ARCHIVES HISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(81)363
Vol.1981/0113

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(81)363 final
Brussels .13th July 1981
THIRD COMMISSION REPORT TOTHE COUNCIL
ONTHE FUNCTIONING OFTHE COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
·,.· ■■■.;■::»3-" I
I
V ->> , V/\s>..V' .'V''/
COM (81)363 final

•ThirdCommission reporttotheCouncil
onthefunctioning oftheCommitteeforProprietary Med?cineI-Products
î.INTRODUCTION . ■-
1.,CouncilDirective 75/319/.EECestablishing t;ieCcinm^ttteforProprle --
taryMedicinalProductsprovided ,,inArticle 15<-1),thatthe'Cornmi.ssion'
shouldreporttotheCouncil -annuallyon'theoperationofthatCommittee' s
procedureanditsImpactionthedevelopment -ofi.ntra-'Communitytrade.
Essentially ,t'*<eCommittee' sprocedure makes -it•possibleforthe
holderof-amarketingauthorization inoneMembefState .-tofileanapplication
forauthorization inrespectoftb.e'game'proprietary productinatleastfive
othercountries .Shouldoneormorecountriesconsiderthatsuchauthorization
cannotbegranted,theobjections aresubmittedtotheCommittee,which
î /
expresses anon-binding opinion .,
2.TheCommittee' ssetting-up andrunning-inperiod,in1977and1978,
wasthesubjectofaninitialreport. I•
4VDuring1979,theperiodcoveredbytheSecondReport',theCommittee
ι
meetingswerethemeansofpromoting ,cooperation betweenthenationalauthori­
ties,especiallyinthefieldof-drugmonitoring .Simultaneously ,the-
-Committee'sthreegroupsofexperts ^werepursuingtheirworkonv'thesafety
andefficacyofmedicines andonplant-based products.
Nevertheless ,bytheendof1979,theprocedure hadbeen-usedonly
twice,withtwoCommitteeopinionsemerging. . -
3.'ThisThirdReportcoverstheyear1.980andthefirsthalfof1981.
/ '
Anincreasing numberofapplications involvingtheuseofthe
Committee'sprocedurewerefiledfromthesecondhalfof1980,butthe
vastmajorityofthe.opinionswerenotadopteduntil1931r
; * „/.
*0JN°L147,9.6.75
4>
-C0M(79)59,22.2.79 -
îAr4k4r *■
C0MC80)149,31.3.80

owingtothenormaleffectoftheperiodsallowedfortheprocedure ,,
Itwastherefore advisable towaituntil1931,,soastohaveaminimum
amountofexperience withthis.procedure andbeabletoarriveatafirst
assessment ofitsfunctioning .Bytheendof1980,-,theCommission had
alreadysuppliedinformation onthestatus'cftheCommittee'sprocedure
anditsinadequacies initsreport*totheCouncilontheapproximation
cflaw%relating -toproprietary medicinal products ,,Thisreportsupported
proposals therosinpurposecfwhichistosecuremutualrecognition of
marketing authorizations ^inparticular through achangeintheCommittee's
procedure ./•'
4„Undersuchcircumstances ^assessment oftheprocedure 6sspecific
effectsonthedevelopment cfintrarCemmunity traderemainspurposeless .
Thestatistics concerning thedevelopment ofintra-Community tradein
medicinal products between 1975and1980aresetoutinAnnexI,
*
Intra-Community importsofmedicinal products accountfornearlythree-
quartersoftheCommunity'stotaldrugimports.Itdoesnotappearas
thoughthishighproportion canbeexceeded.A.lmosttwo-thirds ofexports
gotonon-membercountries .Thetradebalanceisinsubstantial surplus ,,
asimportsfromoutsidetheCommunity amounttoscarcely aquarterofthe
volumeofexportstonon-member countries .
COM(80)789 ,28.11.80
Proposal foraCouncilDirective amending Directives 65/65/EEC,75/318/EEC
and75/319/EECandproposal foraCouncil Recommendation concerning tests
relatingtotheplacing onthemarketofproprietary medicinal products/
OJN°C355-31.12.80 .

