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DOCUMENTS "COM"
COM(82)198
Vol.1982/0061

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(82)198 final
Brussels.23April1982
Recommendation fora
COUNCILDECISION
approvingadraftAdditionalProtocoltotheEuropeanAgreementon
theExchangeofTherapeutic SubstancesofHumanOrigin
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(submittedtotheCouncilbytheCommission)
C0MC82)198final

COMyiiE
EXPLANATORYMEMORANDUM
ByitsDecisionof253une1979theCouncilauthorizedtheCommissionto
conductnegotiationswithintheframeworkoftheCouncilofEuropewiththe
objectof.addingtotheEuropeanAgreement ,ontheExchangeofTherapeutic
SubstancesofHumanOriginaProtocolwhichwouldenabletheEuropean
EconomicCommunitytobecomeaContractingPartytothisAgreement.
BehindthisDecisionwasthefactthatArticle5(1)oftheEuropean
AgreementontheExchangeofTherapeuticSubstancesofHumanOrigin
specifiesthat'TheContractingPartiesshalltakeallthenecessarymeasures
toexemptfromallImportdutiesthetherapeuticsubstancesofhumanorigin
putattheirdisposalbytheotherParties',OnlytheCommunityiscompetent
tograntderogationsfromtheapplicationofCommonCustomsTariff
duties.
Negotiations betweentheCommission andtheSecretariat-General ofthe
CouncilofEuropehaveresultedinadraftAdditionalProtocolwhichhas
beenconceivedasanintegralpartoftheAgreementandwhichwiiienable
theEuropeanEconomicCommunitytobecomeaContractingPartytothe
Agreementbysigningit.
OnceithasreceivedthepriorapprovaloftheCouncilofMinistersofthe
EEC,theSecretariat-Genera IoftheCouncilofEuropewillsubmitthisdraft
AdditionalProtocoltotheCommitteeofMinistersofthatbody.Itwould
liketobeabietodosoduringameetingtobeheldIrsMayofthisyear.
WhentheCommitteeofMinistersoftheCouncilofEuropehasdecidedto
addthisProtocoltotheAgreement,theEuropeanCommunitywill,beable
tobecomeaContractingPartytothelatter,

-2-
Consequently ,theCommissionrecommendstheCounciltoapprovethedraft
AdditionalProtocoltotheEuropeanAgreementontheExchangeof
TherapeuticSubstancesofHumanOriginandtoauthorizetheCommission
tonotifytheSecretariat-General oftheCouncilofEuropeofsuch
acceptance (Annex1).
WhenthisAdditionalProtocolhasbeenadoptedbytheCommitteeof
MinistersoftheCouncilofEurope(probablyduringthesecondhalfof1984),
theCommissionwillrecommendtheCouncilofMinistersoftheCommunity
toaccedeonthelatter'sbehalftotheEuropeanAgreementontheExchange
ofTherapeuticSubstancesofHumanOrigin.

ANNEXI
Recommendation
foraCouncilDecision
approvingadraft
AdditionalProtocoltotheEuropeanAgreement
ontheExchangeofTherapeuticSubstancesofHumanOrigin,
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropeanEconomic
Community,
HavingregardtotheRecommendation fromtheCommission ,
WhereasArticle5(1)oftheEuropeanAgreementontheExchangeof
TherapeuticSubstancesofHumanOriginJaysdownthatTheContracting
Partiesshalltakeallthenecessarymeasurestoexemptfromallimport
dutiesthetherapeuticsubstancesofhumanoriginplacedattheirdisposalby
theotherParties'?
WhereasonlytheCommunityiscompetenttograntderogationsfromthe
applicationoftheCommonCustomsTariffinrespectofautonomous or
conventionalratesofduty;
WhereastheSecretariat-General oftheCouncilofEuropeproposesto
addtothesaidAgreement anAdditionalProtocolwhichwouldenable
theEuropeanEconomicCommunitytobecomeaContractingPartythereto
andtherebyexerciseitscompetence ?
WhereasthedraftAdditionalProtocolmeetstherequirements
oftheEuropeanEconomicCommunity,

