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Vol.1982/0238

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(82)787 final
1/-\X\\
<4\\Brussels,3December1982
v–*.*\
1.
■ç;nv?jVIeAJs>^
FOURTHCOMMISSION REPORTTOTHECOUNCIL
ONTHEFUNCTIONING OFTHECOMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
C0MC82)787final

-2-
I. INTRODUCTION
1.Council Directive 75/319/EEC provides ,inArticle 15,that the
Commission shall report tothe Council annually ontheoperation ofthe
procedure ofthe Committee forProprietary Medicinal Products andits
effects onthe development ofintra-Community trade .
(**)This Fourth Report covers inparticular the Committee 'sactivities
from July 1981 toSeptember 1982 .
2.The Committee 'sprocedure ,which permits theholder ofamarketing
authorization tosend anapplication formarketing authorization to
atleast five other Member States byway ofthe Member State which
granted theauthorization ,isstill inreality anexceptional procedure
when compared with thefiling ofseparate applications ineach Member
State .
Nevertheless ,the 28applications received infive years ,above all
since the end of1980,are useful pointers onthe way towards the
free movement ofmedicinal products .
3.Cooperation within the Committee between those responsible atnational
level for marketing authorizations has developed further ,especially
asregards the exchange ofinformation onthe side effects of
medicines (drug monitoring ).The increasing part played bythe Committee
inthe coordination ofnational decisions onmarketing authorizations ,
asprovided for inArticles 12and 14ofDirective 75/319/EEC,isthe
most encouraging aspect ofits current operation .
(*) OJNo L147,9.6.75
(**) Thefile references ofthethree previous reports are C0M(79)59 ,22.2.79 ;
C0M(80 )149,31.1.80 ;and C0MC8D363 ,13.7.81 .

-3-
4.The experience gained within the Committee makes auseful contribution
tothe discussions which have been held bythe Council 'sexperts since
November 1981 ontheproposal ^fortheamendment ofDirectives
65/65/EEC,75/318/EEC and 75/319/EEC.The Commission has involved
itself inthese discussions inorder toensure that the new procedure
forthe recognition ofauthorizations that isbeing proposed tomanu­
facturers remains attractive andisnot weighed down with measures
which are likely tobenomore successful than the present procedure .
The Committee 'sexperience will inpart bebeneficial totheactivities
ofthe future Committee for Veterinary Medicinal Products set upby
Council Directive 81/851/EEC^**^ which,together with Directive
81/852/EEC**,will henceforth govern marketing authorization for
veterinary medicines .
5.The development ofintra-Community trade inmedicinal products between
1975 and 1981 isshown inAnnex I.From 1981 onwards ,Greece is
included .In1981,intra-Community trade continued toaccount for the
greater part (70.5 %)ofthetotal imports byMember States .The
balance oftrade inmedicinal products between the Community and
non-member countries isstill insubstantial surplus .
./.
(*) 0JNo C355,31.12.80
(**) 0JNo L317,6.11.81

_L-
II.FUNCTIONING OF THE PROCEDURE PROVIDED FOR INARTICLES 9TO 11 OF
DIRECTIVE 75/319/EEC
1.General
Itshould beremembered first ofallthat the procedure provided for
inArticles 9to11ofDirective 75/319/EECisnot aCommunity
registration procedure for medicinal products .Itisaspecial
means ofsubmitting application dossiers which isintended tomake
iteasier toobtain marketing authorization infive ormore Member
States ,onthe basis ofanauthorization obtained inone Member State
inaccordance with thecriteria set out inthe directives relating to
proprietary medicinal products .During the period for examination of
applications ,which is120 days asinthe case ofthe normal national
procedure provided for inDirective 65/65/EEC,the Member States can
issue reasoned objections onwhich the Committee hastogive its
non-binding opinion within 60days .Atthe end ofthis Community
consultation phase ,the Member States concerned peach adecision
onthe marketing authorization ,applying the same criteria as
inthe purely national procedures and complying with Articles 30to
(  ) .36ofthe EECTreaty and with the Directives relating toproprietary
medicinal products .
2.Applications filed inaccordance with the Committee 'sprocedure
2.1 FillQ2_of _aggliçations
Since the second half of1980 the number ofapplications has been
growing steadily ifalittle slowly .Some applications concern several
different presentations (dosage form orstrength )ofthe same active
principle ,andtherefore ,strictly speaking ,several proprietary
medicinal products .
./.
(*) 0JNo22,9.2.65
(**) Directives 65/65/EEC and 75/319/EECcited above ;
Directive 75/318/EEC,0JNoL147,9.6.75 (tests ofmedicinal products );
Directive 78/25/EEC,OJNoL11,14.1.78 (colouring agents ).

1978 1979 1980 1981 1982 (9months )TOTAL (Sept .82)
Number of
applications2 2 7 7 10 28
Number of
proprietary
medi cinal
products (or
presentations )5 2 12 11 14 44
These 28applications forwarded tothe Committee cover 179national appli
cations forauthorization ,which isanindication that the geographical
spread ofrecent applications has widened .The index forthe number of
countries perapplication hasrisen from 5.875 inJuly 1981 to6.4
inSeptember 1982,the minimum number ofMember States permitted
under the procedure being five .
Asarule the firms ,inagreement with the Member State which has
notified the Committee ,take itupon themselves tosend the dossier
tothe Member States which the application concerns andtothe
secretariat ofthe Committee .Inview ofthe considerable size of
some ofthedossiers ,the time taken forfiling theapplication depends
onhowitisrouted ;the quickest wayisforthe firm itself tofile
the application .
Thesecretariat isinformed bytelex ortelephone bythecountries
receiving theapplications ,inorder that itmayfixthedate when
the 120-day period forexamination ofthedossiers istostart as
soon asthey have arrived inallthecountries concerned .