11*FU;JCTI9NI-NG OFTHEPROCEDURE PROVIDED FORINARTICLES ?-11OF ■
DIRECTIVE75/319/EEC • ",
Variousobservations arecalled''forasaresultofconsideration of
thesuccessive stagesintheprocedureforapplications formarketingauthori­
zation,asprovidedin,Articles 9-11ofDirective 75/319/EEC,whichwere
madebyaMemberState,attherequestof&manufacturer ,toatleastfive
otherMemberStates. /
<
1.FILINGQFAPPLICATIONS
V
»
.'Eachapplication mayrelatetooneormoreproprietary medicinal
productscontaining thesameactivesubstanceinseveralpharmaceutical
ordosageforms. ( -•
Thenumberofapplications filedhasconsiderably increasedsincethe
secondhalfof1980.
Numberofapplications 19781979- r
I·
1980 11980
1sthalf¡2ndhalf
I1981
1sthalfTOTAL
(JUNE1981)
/
Filingofapplications 22I
1'6
»
I5i
16
Numberofproprietary
medicinalproducts523:·»
1
i9 28
Someapplications areaccompanied byvoluminous dataandtheyreachthe
'variouscountriesconcernedonlyaftersomedelay,which,in'twocasesoutof
sixteen,hasexceeded45days.Inordertoreducethisdelay,theCommittee ,has
agreedthattheapplicant canbeinstructed bythecountryoforigintol.odge
himselfacopyofthedossierwiththecountries concerned andtheCommittee's
Secretariat .

-L-
2-'ESfSENtATI0M_0F_TH§_20SSIER
Alltherecentdossiersareinconformity withthepresentation scheme
recommended bytheCommittee.
\ • \
Thisstandardpresentation exemptstheapplicantfromcomplyingwith
thevariousnationalformsofpresentation ,butalso,andinparticular,it
considerably facilitates theCommittee'sproceedings .
Anotherappreciable advantageoftheCommittee'sprocedureisthe
possibility ofemploying languagesotherthanthenationalLanguageforthe
mostvoluminous partsofthescientificliterature .InanoticeofJuly1980
toapplicants,certaincountriesstatedwhichlanguagestheycouldaccept.
Thus,inthecaseofadossierinEnglish,andevenmoreinthatofonein
bothEnglishandFrench,onlythegeneralinformation ontheproduct,the
labelandthepackageinsertwill,asageneralrule,havetobetranslated .,
Thisobviateslong,expensive andpossiblydubioustranslations ofsome
thousandsofpagesofeachdossier.
ACCEPTABLE LANGUAGES.¡
GR
(3)ACCORDING TOTHE
NOTICE 'BEBRDDKFR IRITLUXNLUK
ENGLISH t■·
pharmaceutical
dossier(1)'+ –+ -++ -+ .++
tests(2) +++ -+'+++++
FRENCH-
pharmaceuticalr
dossier(1) + - –+++ -+ ■+ -·
'tests(2) + -+-++ -+++ -
GERMAN -
pharmaceutical•
dossier(1) ++- - + -++ -
tests(2) +++ -+
- -++ -
(1)Pharmaceutical dossier:composition,methodofpreparation andmanufacturer'
controlmethods(Art.4(3),(4),(7),
Directive 65/65/EEC)
(2)Analytical,toxicologicalandpharmacological testsandclinicaltrials
(Art.4(8),Directive 65/65/EEC:
(3)Particulars providedbytheGreekmemberoftheCommittee.
; ./.
OJN°C162,2.7.80

V .-5-
'ht .
3.MEMBEg_STAT|S -INVOLyiO-IN.THE_COMMIXXiI:§.£SS£I2y£I
NewdrugsaregenerallyfirstintroducedintheUnitedKingdom,France
andGermany.TheCommittee'sprocedureisthereforerelativelylittleused
vis-a-visthesethreecountries,whereproprietary productsaregenerally-
alreadybeingmarketedwhentheprocedureisinitiated.Mostoftheapplicar
tionsforwardedtotheCommittee havebeenfiledbytheUnitedKingdom.
Thisispartly -accountedforbythefactthattheoriginalparticulars and
documentsinEnglishcanbeuseddirectlyinmostoftheothercountires.-
Itmaybeobservedthat,whereastheprocedurerequiresthattheapplicant
solicitatleastfiveStates,theaveragenumberhashithertobeenlessthan
six<5.875tobeexact).^ '
Outof16applications
atJune198TBEBRDDKFRGRIRITLUXNLUK.
Numberofapplications
introduced by
thecountry 1* *3130000009
Numberofapplications
madetothecountry12812709101515'6
4.NATI0NAL_EXAMINATIQN 4_WITHIN_12g_DAYS
Assoonasreceiptofanapplication byallthecountriesconcerned has
beenconfirmed,the-Committee'sSecretariat informsthenational'authorities
bytelexofthecommencement oftheprescribed maximumperiodof120daysfor
theexamination of(thefile.Theapplications examinedhithertohaveallbeen
thesubjectofreasonedobjectionswithinthemeaningofArticle10(2)of
Directive 75/319/EEC.Usuallysuchobjections comefromallthecountriesto-
whichtheapplications aresent;thosemadeuponexpiryofthe120-day
time-limitarenottakenintoaccount.Thepledgethatthistime-limitwill'
becompliedwithisanappreciable advantageformanufacturers .
TheCommittee hopesthatinfuturenationalauthorities -wi11make.a
cleardistinction betweenobjectionsofsubstance,whichrequirein-depth
discussion bytheCommittee,andmererequestsforclarification or .
linguistic amendments,whichcanbesatisfiedthroughdirect:contactwith
applicantsbeforetheCommitteeactuallymeets.

