ARCHIVES HISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(80)149
Vol.1980/0047

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(80 )149 final
/v'- Brussels ,31st March 1980
Γ \
%*,.<iA
SECOND COMMISSION REPORT TOTHE COUNCIL
ONTHE FUNCTIONING OFTHE COMMITTEE FOR PROPRIETARY
MEDICINAL PRODUCTS AND ITS IMPACT
ONTHE DEVELOPMENT OFINTRA-COMMUNITY TRADE
(1979 )
COM (80)149 final

SecondCommissionreportonthefunctioning oftheCommitteeforProprietary
MedicinalProductsanditsimpactonthedevelopment ofintra-Community trade
(1979)
CouncilDirective 75/319/EECrelatingtoproprietary medicinalproducts
(OJL147of9June1979)provides,inArticle15(1),that"theCommission
shallreporttotheCouncilannuallyontheoperationoftheprocedurelaid
downinthisChapter(CommitteeforProprietary Medicinal Products)andits
effectsonthedevelopment ofintra-Community trade".
Thisreportcoverstheyear1979.
A .. " "
I.THEFUNCTIONING OFTHECOMMITTEE FORPROPRIETARY MEDICINAL PRODUCTS
1.Membership . -
(a)Committee
Thetermsofofficeofthememberswere,renewedasfrom1December1979.
< ~ •
ThemembershipoftheCommittee wasnotchangedasregardsthefull
members.
Dr.JONES,PrincipalMedicalOfficer,MedicinesDivision,wasappointed
analternate memberfortheUnitedKingdom.
ItwasresolvedthattheChairmanandVice-Chairmen oftheCommittee
wouldremainintheiroffice(cf.AnnexI).
(b)Groupsofexperts
Themembershipofthegroupsofexpertshasvariedaccordingtotheitems
ontheagenda.Alistoftheparticipants inthesegroupsisgivenin
AnnexII.

ν
-2-
2.functioning
TheCommittee metsixtimes,onthefollowing dates:20February 1979,
13and14March,19and20April,7and8June,11and12September,
14November .
The"SafetyofDrugs"panelmetthreetimes,i.e.,on16and17January
1979,3and4Apriland3and4December.
The"Efficacy ofDrugs"panelalsometthreetimes,i.e.,on13and14
February 1979,3and4Apriland3and4December.
%
TheMedicinal Products ofPlantOrigin"panelmeton12March1979.
3-2B2L'i2;3S_2l_il3f_£2!2!D2£££S '
3.1Opiniohs onthebasisofArticle 11ofDirective 75/319/EEC
Until31December 1979twoopinions were.delivered bythe.-Committee .
Furthermore ,twonewapplications formarketing authorization wereforwar­
ded,pursuanttoArticle 9ofDirective 75/319/EEC.Theprocedure inthe
caseofthesetwonewapplications hadnotbeencompleted bytheendof
theperiodcovered bythisreport.
Inspiteofthisverylimitedexperience ,thefollowing factsemerged:
-notallmanufacturers presented theparticulars inconformity with
theplanadopted bytheCommittee forProprietary Medicinal Products
andreproduced inthebookletpublished bytheCommission ofthe
European Communities in1978underthetitle"Therulesgoverning
medicaments intheEuropean Community",page57etseq.Thiscaused
lossoftimeatthelevelofbothnational andCommunity examination ;
-itisdifficult,intheabsenceofguidelines prepared bythepanels
ofexpertsoftheCommitter,toachievecomplete harmonization of
thetherapeutic indications ,contra-indications ,warnings andside-
effects,sincedifferent nationalattitudes havebeenadopted
./.