-6-
2-2 IÍ2Ê_£2yQÍ.£l§I_£2 n£Êrnec '
The 28applications recorded (September 1982 )show that agradual
diversification istaking place asregards theorigin anddestination
ofapplications .
Out of 28
applications
atSeptember 1982Β D DK F GR IRL IT LUX NL UK
Number of
applications
filed bythe
country4 3 5 5 0 0 0 0 0 11
Number of
applications
made to
the country23 17 18 12 5 16 21 26 25 13
Total =
"parti cipation
index "27 20 23 17 5 16 21 26 25 24
Only five countries have forwarded applications :these are,above all,
the United Kingdom ,followed byFrance ,Denmark ,Belgium and Germany .
More effort should perhaps bemade intheother Member States toinform
themanufacturing companies oftheopportunities offered bythe
Committee 'sprocedure .
The countries towhich applications are made are chiefly those
with relatively small markets ,namely Luxembourg ,theNetherlands ,
Belgium and Denmark .Firms have atendency tofile separate applications ,
forexample intheUnited Kingdom ,France andGermany ,before making
useofthe Committee 'sprocedure toapply intheother Member States .
Moreover ,medicinal products areoften registered intheUnited
Kingdom and inIreland simultaneously .
Thetotal ofthe twofigures tosome extent provides anindex ofthe
"participation "ofeach Member State intheprocedure ,both asan
applicant andasarecipient .This "participation index isclearly
very similar foralltheMember States except Greece ,which hasonly
recently joined .

-7-
2.3The_fi_rms _concerned
The Committee 'sprocedure takes place prior tothegranting ofmarketing
authorizations ,and inthe applicants' interest the names ofthe firms
and medicinal products concerned aretherefore not made public .Itshould
benoted ,however ,that the 28applications are more orless equally
shared between major multinationals and medium-sized undertakings .
Itisalso worth taking alook attheoriginal nationality ofthe
undertakings orthe groups towhich they belong ,onthe basis ofthe
information available and onthe understanding that this concept
might give cause for discussion .Itgoes without saying that the
applicant firms areallestablished within theterritory ofthe
Community .
Origin of
groupUSA DK F Β SWEDEN UK D NL
Number of
applications8 7 5 3 2 1 1 1
Number of
firms7 3 5 1 2 1 1 1
2.4 The produçts
The applications cover awide variety ofproduct types :
-4non-steroid anti-inflammatory agents
-3antibiotics
-3analgesics
-3antihypertensives
-1anti-anginal agent
-1oral contraceptive
-1anaesthetic solution
-1anti-osteoclasti c(Paget's disease )
-1potassium
-1calcium
-1antitussive syrup
./.

-8-
-1antidyspepti c
-1anti-smoking drug
-1anti-glaucoma collyrium
-1glucocorticoid-based nasal spray
-1powder for varicose ulcers
-1occlusive gel for surgical use
-1topical solution forthe treatment ofherpes
-1solution for warts
2.5 Presentation_o fdossiers
Onesignificant advantage ofthe Committee 'sprocedure lies inthe
(*)relaxation ofthe language rules setout inanotice toapplicants ,
which isnot always sufficiently known .
Itshould beremembered onthe one hand that the largest part ofthe
dossier ,i.e. that concerning the analytical ,toxi cologi cal and
pharmacological tests and clinical trials ,isaccepted inEnglish
byall the Member States except France ,and inFrench byall Member
States except Germany ,the United Kingdom and Ireland .
The "pharmaceuticals "dossier ,onthe other hand,which concerns the
composition ,the method ofpreparation and the manufacturer 'sroutine
checks ,isaccepted inEnglish byall the Member States except France ,
Germany andItaly ,and inFrench byallthe Member States except
Denmark ,Germany ,Italy andthe United Kingdom .
Aconventional order ofpresentation ofthedossiers ,recommended by
the Committee forProprietary Medicinal Products ,makes thetask of
the Committee and ofthe manufacturers easier .
./.
(*) OJNo C162,2.7.1980

-9-
3.Opinions ofthe Committee
The case provided for inArticle 10.1 ofDirective 75/319/EEC where ,
inthe absence ofanyobjections ,the Committee isnotrequired to
give its opinion ,has not sofar arisen .
Assessing thebenefits tobeexpected from atherapeutic drug asagainst
itsactual orpotential risks isadifficult and complex task forthe
national authorities ,who are anxious toelicit asmany guarantees as
possible before granting marketing authorization .
3.1Reasoned_objections
The frequency oftheinitial objections raised within the 120 days
against the applications indicates that the Member States have so
far taken avery cautious approach .The national authorities tend
always towant more information than isavailable inthe dossier which
served asthe basis for the authorization given bytheoriginal
Member State inaccordance with the Directives .
The information isoften already inthe possession ofthe applicant
but hehas not seen fittopass itoninfull .
There have therefore been numerous questions regarding the analytical
part ofthe dossier .These relate to:
-theimpurities resulting from the method ofsynthesizing theactive
principle ;
-theexact specifications ofstarting materials notreferred toin
the European orrelevant national Pharmacopoeia ;
-precise nature ofthe container ;
-checks carried out during manufacture ;
-specificity ofthe method ofquantitative determination ofthe
active principle inthe finished product ;
-details ofthe stability tests .
Directives 75/318/EEC and 75/319/EECrequire the submission ofsummaries
and anexpert opinion ontheanalytical ,pharmacological /toxicological
andclinical parts ofthedossier ,andthese arenot always provided .
Clear presentation andclear conclusions would undoubtedly help to
reduce the number ofthese objections . /