5.OPINIONS_OF_THE ÇOMMITTEE
TheCommittee hasnotyetbeeninaposition toinformanyMember
Statethat,asprovided inArticle 10(1)ofDirective 75/319/EEC,whereno
objections havebeennotified,theMAappliedforshouldbegranted.
ByMay1981ithaddelivered elevenopinions withinthe60daysreferred to
inArticle11(1)ofthisDirective,twoofthembeingin1979,twoin1980
andsevensincethebeginning of1981. *
Contrary tothefearsexpressed bythepharmaceutical industry,the
Committee hasnotaggregated thedemandsofallitsmembers.Sofarfrom
this,ithasbeencarefultoassumemoderateattitudes ,securing thewith­
drawalofmanyobjections duringdiscussions .
Sincedialogue betweentheapplicant andtheCommittee hasnotyet
beenprovided forinthecurrentprocedure,thereremainafewanalytical
pointstobeclarified orafewamendments tobemadeinthegeneralinfor­
mationorthepackageinsert.'The'fCommittee mentionsthisinitsopinion
sothatamanufacturer maygiveasingle,comprehensive reply.
Intheinterests ofcompanies concerned ,itisnotpossible toquote
thenamesofthemedicines subjected totheprocedure .Itmaybenoted,
however,thattheCommittee unanimously decidedtoadoptsixfavourable and
twounfavourable opinions .Theunfavourable opinions wereduetoinadequacies
inthefilesasregardsproofoftheharmlessness andefficacy ofthedrugs.
Threeotherfavourable opinions wereadopted bythemajority ofthe
Committee members;one,threeandfourCommittee membersrespectively were
notwhollysatisfied withthedocuments andparticulars submitted .
6.ACTI0N_TAKEN_0N_THE_C0MMITTEEj_S_0PINI0NS
Itismandatory fortheMemberStatestostatetheirpositions within
30daysofreceiving theCpmmittee'sopinion.
Moreoftenthannottheyhave,withinthisshorttime-limit ,onlybeen
abletoinformtheCommittee thattheywerepreparing tocomplywiththe
opinionexpressed .Authorization canthenbegrantedonlywhenthemanufacturer

-7-
hatbeenAbletosubmittheAdditional Information requested bytheCommittee
orwhenhehasagreedtoamendhispackageinsert.
Intheshorttermsthereisnoprospect ofthetextsofnational
packageleaflets beingstandardized ,evenifagreement canbeobtained in
theCommittee onthemainindications orotheressential dataofauthori­
zation.
Inthecase-arareroccurrence -ofaproposal torefuseaproduct,
themanufacturer mustbegiventheopportunity toexhaustallthepossibili­
tiesoffered byappealproceedings atnational level,whichareoften
long-drawn-out.TheCommittee keepsitselfregularly informed ofthesub­
sequentdevelopment oftheprocedure atnational level.TheCommission ,
foritspart,watches,verycloselythisstageoftheimplementation ofthe--
Committee'sopinions inordertopreventunwarranted delays.
TheCommittee hasalsoexpressed thewishthatanysubstantial changes
madeinthefileoncetheproducthasbeenauthorized bebroughttoits
noticeeitherbythemanufacturer orbythenationalauthorities inorder,
asfaraspossible,tokeepajinglefileforeachoftheproprietary products
inrespectofwhichtheCommitteei'sprocedure hasbeenfollowed .