-3-
forvariousproducts ofisimilarnatureandthatItwouldtherefore
bedifficult tojustifyatnational leveLanabruptchangeofdoctrine
foraparticular case;
-supervision ofthestability periodbroughttolightdivergentatti­
tudes:certainauthorities acceptaccelerated studies,othersonly
acceptreal-timetrials; ;
-certainauthorities contacted theapplicant duringthe120daysof
examination andthushaveadditional information-which theother
authorities donotpossess;
-thetime-limits laiddowninArticles 10and11oftheabovementioned
Directive areveryshort,evenifithasbeenpossibletocomplywith
theminthiscase;
-thetimeforsendingfilesbyposttoalltheMemberStatesspecified
hasneverbeenlessthanonemonth.
3.2OpiniononthebasisofArticle 12ofDirective 75/319/EEC
Onthebasisoftheabovementioned Article 12,theCommittee wasasked
-foranopinionconcerning clofibrate .
Allthedelegations ,exceptone,statedthatclofibrate wouldremainon
theirrespective marketssubjecttolimitation oftheindications ,the
formulation ofrevisedwarnings andcontra-indi cationsandspecial
information forthemedicalprofession . '
Subsequently ,allthenationalauthorities adoptedanattitudeidentical'
tothatreported above.
3.3OpiniononthebasisofArticle 14ofDirective 75/319/EEC
1
TheCommittee wasconsulted onanddulyexamined thefollowing medicines
forproblems ofinteresttotheCommunity :Alclofenac ,Aminophenazone -
andderivatives ,Benperidol ,Biguanides (Buformine,Metformine,
Phenformine ),Chloramphenicol ,Clioquinol,Dinoprostone ,Furazolidone ,
Hydrazinophtalazine ,Inosine,Methapyri lene,Noramidopyrine ,Triazolam .
./

-4-
4.Aetivrt£_ofthe_exgert_gane],s
Thethreepanelsofexpertssetupinaccordance withArticle 13ofthe
Committee'srulesofprocedure continued theirwork.
4.1Thepanelon"SafetyofDrugs",chairedbyDrJ.P.GRIFFIN,hascompleted
thedrafting,afterconsultation withnationalauthorities andprivate
associations andexamination oftheircomments,ofthefollowing
guidelines :
-singledosetoxicity studies;
-repeated dosetoxicity studies;
-reproduction studies;
-carcinogenicity studies;
-inhalation toxicity studies;
-pharmacokinetics .
Aguideline onthemutagenicity testshasstilltoberevisedinthe
lightofthecomments received .
4.2Thepanelon"Efficacy ofDrugs",chairedbyDrM.N.6.DUKES,has
completed thedrafting,afterconsultation withnationalauthorities
andprivateassociations andexamination oftheircomments,ofa
guideline onfixedcombinations ofmedicines .Afterafinalrevision,
thesameprocedure willbeappliedtothenoteonanti-inflammatory
preparations .
Thefollowing guidelines arebeingprepared orareattheplanning stage:
-antiepileptics/anticonvulsants ;
-bioavialabi lity; •'
-cardiacglycosides ;
-humanpharmacokinetics ;
-antianginal agents;
-oralcontraceptives .(tests);
-oralcontraceptives (information forusers);
-antihypertensive agents;
-hypoglycemic agents;
./.

-5-
-antiarrhythmic agents;
-medicines usedoveraLongperiod; '
-Localcorticoids ;
-peripheral vasodilators ;
-antimicrobial agents;
-medicines andpregnancy ;
-diuretics ;
-contrast media.
4.3Thepanelon"Medicinal ProductsofPlantOrigin",chairedby
Professor B.SCHNIEDERS ,considered itadvisable,beforeproceeding
further,tocollectbibliographical dataohthequality,efficacy
andharmlessness ofplantsandpreparations basedonplants.
4
4.4Aftertheadoption oftheseguidelines bytheCommittee forProprietary
Medicinal Products,itwillrestwiththeCommission togivethemthe
appropriate legalform.
5-Other_act2yi^tji es_of_the _Committee
5.1TheCommittee hasamendedorclarified thenoticetothemanufacturers
andimporters ofproprietary medicinal products published inOJN°
C302of15December 1977,withregardtothefollowing threepoints:
-thelanguages inwhichcertainpartsofthefilecanbesupplied;
-thecountries whichrequestthatthefilebeaccompanied bysamples-
oftheproprietary product;
-thefactthatthenationalregistration feesremainapplicable aslaid
downbythenational laws.
5.2TheCommittee expressed itsopiniononthedesirability ofdrawing up
aCommunity modelofadatasheetwhichwouldbeusedtosummarize the
marketing authorization andwhichcouldalsobeusedforotherpurposes,
e.g.,medicalinformation .Ithasprepared alistoftheessential
information tobestatedonthissheet.
./.