-10-
Other objections are ofamore serious nature ,calling fortests
additional tothose applied forthe purpose oftheoriginal authorizat­
ion.Some ofthese tests ,such asthe carcinogenicity test,might
take several years tocomplete .Asituation like this canarise when
the ^original authorization wasgranted several years previously but
theopinion oftheexperts hassince moved towards tighter requirements .
Firms aretherefore recommended toupdate their dossiers soasto
adapt them tothe scientific requirements prevailing when they make
their new application .
Inafew cases difficulties have arisen owing tothe small therapeutic
interest ofproducts which donot lend themselves tocontrolled
clinical testing .Itwould seem preferable torefrain from putting
through this procedure products which have only marginal indications
and the need for which might bedisputed .
3.2 The adoption ofopinions
Inspite oftheorganizational problems encountered ,particularly as
regards the rapid translation anddissemination ofobjections ,the
Committee has always managed todeliver its opinions within the
sixty days allowed .
The 21opinions rendered bythe Committee uptoSeptember 1982 break
down asfollows :
-10favourable opinions ,8ofwhich were unanimous ;
-6unfavourable opinions ;
-5divided opinions ^without majority .
Inview ofthefrequency oftheobjections received ,thepredominance
offavourable opinions illustrates thevery active part played bythe
Committee ,which ,after discussion ,succeeds inremoving many ofthe
objections .
./.

-11-
Even inits favourable opinions the Committee indicates tothe
manufacturer those points inthe dossier which still have tobe
clarified inorder tosatisfy the requirements ofthedirectives
onmarketing authorization .Invariably ,the need isfor more precise
details inthe analytical part ofthe dossier orfor amendments to
the general information orthe package insert .
Ifafavourable opinion isnot unanimous ,the conflicting views are
stated aswell .
Unfavourable opinions adopted bythe Committee asawhole tend to
call into question not somuch the products themselves assubstantial
gaps indossiers which have been submitted without having been
brought uptodate .
The divided opinions and,moreover ,the conflicting views expressed
insome ofthe Committee 'sfavourable opinions ,bear witness to
themultiplicity ofchoice inpublic health matters .Any medicinal
product hasits inherent risks and there isnosure criterion for
fixing the level ofrisk acceptable toeach Member State with due
regard tothe therapeutic advantage hoped for.The Commission ,for
itspart,makes sure that the opinions expressed keep within the
bounds ofthe Treaty and the Community directives .
3.3Action_to_be_t aken_on_t he_Commi ttee_|_s_0£2Ql2Q §
When favourable opinions contain reservations ,marketing authorizations
cannot asarule begranted within the time limit of30days from
notification ofthe Committee 'sopinion .
The time taken bymanufacturers toreply tothequestions ofthe
national authorities onthe grounds ofthe opinion ofthe Committee
isitself very variable andissometimes beyond the Committee 's
control ifthe manufacturer does not seefit tosend itacopy of
his reply tothe national authorities concerned .
./.

-12-
Asaremedy forthese drawbacks ,onreceipt ofthe Committee 'sopinion
the Member States notify itofthe action they intend totake .The
Committee then keeps aregular check ontheprogress ofapplications
which are pending ,until the final decision istaken astoauthoriz­
ation orrefusal .
Onthebasis of18initial opinions ofthe Committee -corresponding
to105applications for marketing authorization and 77inprinciple
favourable positions ofindividual members -40marketing authorizations
have already been granted .
Inthe purely national marketing authorization procedure the usual time
limits for examination are suspended whenever ,asisvery often the
case,the authorities want additions tothe dossier (Article 4(c )of
Directive 75/319/EEC).Inlike manner ,applications which have been
the subject ofanopinion from the Committee receive the same treat­
ment aspurely national ones ,but are assured ofdirect Community
supervision oftheir progress .
./.
«

-13-
III .COOPERATION WITHIN THE COMMITTEE
1.General
The Committee for Proprietary Medicinal Products meets about once
every two months ,depending onthe deadlines resulting from the
filing ofapplications for marketing authorization transmitted by
way ofthe Committee 'sprocedure .
Since July 1981,meetings have taken place on7and 8July,6and 7
October and 8and 9December 1981 and on6and 7April ,8and 9June
and 7and 8September 1982 .
Theorganization and work ofthe Committee 'ssecretariat are agrow­
ing burden onthe Commission .Togive anexample ,in1981 the Commit­
tee forProprietary Medicinal Products alone required thetranslation
ofsome 450 pages ofscientific texts .
2.Composition ofthe Committee
The term ofoffice ofthe Chairman andthe members isthree years .
The Chairman may bere-elected once only .
Inthefirst 6years ofthe Committee 'sexistence Mr. Leon Robert
took the Chair for two terms ,having previously taken part asthe
Luxembourg representative invirtually alltheinitiatives and
official meetings inthefield ofpharmaceuticals that hadtaken
place inEurope since 1947,including inparticular the European
Pharmacopoeia ,the Commission ofwhich hehad chaired .Hewas
supported inhistask byhis two Deputy Chairmen ,Professor Duilio
Poggiolini ,Director-General oftheItalian Pharmaceutical Service ,
and Mr. Nicolaas Bel,Head ofthe Pharmaceuticals andVeterinary
Medicinal Products Division ofthe Commission ofthe European
Communities .
Atthe meeting ofSeptember 1982 Dr.Teijgeler ,President ofthe
College ter Beoordeling van Geneesmiddelen intheNetherlands ,
waselected Chairman ofthe Committee forProprietary Medicinal
Products ../.