III.COOPERATION WITHIN THECOMMITTEE
1.GENERAL
Cooperation betweenthenational authorities throughtheinstrumenta­
lityoftherepresentatives withintheCommittee forProprietary Medicinal
Products continues tointensify .Amongthesubjectsdealtwitharestreng­
theningoftheinformation exchange system,drugmonitoring ,follow-up of
theworkofthepanelsofexperts,andcertainviewsconcerning the
implementation oftheDirectives .
TheCommittee forProprietary Medicinal Products heldsixmeetings in
1980,namely,on24January,4-5March,2April,13-14May,9September
and11-12November .Duringthefirsthalfof1981theCommittee metthree
times,i.e.,on10-11February,10-11Marchand11-12May. '
Therehavebeensomechangesinthemembership oftheCommittee .
TheDanishrepresentatives arenowMrANDERSEN,member,andMrsKYLLINGSBAEK ,
deputy,whiletheFrenchrepresentatives areMrGRECH,member,and
Professor ALEXANDRE,deputy.Professor STILLEhasbeenappointed theGerman
representative 'sdeputy. (
Greecehasappointed asitsrepresentatives ontheCommittee Professor VAR0N0S
member,andMrsMELISSARATOU ,deputy.
Alistofthepresent membersoftheCommittee isgiveninAnnexII.
2.INFORMATION EXCHANGE SYSTEM
Theexchange ofinformation onmedicines provided forbyDirective
75/319/EEChasincreased .Verysimpleprocedures havebeenintroduced inorder
tooptimizetheuseofthisinformation ,withoutforcingeithergovernment
departments ortheCommission tocreatenewinstruments forthispurpose.
Pursuant toArticle 33ofDirective 75/319/EEC,allnational measures
relatingtomarketing authorizations formedicines mustbebroughttothe
attention oftheCommittee immediately .Thecommonnotification form
(cf.AnnexIII)recommended bytheCommittee hasbeenemployed byall,
MemberStatessinceJuly1980.itenablestheCommittee'ssecretariat

-9-
topassontonationalauthorities themostimportant datareportet bya
MemberState:newdrugs(substance,dosage,newformorindications ),
refusals,casesofprohibition ofaproprietary medicinal productandits
withdrawal fromthemarket.Uptonow,approximately 2000formsofthis
typehavebeensentintotheCommittee,whichhasforwarded about800to
theappropriate government departments .Furthermore ,,thisinformation is
usedbytheCouncilofEuropeforthepurposeofupdatingResolution AP(77)1
ondrugssubjecttomedicalprescription .
«
Alistofnational correspondents (AnnexIV),whichisregularly
updated,hasbeendrawnuptopermitrapidexchangeofaccurate information
inthefollowing fields:
-decisions authorizing marketing (Article 33,Directive 75/319/EEC);
-withdrawal ofbatches,prohibition ofsupply(Article 28,
Directive 75/319/EEC);
-manufacture ,inspection (Article 30,Directive 75/319/EEC);
-drugmonitoring (Articles 12and14,Directive 75/319/EEC).
3.DRUG_M0NIT0RING
Certainmedicines havebeenthesubjectofspecialdiscussion bythe
Committee,whichhasreviewedtheirquality,safetyorefficacy .Without
formallyreferring toArticles 12or14ofDirective 75/319/EEC,Committee
membershaveformedthehabitofraisingtopicalquestions orpresenting
*
measures whichtheirnational authorities contemplate adopting .
Moreparticularly ,thefollowing activeprinciples havebeendealt
with:aristolochid acid;clioquinol ;clomdine ;dicycloverine;dinoprost ;.
(R)dinoprostone ;difemerine furazolidone ;Haemoresin ;lynoestrenol ;
mecfroxyprogesterone ;methapyri lene;nalidixic acid;noramidopyrine ;
oxetorone ;sulfinpyrazone ;tienilicacid;tipepidine ;triazolam ;valproic
acid.Urgentmeasures takenatnational levelcanbeimmediately communicated
tothecorrespondents mentioned above.
./.

