ARCHIVES HISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(81)819
Vol.1981/0229

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(81)819final
Brussels/11January 1982
Amendment tothe
Proposal fora
COUNCIL DIRECTIVE
amending Directives 65/65/EEC,75/318/EECand75/319/EEC
ontheapproximation ofprovisions laiddownbylaw,
regulation oradministrative actionrelating to
proprietary medicinal products
A>s^
(submitted "bytheCommission totheCouncilpursuant
toArticle 149/secondparagraph,oftheEECTreaty)
\r"V ^^77YV S*x\7
Vy/':■
C0M(81)819final

Explanatory Memorandum
1.On4December1980,theCommissionputforwardaproposalfora
DirectivetotheCouncilamendingDirectives 65/65/EEC,75/318/EECand
75/319/EEContheapproximation ofprovisionslaiddownbylaw,
regulationoradministrative actionrelatingtoproprietary medicinal
products (OJC355,31.12.1980).
2.InconformitywithArticle100oftheTreatytheEconomicandSocial
CommitteeandtheEuropeanParliamentadoptedanopiniononthe
proposalon29June1981(doc.CES676/81)and16October1981(Doc.
P.E.74.859)respectively .Theseopinionscontainedcertainamendments.
3.TheCommissioniswillingtoacceptcertainoftheseamendments and
proposesthefollowingamendmentstoitsproposal:
-IntheEnglishtext,substitutetheexpression'data-sheet'
for'product-summary' .
-Article1:
paragraph 2,points5.7and5.10
paragraph 5.
-Article2,paragraph2.
-Article3
"Article9,point3
Article13,point1
Article14,point1."

-2~
Amendrr.gnttotheproposalforaCouncilDirectiveamendingDirectives
65/65/EEC,75/318/EECand75/319/EEContheapproximation ofprovisions
laiddownbylaw,regulationoradministrative actionrelatingto
proprietary medicinalproducts
1.IntheEnglishversiontheexpression'data-sheet' whichappearsin
the3rdrecitalaswellasinArticle 1,paragraph 2,2ndsubparagraph,
andparagraph3,2ndand4thsubparagraph,shallbereplacedbythe
expression'product-summary' .
2.Article1,paragraph 2,shallbeamendedasfollows:
5.7Posologyandmethodofadministration forchiIdrenand
adultsrespectively
5.10Effectonabilitytodriveavehicleandoperatemachinery
3.Article 1,paragraph 3,shallbeamendedasfollows:
ThefollowingArticle9ashallbe"InsertedafterArticle9:
"Afteranauthorization hasbeenissued,thepersonresponsible
forplacingtheproductonthemarketmust,inrespectofthe
controlmethodprovidedforinArticle4,point7,takeaccount
oftechnicalandscientificprogressandintroduceanychanges
thatmayberequiredtoenabletheproprietary medicinalproduct
tobecheckedinaccordance withgenerallyrecognizedscientific
methods."
4.Article2,paragraph 2,shallbeamendedasfollows:
InpartI,C,thefollowingparagraph 3shallbeinserted:
"3.Physico-chemical characteristi csliabletoaffectbio-availability
Thefollowingitemsofinformation concerningactiveprinciples,
whetherornotlistedinthepharmacopoeias ,shallbeprovided
aspartofthegeneraldescription oftheactiveprinciples "if
theyrelatetothebio-availability ofthemedicinalproduct:
-crystalline formandsolubilitycoefficients ,
-particlesize,wherenecessaryafterpulverization ,
-stateofhydration,
-oil/waterpartitioncoefficient,
therequirements ofthefirstthreeindentsnotbeingapplicable
tosubstancesusedsolelyinsolution."
./.

-3-
5.Article 3shallbeamended asfollows :
"Article 9
3.TheCommittee shallforwardthisinformation immediately to
theMemberStates.
Article 13
1.Inordertofacilitate anydiscussions bytheCommittee ,the
competent authorities shalldrawupareporttoassessthe
resultsoftheanalytical andtoxico~pharmacologi caItestsand
clinicaltrialsofanyproprietary productcontaining anew
activesubstance whichisthesubjectofanapplication fora
marketing authorization intheMemberStatesconcerned forthe
firsttimeorofanyotherproprietary productthattheymay
choose,particularlywhentheholderofthemarketing authorization
whishestofollowtheprocedure described inArticle 9=
Article 14
1.Whenreference ismadetotheprocedure described inthis
Article,theCommittee shallconsider thematterandexpress a
reasoned opinionwithin60daysofthedateonwhichthematter
wasreferred toit.
Thepersonresponsible forplacing theproduct onthemarket
may,athisrequest ,,explain himself verbally orinwriting
beforetheCommittee expresses itsopinion.Hemayalsoobtain
thesuspension oftheabove-mentioned timelimit."