondence shallbeaddresseddirectlytotherepresen­
tativesoftheMemberStates.
3.Correspondence intendedfortherepresentativeoftheCommissionshallbe
addros.^el*0theCoranission,Directorate-General fortheInternalMarket.
Article19
Notwithstanding Article214oftheTreatyVtheworkofthe ~~"*,
Committeeandofthepanelsofexpertsandallthedocumentssubmittedtothem
shallbetreatedasconfidential.Nevertheless ftherepresentatives ofthe '
Membor3+art03may,inaccordancewiththenationallawsinforce,informthe
personro.:-norisibleformarketingamedicinalproductorproductsofthe *
reasonedobject:onofaJTamber "Stat®,asreferredtoinArtiole10(2)of
Directive75/319£ec*

FinanciatTocoroSheet
TheCommitteecnProprietary ;IccicinaIProductsinccnpGsedfcyrepresen­
tativesoftheMembrrStatesandcftheCommission.
t
TheCommitteewiltmeetinthefollowingcases:
»•whenitiswantedtorarkettheproductinatleastfiveMemberStates
otherthanthefirstfierherStatehevinpauthorizedtheproduct
-wh<9nMemberStateshavetafcerdifferentdecisionsregardingthesame
product
-Wheninspecificc«ses»BerberSt£to££skfofthsopinionoftheCommittee
beforereachingedecisionconcerningararketinr ;authorization
Itisnatpossibletopredict«nythingenactaboutthefr^ouencyofthe
meetings'O'ftheiommittejebeceuscit^epentfscnmanufacturers andMer.ber
!StatestowhatextenttheComityttee-procecurc uiltbeuser!.However,taking
intoaccountthetime-limits whichshatlbefollowedfcytheCommitter ?when
acaseisbroughtfcrit?itwgultfberecscrabtetoestimatetheannual
i. %numberofmeetingstotwelve.EveryNenfctrStatemajsenc?adeleaation .
with4Members^cfinistf^tor^fne.analyst*civ>pherfrfltoto&ist «nd».
oneclinician)t<vlUtS'n^tinos^Thi:ykillGnlybopa1£ifi*.tfav^U*costsf--.--r -.*
fromthecommission.* ■•
Underthementioned -suppositions thecostsfcrtheCcmrcis&tonwillbe
around2$0.0G0FB.pernotingofenr.uaIly$»t)Dp.0G€Fts.•