5.3TheCommittee alsoassessedthesituation withregardtodrugmonitoring
andconsidered thatthereshouldbemoresystematic mutualinformation
onanypotential danger.Anearly-warning systemhasbeenintroduced for
thispurpose.
5.4ThesystemlaiddowninArticle 33ofDirective 75/319/EECfornotifying
«
decisions adopted bythecompetent authorities hasbeenimproved .
Aspecialtreatment hasbeeninstituted formarketing authorizations
concerning newsubstances /saltsoresters,newroutesofadministration ,
newcombinations ,important newindications andnewdosages andfor
refusals andrevocations ofMAs,theprohibition ofsupplyandwith­
drawalfromthemarket.

-7-
II.DEVELOPMENT OFINTRA-COMMUNITY TRADE
Thedata aretaken from theAnalytical Tables ofForeign Trade -NIMEXE
1978 -published bytheStatistical Office oftheEuropean Communities ,
Thestatistics aregiven inEuropean units ofaccount (EUA).
Table 6can beused for conversion tonational currencies .

1.a)Importsofmedicaments forclinicalandveterinary medicine(Value:1000EUA)(Chapter30.03ofthe
CommonCustomsTariff)
Origin EUR9 DE FR IT NE B-L UK IR DA
1978
Intra-Com.1.033.581 259.912 46.684 102.069 207.398211.527 104.854 56.828 44.309
Extra-com.413.7S3150.263 8.186 40.991 51.57865.500 63.026 2.09132.353
•1 •
1.b)Percentageofintra-Community importsintotalimportsofmedicaments ~
'
72%63%85%71%80%76X62%96X58%ι
00
I

2.a)Importsofmedicaments packagedforretailsale(value:1000EUA)
Origin EUR9 DE FR IT NE B-L UK IR DA
1978 - . '
Intra-Com.737.600 156.543 30.444 63.570 168.815 146.571 82.148 51.384 38.126
Extra-Com.195.957 79.673 4.733 23.085 23.018 19.425 25.451 1.747 29.918
2.b)Percentageofintra-Community importsintotalimportsofmedicaments packagedforretailsale ''>»
-1974 81% 73%82%77%92%89% 73%91%58%
-1978 79% 66%87%73%88%88% 76%97X56%-•c
>
N

10-
2.c)Percentage ofmedicaments packaged forretailsaleIntotalCommunity
medicaments imports
In1978medicaments packaged forretailsaleaccounted for64.5%of
medicaments imported bytheCommunity .Thisfigureisslightly lower
compared withthoseforprevious years,whichweremarkedbyaconstant «
increase intherelevantfiguresince1974<66Xin1977,65%in1976,
64%in1975,63%in1974). »
Ifonlyintra-Community importsareconsidered ,packaged medicaments
accountfor71.3%ofthetotalintra-Community importsofmedicaments
<69.3%in1974and1975,71%in1976,72.4%in1977).