-14-
Thepresent composition ofthe Committee isgiven inAnnex II.
3.Exchange ofinformation within the Committee
Since 1980 asystem ofinformation exchange hasbeen set upinorder
toenable the Member States thebetter tomeet their obligations
under Articles 30and 33ofDirective 75/319/EEC.
Anetwork ofnational correspondents has been formed andisconstant­
lyupdated sothat itcanreceive bytelephone ortelex information
orquestions onmedicinal products ,especially incases ofemergency
(Annex III).Although the network isnot often used itwas considered
very important tokeep itinoperation ,and asimilar system wasset
uponaninformal basis between 45countries ,including the Member
States ofthe Community ,atthe second meeting ofICDRA (the Inter­
national Conference ofDrug Regulatory Authorities ),organized by
theItalian Minister ofHealth inApril 1982 under the patronage of
the World Health Organization .
Since 1980,systematic notifications tothe Committee ofauthorizat­
ions,withdrawals ,refusals and suspensions ofmedicinal products
have numbered about 5500,acommon form being used forthis purpose .
The Commission has redistributed some 2600 ofthese notifications
tothe Member States for information and tothe Council ofEurope
tohelp inupdating Resolution AP(77)1 onmedicinal products available
only onprescription .
After the new system ofnotifications has been inoperation for two
years the Committee plans toestablish more selective criteria forthe
dissemination ofinformation among the Member States .

-15-
4.Drug monitoring
Ateach ofitsmeetings the Committee discusses questions relating
tothequality ,safety orefficacy ofparticular medicinal products ,
asrequired byArticles 12and 14ofDirective 75/319/EEC.
Thediscussion mainly concerns theside effects ofcertain
medicaments :information available ,investigations inprogress ,
conclusions ofscientific symposia orprocedures for hearing the
firms concerned .This allows the national authorities toknow in
advance the steps which the other Member States intend totake .
The Members ofthe Committee have made itahabit toconsult each
other before taking important decisions onrefusals ,withdrawals
orsuspensions .
Since July 1981,particular attention has been paid tomedicinal
products containing the following active principles :noramidopyrine ,
sodium methanesulphonate ,phenazone ,propyphenazone ,emepronium
bromide ,oxyphenisatine ,aristolochic acid,insoluble salts of
bismuth ,phenacetin ,progestagens ,benoxaprofene ,fenbufene ,tienilic
acid,penfluridol ,dexamethasone ,hydrocortisone ,association of
chloramphenicol with tetracyclin ,etretinate ,bisoxatine ,ticlopidine ,
suxibuzone ,association ofbenzy Ipeni ciIlin with kanamycin ,tiaramide ,
feprazone ,gold salts ,ACTH,nitrofurans ,anorexiants ,preparations
based onBac.subt., benzyl alcohol forpreserving injection
solutions ,amphoprinol ,amrinone ,benfluorex .
5.Committee's panels ofexperts
Under Article 13ofits rules ofprocedure ,the Committee has sofar
set upthree working parties asand when the need hasarisen .
./.

-16-
TheWorkingPartyonMedicinalProductsofPlantOrigin,chairedby
ProfessorSchnieders,hasnotmetagain,chieflybecauseofthe
differences ofopinionamongmembersoftheCommittee astothetasks
tobeassignedtoit.ProfessorSchnieders has,however,sentthe
membersoftheWorkingPartyagooddealofdocumentation resulting
fromstudiescarriedoutbyanadhoccommitteeoftheBundes-
gesundheitsamt .
TheWorkingPartyontheSafetyofDrugs,chairedbyDr.Griffin,has
heldnofurthermeetings,becausethenotesforguidancewhichit
producedtothestudiesonsingle-dosetoxicity,repeated-dose toxicity,
reproduction ,carcinogenesis ,pharmacokinetics andmetabolism in
animalsfromthesafetystandpoint areannexedtoaproposalfora
Recommendation^thatisstillbeingdiscussedintheCouncil.
Theworkingpaperonmutagenicity (111/630/78rev.2)willbebrought
uptodatebytheWorkingPartyastheCouncil'sdiscussions progress.
TheWorkingPartyontheEfficacyofDrugs,chairedbyDr.Dukes,met
on12and13October1981andon24and25February1982andmade
appreciable progresstowardscompletingtwelvenotesforguidance
whichareinvariousstagescftheprocessofwrittenconsultation
withthenationalauthorities andthepharmaceutical industry,as
canbeseeninAnnexIV.TheWorkingParty'sprogrammecovereda
totalof15subjects,thefirstofwhich,namelyfixedcombination ,
products,islikewiseannexedtotheproposalforaCouncilRecommen­
dation^,andthelasttwo,namelycorticoidsfortopicaluseand
antidysrhythmics ,havemadeverylittleprogress.Workhasbeensus­
pendedforthetimebeingsincethedepartureofDr.Dukesforthe
EuropeanRegionalOfficeoftheWHO.
Aconsultation meetingwasheldon6September1982withexpertsfrom
thepharmaceutical industry(EuropeanFederationofPharmaceutical
Industries'Associations )todealinparticularwiththenotesfor
guidancepreparedbytheWorkingPartyontheEfficacyofDrugs.<
(*)OJNoC355,31.^2.80,pp6-30

-17-
IV.CONCLUSION
The Committee forProprietary Medicinal Products has helped toinsti­
tutionalize the dialogue between the representatives ofthe Member
States who are responsible for the marketing ofmedicinal products
and between them and the departments ofthe Commission .
Although Community legislation onmedicinal products isforthe most
part already inexistence ,the individual measures taken inthis field
byeach ofthe Member States now have tobebrought into line .
Inthis respect the Committee isaprivileged instrument for the
harmonization ofnational policies with regard tomedicinal products .
Despite the fact that the Committee 'srole islimited tothat ofa
consultative body acting onbehalf ofthe Commission and the Member
States ,the importance ofits work isnow internationally recognized ,
particularly since the two international conferences ofauthorities
responsible for medicinal products (I.C.D.R.A. )that were held under
the aegis ofthe World Health Organization in1980 and 1982 .
AWorking Party onthe Quality ofDrugs may beset upinthe near
future toaid the Committee inits discussions onthe analytical
part ofthedossiers which itiscalled upon toexamine .
The Commission feels that the Committee could play anincreasing part
incoordinating the review ofold medicinal products ,theregistration ,
dossiers onwhich will have tobebrought into conformity with the
Directives by1990 .