-10-
4.ÇOMMITTEE_S_PANELS_0 F_EXPERTS
Pursuant toArticle 13ofitsrulesofprocedure,theCommittee set
upthreepanelsofexpert?.
TheWorkingPartyonMedicinal Products ofPlantOrigin,chairedby
Professor SCHNIEDERS ,hasnotmetsince1979asitisawaiting theresults
ofstudiesbeingcarriedoutatnational level,notablyinGermany.
TheWorkingPartyontheSafetyofDrugs,chaired byDrGRIFFIN,
completed itsworkinDecember 1979anditsproposals havebeenincorporated
intheabovementioned proposal foraCouncil Recommendation of4December 1980.
Nevertheless ,itmeton9June1980torevisetheprojectrelating to
mutagenic potential,whichwillbeformally submitted whentheproposal for
including themutagenesis testinDirective 75/318/EEChasbeenadopted by
theCouncil.
TheWorkingPartyontheEfficacy ofDrugs,chaired byDrDUKES,met
fourtimesin1980,e.e.,on11-12February,21-22April,16-17June
and29-30September andonceduringthefirsthalfof1981,namelyon
22-23June.
Thedraftconcerning fixedcombinations ofdrugshasbeenincorporated inthe
proposal foraRecommendation of4December 1980.
Thestudiesconcerning cardiacglycosides andoralcontraceptives havebeen
completed .Considerable differences ofopinion haveemergedregarding the
clinicaltrialswhichhavetobecarriedoutinthecaseofdrugsintended
foruseinlong-term treatment,suchasnonsteroid anti-inflammatory agents,
antiepileptics andantianginal agents.Thestatusoftheworkofthispanel
ispresented inatable,whichappearsinAnnexV.
Theconsultation procedures arefaradvanced .Themainobjectofthe
workoftheCommittee'sexpertsistotrytoavoid,insomefieldswhich
havepriority,differences intheimplementation bythenationalauthorities
oftheprovisions ofDirective 75/318/EEC,whichrelatetothestandards and.
procedures inrespectofthetestingofmedicines .Thisworkentails avery
onerousconsultation procedure,whichitisadvisable tomentionatthispoint.
Thepriority subjects aredetermined bytheCommittee forProprietary Medicinal
Products byagreement withthePharmaceutical Committee .Thenational
authorities appointtheexpertstheyconsiderbestqualified totakepart
inthework.Duringthestageinwhichtheprojectsarebeingdrawnup,

thesegovernmentexpert*usuallyconsultvariousaxpart4oftheirchoicein
theuniversities orthepharmaceutical industry.Whenaprojectisconsidered
bythepaneltohavemadeadequateprogress/itissubmittedtotheCommittee
forProprietary MedicinalProducts.OncetheCommitteehasprovisionally
acceptedthetextpresented,itforwardsitforcommenttothenational
authorities,who,thenconsultthe.partiesconcernedatnationallevel.
Simultaneously ,theCommission sendstheprojecttotherepresentatives of
theEuropeanpharmaceutical industry.Theobservations obtainedarethen
studiedbythepanelofexpertsoveraperiodofsixtotenmonthsanda
definitivedraftissubmittedtotheCommitteeforProprietary Medicinal
Productsforadoption.TheCommission and,whereappropriate,theCouncil
decideinduecourseupontheactiontobetakenonthesevariousprojects.
•••• '•* / ■'
At3jointmeetingoftheexpertsintheworkingpartiesandexperts
representing theEuropeanpharmaceutical industryon10June1980,acertain
concurrence ofviewsemergedatthetechnicallevel.However,thepharma-'
ceuticalindustryhasonseveraloccasionsregrettedthatithadnotbeen'
•formallyconsulted whentheseprojectswerefirstbeingdrawnup.The'Committee
hasnotyetconsidereditadvisableto;admittheindustry'srepresentatives
totheworkingparties.
* ■. ■ '*
5.C0MMENTS_0N_THE_IMPLEMENTATI0N_0F_THE_DIRECTI VES
Inthecourseofitswork,theCommittee hasbeenfacedwithvarious
questionsraisedbythenationalauthorities duringtheimplementation ofthe
provisionsofDirectives 65/65/EEC,75/318/EECand75/319/EECwhichare
directlyconnectedwiththeexamination ofapplications forauthorization .
Inthefirstinstance,thesereflections conducetomoreuniformimple­
mentationoftheseDirectives .ThusitwasthattheCommitteedefinedits
positionregardingthequestionwhethercertainpreparations possessedthe
characteristics ofmedicinesorproprietary medicinalproducts.^Ithasalso
studiedthenationalrequirements foridentification ofcolouringagentsin
finishedproduct's.Theworkofthepanelsonsafetyandefficacyhasserved
tobringclosertogetherthepointsofviewofthenationalexpertsconcerning
theimplementation ofDirective 75/318/EECasregardspharmacological andtoxi-;
tologicaltestsandclinicaltrials,whilehighlighting thevariousdifferences
ofopinion.Furthermore,thisworkhasgreatlyfacilitated theadoptionofthe
Committee'sopinionsonapplications submittedinaccordancewiththeprocedure
laiddowninArticle9ofDirective 75/319/EEC.
./.