3.a)Exportsofmedicamentsforclinicalandveterinary medicine(Value:1000EUA)(Chapter30.03ofthe
CommonCustomsTariff)
Destination EUR9 DE FR IT NE 8-L UK IR DA
1978
Intra-Com.1.032.774223.292 172.214 56.511120.084 207.413 187.139 24.632 38.489
Extra-com.1.853.801 545.064 371.354 118.514 111.628 109.537 494.305 9.513 91.856
3.b)percentageofintra-Community exportsintotalexportsofmedicaments
36%29%32% 32%52%65%27%72%30%

4.a)Exports ofmedicaments packaged forretail sale (Value :1000EUA)
Destination EUR9 DE FR IT NE B-L UK », IR DA
1978
Intra-Com .796.544 191.593 119.016 35.583 81.730 193.308 122.424 15.235 36.655
Extra-Com .1.555.042 444.373 339.726 104.475 93.487 99.789 381.268 7.073 84.852
\
b)Percentage ofintra-Community exports intotal exports ofmedicaments packaged forretail sale
-1974 32X 33% 24X ;26X 39% 65X 24% 57% 17X
-1978 34% 30% 26% 25% 47X 66X 24X 68X 30X
'f^rcentage ofmedicaments packaged forretail sale intotal Community exports ofmedicaments
In1978/medicaments packaged forretail saleaccounted for81.4 Xofthemedicaments exported by
theCommunity .

5.Development oftradeinmedicaments packagedforretailsale(index100in1974)
DE FR IT NE B-LUK IR DA
Indices -,-n1978
Importe
,intra-Com.264 331 141 209 162 242 191 216
extra-Com.368 235 173 361 172 202 67 238
Exports
intra-Com.163 301 324 368 224 293 639 <405
extra-Com.197 203 238 219 218 238 334 195
©•ValueoftheEuropeanunitofaccount (EUA)
1EUA= DM FF Lit Hfl BF.UKL IRL DKr
1978'2,55607 5,73983 1080,216 2,75409 40,06110,663910 0,663888 7,01946

Comments
Itis,ofcourse,unnecessary toassesstheeffectsoftheCommittee's
procedure onthedevelopment ofintra-Community trade,inviewofthe
factthatithasbeenusedsoLittle.

ANNEX1
COMITE DES SPECIALITES PHARMACEUTIQUES
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
Président /Chairman :
M.Léon ROBERT
Vice-Présidents /Deputy Chairmen :
1.Prof .Duilio POGGIOLINI
2.M.NicOlaas BEL
a)Représentants /Représentatives :
b)Suppléants /Deputies :
BELGIQUE
a)M.Ben HUYGHE
b)Mme. Denise TORFS-BRUDER
DANMARK
a)Mr. SteenANTQN SEN
b)Mr.Hans Otto ANDERSEN18,rueJ.P. Koenig
Luxembourg
Tél.:260.76
Direttore Generale del Servizio Farma­
ceutico
Ministero della Sanità
Via Civiltà Romane
ROMA EUR 'j
Tél.:59.58.63 /59.58.24
Télex 610453 MINSAN
Chef deDivision àlaDirection générale
duMarché intérieur etdes
Affaires industrielles
Commission des Communautés européennes
1049 Bruxelles ,ruedelaLoi200
Tél.:735.00.40 /1891
Inspecteur Général ,Inspection générale
delaPharmacie
Ministère delaSanté publique
Cité Administrative ,Quartier Vésale
1010 Bruxel les
Tél.:564.10.64
Télex :25.798 \
Pharmacien-Inspecteur ,
Inspection générale delaPharmacie
Ministère delaSanté publique
Cité Administrative ,Quartier Vésale
1010 Bruxelles
Tél.:564.10.64
Télex :25.798
Laboratoriechef
Sundhedsstyrelsen ,Farmaceutiske Labora­
torium
Frederikssundsvej 378,DK-2700 Brénshcj
Tél.:02-94.37.73
Télex :35333 (ANTONSENXanswer :IPHARM DK>
Sekretariatschef ,
Sundhedsstyrelsen ,Farmaceutiske Labor .
Frederikssundsvej 387,DK-2700 Brénshéj
Tél.:02-94.37.73
/