-18-
LIST OF ANNEXES
ANNEX I Intra -and extra-Community trade inmedicinal products
for human and veterinary use.Heading No.30.03 ofthe
CCT
ANNEX II Composition ofthe Committee for Proprietary Medicinal
Products
ANNEX III List ofnational correspondents for the exchanges of
information required byDirective 75/319/EEC
ANNEX IV Status ofwork ofthe Working Party onthe Efficacy of
Drugs

-"9-
INTRAANDEXTRACOMMUNITY TRADE
(Medicinesforhumanandveterinaryuse,
Chapter30.03oftheCommonCustomsTariff)
1.IMPORTS,inmillionsECU,C.C.T.Chapter30.03
Importyear EEC D FITNLB-LUKIRLDKGR
1975
%intraEEC782
74X196
67%18
83Χ91
72X142
87%184
79X79
59%32
90X40
59Χ–
1976
XintraEEC1.034
72X258
62X21
77Χ117
71X199
87Χ230
77X107
59X42
87%56
60Χ–
1977
XintraEEC1.189
73X326
63X35
87Χ112
73%217
84Χ240
76X143
65%49
97%67
64%–
1978
XintraEEC1.447
72X410
63%55
85Χ143
71X259
80%277
76X168
62X59
96%77
58%–
1979
XintraEEC1.648
72X482
65%65
78Χ154
72%281
80Χ301
76%210
65X71
98X82
59%
1980
XintraEEC1.849
72X540
63X101
74%182
73X296
82%322
75X231
69%87
98X90
60Χ–
1981
XintraEEC2.247
70,5X599
60X163
77%226
71X299
82Χ340
68%334
68X108
98%101
58Χ78
55Χ
millions ECU,C.C.T.Chapter30.03(UK1981notavailable )
Exportyear EEC D FITNLB-LUKIRLDKGR
1975
%intraEEC1.786
33%518
31%344
26%116
27Χ126
49%171
66Χ427
23Χ16
59Χ79
24Χ–
1976
%intraEEC2.184
33%642
31%407
26%137
34%179
48%220
65Χ475
24Χ22
65Χ100
24Χ–
1977
%intraEEC2.551
33%708
28%472
28%172
30%211
51%266
63Χ573
24Χ29
72Χ120
24Χ–
1978
%intraEEC2.887
36%768
29%546
32%175
32%232
52%317
65Χ681
27Χ34
72Χ130
30Χ–
1979
%intraEEC3.136
37%862
29%649
33%187
33%237
53Χ334
64Χ675
34Χ45
71Χ147
32Χ–
1980
%intraEEC3.801
35%992
30%828
29%221
31%278
52Χ394
59Χ868
29Χ49
69Χ171
32Χ–
1981
Y.intraEEC–1.193
30%919
31Χ291
26%306
53Χ466
58Χ–58
67Χ219
33Χ25
6Χ

ANNEXE II ANLAGE II ALLEGATO II BIJLAGE II ANNEX II
BILAG II riAPAPTHMA II
-20- octobre /October 1982
COMPOSITION DU COMITE PES SPECIALITES PHARMACEUTIQUES
COMPOSITION OF THE COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
Président /Chairman :
Dr.C.A. TEIJGELER ,V oorzitter College ter beoordeling van geneesmiddelen
vice-Presidents /Deputy Chairmen :
-Prof .Duilio POGGIOLINI ,Direttore Generale del Servizio Farmaceutico
Ministero della Sanità
-M.Nicolaas BEL,Chef deDivision àlaCommission des Communautés
européennes (D.G. III/A-3 )
Secrétariat duComité des spécialités pharmaceutiques /
Secrétariat ofthe Committee for Proprietary Médicinal Products :
D.G. III A3
Commission des Communautés européennes
Rue delaLoi 200
B-1049 Bruxelles
Téléphone : ]_322_/ -235.69.35
-235.51.80
-235.18.90
Télex 21.877 COMEU B

-21-
LISTE DES MEMBRES /LIST OF MEMBERS
a)Représentants /Représentatives :
b)Suppléants /Deputies :
Inspecteur Général ,Inspection générale
delaPharmacie
Ministère délaSanté publique
Cité Administrative ,Quartier Vésale
1010 Bruxelles
Tél.: (2)564.10.64
Télex :25.768
Pharmacien-Inspecteur ,Chef deService
Inspection générale delaPharmacie
Ministère delaSanté publique
Cité Administrative ,Quartier Vésale
1010 Bruxelles
Tél.:(2)564.10.40 ,564.10.41
Télex :25.768
a)Mr.Hans Otto ANDERSEN Sekretariatschef ,cand .pharm .
Sundhedsstyrelsen ,Farmaceutiske Laboratorium
Frederikssundsvej 378
DK-2700 Brønshøj
Tél .:(2)94.37.73
Télex :35333 IPHARM DK
b)Mrs.Agnete Kjærvig KRISTENSEN Afdelingsleder cand .pharm .
Sundhedsstyrelsen ,Farmaceutiske Laboratorium
Frederikssundsvej 378
DK-2700 Br0nsh0j
Tél.:(2)94.37.73
Télex :35333 IPHARM DK
DEUTSCHLAND
a)Prof. Dr. Bernhard SCHNIEDERS Direktor und Professor
Facharzt für Pharmakologie
Leiter des Instituts für Arzneimittel
des Bundesgesundheitsamtes
SeestraRe 10
D-1000 Berlin 65
Tél.: (30)450.20
Télex :183310
b)Prof .Dr.Jorg SCHUSTER Direktor undProfessor
Facharzt für Pharmakologie
Zulassungskoordinator imInstitut für Arznei­
mittel des Bundesgesundheitsamtes
Seestraße 10
D-1000 Berlin 65
Tél.: (30)450.20 /Télex :183310 ,BELGIQUE
a)M.Ben HUYGHE
b)Mme. Denise T0RFS-BRUDER
DANMARK
a)Mr. Hans Otto ANDERSEN