12-
Inthemediumterm,certain comments mayprompttheCommission ,ifit
considersitworth-while ,tomakeproposals for*improving thepresent
Directives ,afterconsulting thePharmaceutical Committee .
Forinstance,itisnoteasytointerpret Article 4<8)ofDirective
65/65/EEC,whichmakesprovision forcertainexemptions concerning thead­
missionoftheresultsofpharmacological andtoxicological testsand
clinicaltrials.Someauthorities acceptanabridged dossierifthedrugis
wellknown.TheCommittee hasenquired aboutthepractices inforceinthe
MemberStatesbecauseithasitselfhadtodefineitsposition whentwo
abridgedapplications submitted inaccordance withitsprocedure havebeen
examined .
Inaddition,theCommittee hastakennoteofpost-marketing-surveiIlance
pilotprojects .Theyconcernclinicaltrialscarriedoutaftermarketing and
intended,inveryspecialcases,toenablethevolumeoftheinitialapplica­
tionfiletobereducedinordernottodeprivepatients fortoolongofa
drugthatisvaluable butexertscertainrareside-effects whichperhaps can
bedetected onlyasaresultofagreatnumberofobservations .
Finally,theCommittee hasacquainted itselfwiththenewproblems
relatingtothetestingofsubstances manufactured bymeansofbioengineering
processes bringing geneticmanipulation techniques intoplay.

ECHANGES INTRA-ETE/TRACOWüNAUTAIRES
(Médicaments ausagehurr;dinetvétcrinai.re,Chapitre3D.C3duT.D.,";)
1.IMPORTATIONS ;,enmillionsd'UCEy-T..p..C.Chapitré30."03..
h–,
Annéed'im­
portation»
FUR.9IDEUT.
ÌFRJII
*1NL1 .i
3-LjUK
ιIREL.
Ir
DK'j
!
1975
%intraCEE1Í2I196
■74%j6'·%'Γ Γ
18-I91'142
83%I72%\'67%
ι 1184
79%i ί I
7932j.40\
59%I90%■j59%
1976
%intraCEE1„034
-.72%■258
62%! 1
•p-¡'n?·ί'iço
C, .,|.,yv"7"7v/i7""/!O~*V((/ftiƒi/cjõfΛ
! I230
77%.107'
-59%■i
42 j
.'87.% j56
60%
1977
%intraCEE1,18?
73%326
63%35!112
8775%■217
84%240
76%143
.65%'9
97%67
64%
1978
%intra·CEE1.447!410
72%j63%Cc1
V j
85%143·■
71■%259
80%277
76%-168
62%,„59
96%'77
.58%,
1979
%intraCEE!,648482
727.I65%65
78%154
72%281·
80%301.
76X'210
■65%71.
96'4'·82
59%
1980*)"
%intraCEE1.849
■72%540-
63'%1Q1
74%132
73%29ó
82%322
75%231
69%87
93%90■
60·%.
2* enmillionsd'UCE,T.D.CaChcpitre30.03
Annéed'ex­
portation■
EUR9•
DEUT.FRITNLB-LUKIREL.DK-
1975 ,
%intraCEE-1.786
33%518
31%344
26%116
27%126
49%171
66%427
23%16
59%.79.
24%
1976
7.intraCEE2.184
337.642
31%407
267.137
34%179
48%'220
65%475/
24%22-
65%'100
24%
1977
7.intraCEE2.551
337..708 ■
287.472
287.172
30%211
51%266
63%'573
24%29
72%120
24Ζ
1978
%intraCEE2.887
367.768
297.546
32:7.175
32%232
52%317·
65%~681
27%34
72%,130
30%
1979
7.intraCEE3.136
377.862
29%649
33%187
33%237
53%334
64Ζ.675'
34%45
71%147
32%
1980*).
%intraCEE3.801
357.992
307.828
297.221
317.278
52%
1......394
59%868
29%49·
69%'171
327.
*)Chiffresprovisoires