BUNDESREPUBLIK DEUTSCHLAND
a)Prof.Dr.BernhardSCHNIEDERS
b)Prof.Dr.GOnterAflmannLeiterdesInstitutsfürArzneimittel des
Bundesgesundhei tsamtes
D-1000Berlin30,Stauffenbergstr.13•
Tél.:26.37.203oder204
Télex:183310
LeiterderAbteilung"Pharmazeutische
FragenderArzneimittelzulassung "des
InstitutsfürArzneimittel desBundes-
gesundheit samtes
D-1000Berlin30,Stauffenbergstr.13
TMex183310
FRANC:
a)M.JeanUEBER
b)M.PierreGRECHDirecteur delaPharmacieetduMédicament,
MinistèredelaSantépubliqueetdela
sécuritésociale
1,PlaceFontenoy,75007Paris
Tél.:567.55.44
Lignedirecte:306.59.47
Télex:250011SANTSEC F
Pharmacien-Inspecteur delaSantéauService
CentraldelaPharmacieetdesMédicaments
MinistèredelaSantépubliqueetdela
Sécuritésociale
1,PlaceFontenoy,75007Paris
Tél.:567.55.44
IRELAND
a)Dr.AleneSCOTT
b)Prof.OliverFitzGeraldMedicalDirector
NationalDrugsAdvisoryBoard
57CHarcourtStreet
Dublin2
Tel.:68.10.98
Télex:4894(DepartmentofHealth)
ChairmanoftheNationalDrugsAdvisoryBoard
57CHarcourtStreet,Dublin2
Til.:68.10.98
ITALIA
a)Prof.DuilioP0GGI0LINI
b)Dott.RomanoCAPASS0DirettoreGeneraledelServizioFarmaceutico
MinisterodellaSanità
ViaCiviltàRomane
ROMAEUR
Tél.:59.58.63/59.58.24
Télex:610453MlNSAN
DirigenteSuperioreChimico
MinisterodellaSanità
DirezioneGeneraleServizioFarmaceutico
ViaCiviltàRomane
ROMAEUR
Tél.:59.58.63/59.58.24

LUXEMBOURG
.s •
a)Mme.Josannette LOUTSCH-WEYDERT Pharmacien-Inspecteur ,
Inspection desPharmacies,
Ministère deLaSantépublique
Boulevard JosephII,28
Luxembourg
Tél.:47.55.01
Télex:2546SANTELUX
b>Mlle.Marie-Thérèse STROMMENGER Pharmacien attachéàl'Inspection des
Pharmacies,Ministère delaSantépublique,
BoulevardJosephII,28
Luxembourg
~ Tél.:47.55.01
NEDERLAND - ,,
a)Or.C.A.TEIJGELER ^Voorzitter,CollegeterBeoordeling van
Geneesmiddelen
Ministerie vanVolksgezondheid
-Dr.Reijersstraat 10,Leidschendam .
Tél.:(070)20.92.60
Télex:32362oder32347
b)Or.M.N.G.DUKES Plaatsverv .Voorzitter,Collegeter
Beoordeling vanGeneesmiddelen
Ministerie vanVolksgezondheid
Dr.Reijersstraat 10,Leidschendam
Tél.:(070)20.92.60
UNITEDKINGDOM
SeniorPrincipalMedicaiOfficer
MedicinesDivision
Department ofHealthandSocialSecurity
FinsburySquareHouse
33-37AFinsburySquare,LondonEC2A1PP
Til.:<01)638.60.20,ext.388
b)Dr.G.JONES PrincipalMedicalOfficer
Medicines Division
DepartmentofHealthandSocialSecurity
FinsburySquareHouse
33-37AFinsburySquare,LondonEC2A1PP
T61.:(01)638.60.20,ext.385'
CCE/CEC
a)M.NicolaasBEL ChefdeDivisionàlaDirectiongénérale
duMarchéintérieuretdesAffaires
industrielles
Commission desCommunautés européennes
1049-Bruxelles,ruedelaLoi200
Tél.:735.00.40/1891
&)M.PierreDUPRAT Administrateur principal,
DirectiongénéraleduMarchéintérieuret
desAffairesindustrielles
Commission desCommunautés européennes
1049-Bruxelles,ruedelaLoi200
'Tél.:735.00.40/3524a)Dr.J.P.GRIfFIN
c
a)M.NicolaasBEL
b)M.PierreDUPRAT