-2-
HASDECIDEDasfollows:
Article1
ThedraftAdditionalProtocoltotheEuropeanAgreementontheExchange
ofTherapeuticSubstancesofHumanOrigin,proposedbytheSecretariat-
GeneraloftheCouncilofEurope,isherebyapprovedonbehalfofthe
Community.
ThetextofthisAdditionalProtocolisannexedtothis
Decision.
Article2
TheCommission shallinformtheSecretariat-General oftheCouncilof
EuropethattheCommunityapprovesthedraftProtocolreferredtoin
Article1.
DoneatBrussels,
FortheCouncil,
ThePresident,

ADDITIONAL PROTOCOL
TOTHEEUROPEAN AGREEMENT
ONTHEEXCHANGE OFTHERAPEUTIC SUBSTANCES OFHUMANORIGIN
ThememberStatesoftheCouncilofEurope,ContractingPartiestothe
EuropeanAgreementof13December1953ontheexchangeoftherapeutic
substancesofhumanorigin(hereinaftercalled"theAgreement"),
HavingregardtotheprovisionsofArticle5,paragraphI,oftheAgreement,
accordingtowhich"TheContractingPartiesshalltakeallthenecessary
measurestoexemptfromallimportdutiesthetherapeuticsubstancesof
humanoriginplacedattheirdisposalbytheotherParties";
ConsideringthatsofarasthememberStatesoftheEuropeanEconomic
Communityareconcerned,theundertakingtograntthisexemptionfalis
withinthecompetenceoftheCommunity ,,whichpossessesthenecessary
powersinthisrespectbyvirtueoftheTreatywhichestablishedits
Consideringthereforethatforthepurposeoftheimplementation ofArticle
5,paragraphI,oftheAgreement,itIsnecessaryfortheEuropeanEconomic
CommunitytobeabletobecomeaContractingPartytotheAgreement,
Haveagreedasfollows?
Article1
TheEuropeanEconomicCommunitymaybecomeaContractingPartytothe
Agreementbysigningit.InrespectoftheCommunity,theAgreementshall
enterintoforceonthefirstdayofthemonthfollowingsuchsignature­

-2-
Article2
1.ThisAdditionalProtocolshallbeopenforacceptance bythe
ContractingPartiestotheAgreement.Itshallenterintoforceonthe
firstdayofthemonthfollowingthedateonwhichthelastofthe
ContractingPartieshasdepositeditsinstrumentofacceptancewith
theSecretaryGeneraloftheCouncilofEurope.
2.However,thisAdditionalProtocolshallenterintoforceonthe
expirationofaperiodoftwoyearsfromthedateonwhichithasbeen
openedforacceptance,unlessoneoftheContractingPartieshas
notifiedanobjectiontotheentryintoforce.Ifsuchanobjectionhas
beennotified,paragraph 1ofthisArticleshallapply.
Article3
i
Fromthedateofitsentryintoforce,thisAdditionalProtocolshallforman
integralpartoftheAgreement.Fromthatdate,noStatemaybecomea
ContractingPartytotheAgreementwithoutatthesametimebecominga
ContractingPartytotheAdditionalProtocol.
Article4
TheSecretaryGeneraloftheCouncilofEuropeshallnotifytheMember
StatesoftheCouncilofEurope,anyStatehavingaccededtotheAgreement
andtheEuropeanEconomicCommunityofanyacceptanceorobjections
madeunderArticle2andofthedateofentryintoforceofthisAdditional
ProtocolinaccordancewithArticle2.
DoneatStrasbourg,the ,inEnglishandFrench,bothtextsbeing
equallyauthentic,inasingleoriginalwhichshallbedepositedinthearchives
oftheCouncilofEurope.TheSecretaryGeneraloftheCouncilofEurope
shalltransmitcertifiedcopiestoeachmemberStateoftheCouncilof
Europe,toanyStateinvitedtoaccedetotheAgreementandtotheEuropean
EconomicCommunity.