22-
FRANCE
a)M.PierreGRECHChefdeserviceauMinistèredelaSanté,
AdjointauDirecteur delaPharmacieet
duMédicament
Ministère delaSanté
Direction delaPharmacieetduMédicament
1,placedeFontenoy
F-75700Paris
Tél.:567.55.44,poste5492
Lignedirecte:306.56.48
Télex:SANTSEC250011F
b)M.leProfesseur
Jean-Michel ALEXANDREProfesseur dePharmacologie cliniqueau
CentreHospitalier Universitaire
BROUSSAI S
96,rueDidot
F-75014Paris
Tél.539.22.66,poste2349
GREECE
a)ProfessorU.MARCELQU-KINTI
(Mrs.)Vice-President KEEF
VoulisStr.4
Athens
Tél.:32.47.711
b>Mrs.G.MELISSARATOU Director
MinistryofSocialServices
Aristotelous 17
Athens
Tél.:(00301)52.37.483
IRELAND
a)Dr.AleneSCOTT MedicalDirector
NationalDrugsAdvisoryBoard
CharlesLucasHouse
63-64Adelaide Road
Dublin2
Tél.:76.49.71-7
Télex:90542
b)MissM.C.KL00S Pharmacist
NationalDrugsAdvisoryBoard
CharlesLucasHouse
63-64Adelaide Road
Dublin2

ITALIA
a)Prof .Duilio POGGIOLINI
b)Dott .Romano CAPASSO
LUXEMBOURG
a)Mme. Josannette LOUTSCH-WEYDERT Pharmacien-Inspecteur
Division de LaPharmacie etdes
Médi caments
Boulevard Joseph II,28
Luxembourg
Tél.: (352 )47.55.01
Télex :2546 SANTE LU
b)Mlle .Marie-Thérèse STROMMENGER Pharmacien attaché àlaDivision
delaPharmacie etdes Médicaments
Boulevard Joseph II,28
Luxembourg
Tél.: (352 )47.55.01
NEDERLAND
a)Dr. L. OFFERHAUS Internist
Hoofd van deAfdeling Farmacotherapie
van het Staatstoezicht opdeV olks­
gezondheid van het
Ministerie van V olksgezondheid en
Milieuhygiëne
Plaatsvervangend V oorzitter van het
College ter beoordeling van geneesmiddelen
Postbus 5811
2280 HVRIJSWIJK
Tél.:(70)94.95.05 ,ext. 228-23-
Direttore Generale del Servizio Farmaceutico ,
Ministero della Sanità
Viale della Civiltà Romana ,7
00144 ROMA ,EUR
Tél.: (6)592.58.63 /592.58.24
Télex :610453 MINSAN I
Consigliere Ministeriale
Ministero della Sanità
Direzione Generale Servizio Farmaceutico
Viale della Civiltà Romana ,7
00144 ROMA ,EUR
Tél.: (6)593.58.28
./.

-24-
UNITED KINGDOM
a)Dr. J.P.GRIFFIN
b)Dr. G. JONES
CCE /CEC
a)M.Nicolaas BEL
b)M.Fernand SAUERSenior Principal Medical Officer
Department ofHealth and Social Security
Medicines Division
Market Towers
1Nine Elms Lane
London SW8 5NQ
Tél.: (1)720.21.88
Télex :883669
Principal Medical Officer
Department ofHealth and Social Security
Market Towers
1Nine Elms Lane
London SW8 5NQ
Tél.:(1)720.21.88
Chef delaDivision
"Pharmacie ,médicaments vétérinaires "
Commission des Communautés européennes
D.G. III/A-3
Tél.: (2)2351891
Télex :21877 COMEU B
Admini strateur
Commission des Communautés européennes
D.G. III/A-3
Tél.: (2)2355180 /2356935

ANNEXE III ANI.AGE III ALLEGATO III
BILAG III flAPAPTHMA III
-25-BIJLAGE III ANNEX III
COMMISSION
DES
COMMUNAUTES EUROPEENNES
Direction générale du
marché intérieur etdes
affaires industriellesoctobre /October 1982
ECHANGE D*INFORMATIONS
EXCHANGE OFINFORMATIONDirective 75/319 /CEE
EEC
COMITE DES SPECIALITES PHARMACEUTIQUES
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS

-26-
ETAT MEMBRE
MEMBER STATE BELGIQUE
PERSONNES RESPONSABLES DEL'INFORMATION ) . CEE
PERSONS RESPONSIBLE FOR INFORMATION )Directive 75/319/
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Mr.V AN HERPE ,G.
Consei lierMinistère dela
Santé publique et
delaFamille
Inspection général
delaPharmacie
Rue Montagne de
l'Oratoire ,10
B-1010 Bruxelles(2)564.10.29
(2)564.10.64
>Télex :25768(1)
(2)
(3)
Mad.ROLAND ,N.
Inspecteur_ Il– (2)564.10.48
564.11.48(4)
Mad.THYS ,I.
Pharmacien– M– (2)564.10.46 (4)
Mr.MEYER ,P.
Pharmacien– 11. (2)564.10.47 (4)
1
¡
I
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait deLot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
A.)pharmacovigi lance /drug monitoring