ANNEXEII / v' .
LISTEDESMEMiBESDU .^ ••
COMITEDESSPECIALITES PHARMACEUTIQUES
COMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
V -
Président /Chairman :
< • <
M.LéonROBERT '18,rueJ.P.Koenig ■'
L-1865Luxembourg
Tél.:(352)260.76 ;
Vice-Pr£sidents /DeputyChairmen :
1.Prof.DuilioPOGGIOLINI DirettoreGeneraledelServizioFarmaceutico
i MinisterodellaSanità -
2.M.Nicolaas BEL ChefdeDivision àlaDirectiongénérale
duMarchéintérieur etdes
Affairesindustrielles -III/A-3v
Commission des,Communautés européennes
LISTEDESMEMBRES/LIST0FMEMBERS
a)Représentants /Représentatives :
b)Suppléants/Deputies <:
BELGIQUE ... '.•'^"
a)M.BenHUYGHE
b)Mme.DeniseTORFS-BRUDER
DANMARK
a)Mr.HansOttoANDERSENf
b)Mrs.HelgaKYLLINGSBGKInspecteur Général/Inspectiongénérale
delaPharmacie
Ministère delaSantépublique-^
CitéAdministrative,QuartierVésale •
1010Bruxelles
Tél.:564.10.64
Télex:25.798 •
Pharmacien-Inspecteur,
Inspection généraledelaPharmacie
Ministère delaSantépublique .
CitéAdministrative ,QuartierVésale
1010Bruxelles
■Tél.:564.10.64
Télex:25.798 '
Sekr,etariatschef Acand.pharm.. ■ •
Sundhedsstyrelsen ,Farmaceutiske Laboratorium
Frederikssundsvej 378 .^
DK-2700Br0nsh0j
Tél.:02-94.37.73
'Télex:35333IPHARMDK
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Lic.pharm.,Sundhedsstyrelsen ,
Farmaceutiske Laboratorium ,
Frederikssundsvej 378,DK-2700Brtfnshgj

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desBundesgesundheitsamtes
~Stauffenbergstraße 13
.D-1000Berlin30
Tél.:26.37.203resp.204./Télex:183310
b)ProfDr.-GynterSTILLE DirektorundProfessor.
LeiterderAbteilung"Pharmakologie
undToxikologie ",desBundesgesundheits -
•amtes
k • ' .N •
'StauffenbergstraBe 13 i
"D-1000Berlin30 ■'-
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FRANCE . ';":: .• ^
a)M.PierreGRECH AdjointauDirecteur^
,• ;Ministère delaSantéetdela
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,./ Direction delaPharmacieetdu
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'''pla'cedeFontenoy
"'',,F-7S700Paris
4 Tél.'!567.55.44,poste5492
. -Lignedirecte:306.59.48 ,
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• 4 ' 1
3)Prof.J-.M.ALEXANDRE ■■...Laboratoire dePharmacologie
'_HbpitalBroussais '
96/rueDidot '
, zF-75014Paris
Tél.:539.22.66,poste2349
a)Prof.0.VARGN0S "\"UniversityofAthens -
Department :ofPharmacology "
•-Goudi609
Athens Tél.:'(00301)77.90,841 '
Télex:215927Y.K.Y.P. GR.
b)Mrs.G.MELISSARATOU .",. ,Director,\' -\
'MinistryofSocialServices
Artistotelous 17
Athens Tél.:(00301)52.37,483 -
IRELAND .-\-. /■
a)Dr.AlerieSCOTT MedicalDirector
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57CHarcourtStreet •
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; v 'Tel.:68.10.98,Telex4594(Depf.ofHealth)
b)Prof.OliverFitzGerald -. -.ChairmanoftheNationalDrugs
AdvisoryBoard
57C"HgrcourtStreet,Dublin2
.TéU:68,10.98 ,
S a.■«/B••a)M.PierreGRECH
b)Prof.J-.M.ALEXANDRE ■■.
GREECE