-27-
ETAT MEMBRE
MEMBER STATEDENMARK
PERSONNES RESPONSABLES DEL'INFORMATION ) . .7c/T10/CEEPERSONS RESPONSIBLE FOR INFORMATION )Dlrectlve 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Mr.H.O. Andersen
SekretariatschefSundheds styreIsen
Frederikssunds -
vej 378,
DK-2700 Brønshøj(02)94.37.73
Telex :35333
ipharm(1)
(2)
(4)
Mrs.Agnete Kjærvig
Afdelingsleder– 11–(02)94.37.73
Telex :35333
ipharm(1)
(2)
Bodil Strøh
Head ofMedicines
Supply SectionNational Board of
Health
St.Kongensgade 1
DK-1264 København Κ
Danmark
_ 1f_(01)14.10.11 (2)
(3)
Jens Overø
Head ofMedicines
Division
1
I
ι
ί
1
1
1
1
(*) 1.)autorisations demise sur Lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autor isalion defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-28-
ETAT MEMBRE
MEMBER STATE
PERSONNES RESPONSABLES DEL'INFORMATION î . .7I-/-ïio/CEEPERSONS RESPONSIBLE FOR INFORMATION )Directive 75/319/
Teleph .
privât
8117829BUNDESREPUBLIK DEUTSCHLAND
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Dir .u.Prof . Institut für Arz­ (30)450.20
Dr.B.Schnieders neimittel des
Head ofInstitute Bundesgesundheits -Telex :183310 1,2,4
amtes
Seestraße 10
D-1000 BERLIN 65
Dir.u.Prof . . II„ – M–1
Dr.J.Schuster
Coordination of
registration ofdrugs
Dir .u.Prof .
Dr.G.Stille –'ï_ _ Ii_1
Head ,Department
éxperim ./clini cal
pharmacology
Dir.u.Prof ._ II_ _ II_2,4
Dr.P.Schönhöfer
Head ,Department
Drug monitoring
Dr.K.Felden
Mini sterialrat
Dr.Chr .Gaudich
RegierungsdirektorinBundesministerium fü
Jugend ,Familie und
Gesundheit ,
»ostf.200490
>-5300 Bonn 2r(228 )338 251
(228 )338 335
Telex :8-85 5173
3
I
(*) 1.)autorisations demise sur Lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization .
inspection
4.)pharmacovigi lance /drug monitoring

-29-
ETAT MEMBRE
MEMBER STATEFRANCE
PERSONNES RESPONSABLES DEL'INFORMATION
PERSONS RESPONSIBLE FOR INFORMATION jDirective 75/319/CEE
EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation <*)
Type of
information (*)
Pierre GRECH
Chef deService
Adjoint auDirecteurMinistère dela
Santé
Direction dela
Pharmacie etdu
Mèdi cament
1,place de
Fontenoy
F-75700 PARIS567.55 .44
Poste 54.92
Ligne directe :
306.59.481,2,3,4
Yvonne CHA V AUDRET
Pharmacien
chargé dubureau
des Affaires
Internationales567.55.44
Poste 55.04
Ligne directe :
306.59.471,2,3,4
Télex :
SANTSEC
2500 11 F
I
!
Í
I
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-30-
ETAT MEMBRE
MEMBER STATE
PERSONNES RESPONSABLES DEL'INFORMATION î. . /,1Q/CEEPERSONS RESPONSIBLE FOR INFORMATION )Directive 75/319/
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Prof .U.Marcelou-Kinti
Vice-President (Mrs.)
of KEEFKEEF
V oulis St.4
Athens 125(00301 )
32.47.711 1,2,4
Mrs .G.Melissaratou
Pharmacien
DirectorMinistry of
Social Services
Aristotelous 17
Athens(00301 )
52.37.483
Telex :3
Mrs .E.Vardacosta
Head,Directorate of
pharmaceuticals and
pharmaciesMinistry ofSocial
Services
Aristotelous 17
Athens215927 Y .K.Y . P.
GR
(00301 )
52.27.3601,2
Miss A.Varveri
Head ,Section ofStudie
and Proposals
(EEC,FDA,WHO)State Laboratory
sfor the control
ofpharmaceuticals
V oulis St.4
Athens 125(00301 )
32.34.953
or
32.30.6483,4
1
I
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-31-
ETAT MEMBRE
MEMBER STATE IRELAND
PERSONNES RESPONSABLES DEL'INFORMATION )n. .7c/,10/CEEPERSONS RESPONSIBLE FOR INFORMATION )Directive 75/319/
Non etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Dr.A. SCOTT
Medical DirectorNational Drugs
Advisory Board
Charles Lucas House
63-64 Adelaide Road
Dublin 276.49.71 -7
Telex :90542Κ2,3,4
I
!
i
I
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-32-
ETAT MEMBRE
MEMBER STATE
PERSONNES RESPONSABLES DEL'INFORMATION ) . . 7c/-,10/CEEPERSONS RESPONSIBLE FOR INFORMATION )Dlrect1ve 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Prof .Duilio POGGIOLINI
Direttore Generale del
Servizio FarmaceuticoMinistero della
Sanità
Servizio
Farmaceuti co(6)592.58.63
(6)592.58.24
Telex :1,2,3,4
Viale della
Civiltà Romana ,7
00144 ROMA EUR610453 MINSAN I
Dr.Romano CAPASSO
Consigliere Ministerialβ II.
Λ(6)592.58.28 1,2,3,4
1
¡
I
I
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoringITALIA

-33-
ETAT MEMBRE
MEMBER STATE LUXEMBOURG
PERSONNES RESPONSABLES DEL'INFORMATION î„. ..,c/,in/CEE
PERSONS RESPONSIBLE FOR INFORMATION )Direct1ve 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Mad.LOUTSCH-WEYDERT ,J.Division dela
Pharmacie etdes
Mèdi caments
28,bd.Joseph II
Luxembourg47.55.01
Télex :
2546 SANTE LU1,2,3,4
1
i
i
t
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-34-
ETAT MEMBRE
MEMBER STATENETHERLANDS
PERSONNES RESPONSABLES DEL'INFORMATION î CEE
PERSONS RESPONSIBLE FOR INFORMATION )Dlrect1ve 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .&TelexType d'infor­
mation (*)
Type of
information (*)
Drs .R.A. Drost ,
inspecteur
Dr. C.A. Teijgeler ,
V oorzitter
Drs .R.H.B.
inspecteurMeyboom ,Ministerie van
V olksgezondheid ,
College ter beoor­
deling van
geneesmiddelen
Case postale 5811
2280 HVRijswijk (ZH)(70)94.95.05
Télex :32691
Ministerie van
V olksgezondheid ,
College ter
beoordeling van
geneesmiddelen
Case postale 439
2260 AKLeidschendar »
M(70)20.92.60
Télex :32362
vmni2+3
– –
(*) 1.)autorisations demise sur Lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication ,inspections /manufacturing authorization ,
inspection
4.)pharmacovigi lance /drug monitoring

-35-
ETAT MEMBRE
MEMBER STATEUNITED KINGDOM
PERSONNES RESPONSABLES DEL'INFORMATION )„. ,CEE
PERSONS RESPONSIBLE FOR INFORMATION -jDirective 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeLeph .&TeLexType d'infor­
mation (*)
Type of
information (*)
TeLex :
883669
TeLephone :
(1)720.21.88
Mr.W. CROSTON
PrincipaL Licensing
Off ieerDHSS
Market Towers
1Nine ELms Lane
London SW8 5NQext. 3413 1
Mr.R. BAKER
Superintending
Medicines Inspector_ II„ ext. 3353 or
33542+3
Dr.R. PENN
PrincipaL MedicaL
Off ieer– M ext. 3143 or
31464
J
i
I
1
»
1
(*) 1.)autorisations demise sur Lemarché /marketing authorizations
2.)retrait deLot,interdiction dedéLivrance /batch withdrawaL ,
prohibition ofsupply
3.)autorisation defabrication -inspections /manufacturing authorization ,
inspection
4.)pharmacovigi Lance /drug monitoring

-36-
COMMISSION DES C.E.
COMMISSION OFTHE E.C.
PERSONNES RESPONSABLES DEL'INFORMATION ).... CEE
: – 1nirertiiu 7Ç/710 /PERSONS RESPONSIBLE FOR INFORMATION )Dlrect1ve 75/319/EEC
Nom etFonction
Name and FunctionAdresse
AddressTeleph .STelexType d'infor­
mation (*)
Type of
information (*)
Mr.N. BEL
Chef deDivisionCommission des
Communautés
européennes
D.G. III/A-3
Rue delaLoi 200
B-1049 Bruxelles(2)235.18.91 ou
(2)235.18.90
(secrétariat )
ou
(2)235.69.35
(secrétariat )
Télex :1,2,3,4
21877 COMEU Β
Mr.F. SAUER
Administrateur β »1β _ »I.
(2)235.51.80 ou
(2)235.69.35
(secrétariat )1,2,3,4
1
1
(*) 1.)autorisations demise sur lemarché /marketing authorizations
2.)retrait delot,interdiction dedélivrance /batch withdrawal ,
prohibition ofsupply
3.)autorisation defabrication -inspections /manufacturing authorization .
inspection
4.)pharmacovigi lance /drug monitoring

ANNEXE IV ANLAGE IV ALLEGATO IV BIJLAGE IV ANNEX IV
flAPAPTHMA TV
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
PROGRESS REPORT ONEFFICACY GUIDELINES
Stages :1 2 3 4 5^ 6 7 8' 9
Fixed combinations
Cardiac glycosidesIII/115/79
III/635 /7801-78 11-78 0.J.E.C. 31-12-80C355
11-78 12-78 06-80 11-80
Or.contr .clinical III/571/79 03-79 06-79 02-80 05-80 06-80 11-80
Or.contr .inform . III /572 /79 03-79 06-79 02-80 05-80 06-80 11-80
Antihypertensive III/1667 /7905-80 05-80 (0MS /WH0 text )
Long-term use III/602 /81 12-81 01-82
N.St .Anti-Inf lam .III /601/81 01-78•···· ι10-81 12-81 01-82
Antiepi leptic III/634 /78 04-78 06-78 10-81 12-81 01-82
Bioavai labi lity III/573/79 03-79 06-79 10-81 12-81 01-82
Pharmacokin.in man II1/603/81 12-81 01-82
Anti anginal III/1261/7811-78 12-78 02-82
Ischaemia inthe .
limbsAntimicrobialIII/1270/81
III/1666 /7912-81
05-8001-82
05-80 02-82
Topical corti co'idsIII/225 /82
Antidysrhytmic
1.=Subject ofinstruction totheworking party
2.=Reference No.ofdraft actively prepared .byworking party
3.=Draft submitted toCPMP
4.=Draft forwarded tonational agencies andindustry forfirst comments
5.=Rediscussion ofcomments intheworking party
6.=Revised version before CPMP
7.=Draft circulated tonational agencies andindustry
8.=Approval byCPMP
9.=Adoption andpublication¿XBILAG IV "r-
March 1982