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a)Prof.D.POGGIOLINI
b)Oott.RomanoCAPASaG
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a)Mme.Josannette LOUTSCH-WEYDERT
b)Mlle.Marie-Thérèse STROMMENGERDirettoreGeneraledelServizio
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MinisterodellaSanità
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Tél.S(6)592.5863/(6)592.5824
télex:610453MINSANI.
DirigenteSuperioreChimico
MinisterodellaSanità
DirezioneGeneraleServizio .Farmaceutico
'VialedellaCiviltàRomana,7V
00144R0MA,EUR
Tél.:C6)592.5828
Pharmacien-Inspecteur
Inspection desPharmacies
Ministère delaSanté'publique .
BoulevardJoseph!!,23 •
Luxembourg '■''v
Tél.-:47.55.0T •'
Télex:2546SANTELUX
.Pharmacienattachéàl'Inspection des
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Ministère delaSantépublique ;
BoulevardJoseph .11/28
Luxembourg ,:: •
Tél.:;47.55.01 ;-,'''•
NEDERLAND
a)Dr.C„A.TEIJ6ELER
b)Dr.M.N.G.DUKESVoorzitter
CollegeterBeoordeling vanGenees­
middelen
Ministerie vanVolksgezondheid
Dr.Reijersstraat 10^
Postbus439.
2260AKLeidschendam
Tél.:(070)20.92.60 /,
Télex:32362resp.32347
Plaatsverv .Voorzitter,
CollegeterBeoordeling vanGenees­
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•Koopmansstraat 1''
Postbus5811.
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Tél.:<070)94.95.05
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UNITEDKINGDOM
a)Dr.J.P.GRIFFIN .4-
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Department ofHealthand-
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MedicinesDivision .
MarketTowers
1NineElmsLane
LondonSW85NQ
Tél.:-720.21.88 >ext.3134
Télex:883669
b)Dr.G.JONES PrincipalMedicalOfficer
Department ofHealthand
SocialSecurity
MedicinesDivision
MarketTowers •'
1NineElmsLane.
LondonSW85NQ
Tél.:720.21.88 .
CCE/CEC
a)M.Nicolaas BEL
b)M.PierreDUPRATChefdelaDivision
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Commission desCommunautés européennes
D.G.III/A-3
Administrateur principal
Commission desCommunautés européennes
D.G.III/A-3 - . .
Adressepiostale: Commission desCommunautés européennes
DirectiongénéraleduMarchéintérieur
etdesAffairesindustrielles •
DivisionPharmacie,Médicaments vété­
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D.G.III/A-3'.
RuedelaLoi,200'
B-1049Bruxelles
Téléphone :
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ou735.80.40 !,
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ANNEXEIII FORMULAIRE COMMUN DENOTIFICATION DESDECISIONS NATIONALES
COMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
NOTIFICATION UNDERARTICLE 33
Stateoforigin
Product reference numbers
1.NameoftheProauct :
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EXCHANGE OFINFORMATION )Directive75/319/^"
COMITEPESSPECIALITES PHARMACEUTIQUES
COMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
Président/Chairman:
Mr,LéonROBERT
18/rueJ.P.Koenig
L-1865Luxembourg
Téléphone:<352)260.76-

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ANNEXEV■^y,-
COMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
PROGRESS REPORTONEFFICACY GUIDELINES
1„SubjectofInstruction tothe"workinggroup''
2„Ref»n°Qfdraftactivelyprep-byworkinggroup
.. j3'„DraftsubmittedtoCPMP
-•4.Draftforwardedto
nationalagenciesforcomments |
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theworkinggroup
•«. -•(6.Revised'versionbeforeCPMP/ •– '/1-17.ApprovalbyCPMP
AdootioR and
Fixedcombinations
Non-steroid ,
anti-inflamm.
Antiepileptic
CardiacGlycosides
Bioavailability
Pharmacokin.in man
Antianginal ,
Or.contr.clinical
Ν'Or.contr.informat.
Antihypertensive .
Antihyperglycaemic
Antiarrhythmic 1
Long-term use
Topicalcorticolds
Peripheralcirculat.
Antimicrobial drugs
Pregnancy
Diuretics
X-raycontrast •111/115/79
(ex1387)
111/115/79
(ex1383)
111/634/78
111/635/78
111/573/79
111/1665/79
III/1261/78
III/571/79.
IÎI/572/79
ΠΙ/1667/7901-73
01.-78
04-78
11-78
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11-78
02-79
02-79
05-80
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111/1666/79
111^654/79
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06-78
11-78
06-79
11-78
06-79
06-79
35-8078
02-80
05-8002-80
02-80
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7»Appr
11-7811-78 •
-/
05-80p'-iblication
05-80
05-8011-80
11-80
11-80
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