ANNEXII
GROUPEDETRAVAIL"SECURITE DESMEDICAMENTS /WORKINGPARTY"SAFETYOFDRUGS"
Dr.J.P.Griffin
SeniorPrincipalMedicaiOfficer
MedicinesDivision
D.H.S.S.
FmsburySquareHouse
33-37AFinsburySquare
LondonEC2A1PP
ProfessorJ.VanNoordwijk
Rijks-Instituut voorde
Volksgezondheid
P.O.Box1*
3720BABilthoven
NetherlandsDr.MorrellDraper
DepartmentofHealthandSocialSecurity
Medicines Division
FinsburySquareHouse
33-37AFinsburySquare
LondonEC2A1PP
UnitedKingdom
ProfessorGiorgioSegre
IstitutodiFarmacologia
Università diSiena
ViaBanchideSotto55
53100Siena
Italy
Professor JensS.Schou
DepartmentofPharmacology
UniversityofCopenhagen
20JulianeMariesVej
DK-2100Copenhagen 0
Denmark
Professor H.D.Brede
Paul-Ehrlich-Iristitut
Paul-Ehrlich-Str.42-44
D-6000Frankfurt/M.
DeutschlandProfessor C.Harvengt
Laboratoire dePharmacothérapie
Université Catholique deLouvain
SitedeLouvainenWoluwé
UCL5349TourPasteur
1200Bruxelles
Belgique
Dr.M.Conalty
MedicalResearchCouncilLaboratories
TrinityCollège ,
Dublin
Ireland
Dr.P.Grosdanoff
InstitutfürArzneimittel des
Buncesgesundheitsamtes
Stauffenbergstr .13
D-1000Berlin30
Deutschland
Dr.W.Christ
InstitutfürArzneimittel des
Bundesgesundheitsamtes
Stauffenbergstr .13
D-1000Berlin30
Deutschland
Professor R.Bass
InstitutfürArzneimittel des
Bundesgesundheitsamtes
Stauffenbergstr.13
D-1000Berlin30
DeutschlandProf.G.Olive
I.N.S.E.R.M.
101,ruedeTolbiac
F-75013Paris
France
Professor G.Stilie
InstitutfürArzneimittel des
Bundesgesundheitsamtes
Stauffenbergstr .13
D-1000Berlin30
Deutschland
Dr.G.Jones
PrincipalMedicalOfficer
MedicinesDivision
D.H.S.S.
FinsburySquareHouse
33-37AFinsburySquare
LondonEC2A1PP
UnitedKingdom

GROUPEDETRAVAIL"EFFICACITE DESMEDICAMENTS"
WORKINGPARTY"EFFICACYOFDRUGS"
LISTED'ADRESSES
LISTOFADDRESSES
Prof.J.M.ALEXANDRE
Laboratoire dePharmacologie
HôpitalBroussais
96rueDidot
F-75014Paris
France
Dir.Prof.Dr.K.-W.vonEICKSTEDT
InstitutfürArzneimittel des
Bundesgesundheitsamtes
Stauffenbergstr.13
D-1000Berlin30
Deutschland
Dr.EnricoGENAZZANI
IstitutodiFarmacologia eTerapia
esperimentale
CorsoRaffello30
I-Torino
ItaliaDr.M.N.G.DUKES
Div.ofPharmacotherapy
CentralDrugInspectorate
MinistryofPublicHealthand
Environmental Hygiene
DokterReijersstraat 10
Leidschendam
Netherlands
Prof.OliverFITZGERALD
Dept.ofMedicineandTherapeutics
Umversity Collège
Woodview
Stillorgan Road
Dublin,4
Ireland
Prof.Dr.EigillF.HVIDBERG,
Dept.Clin.Pharmacology
llniversityHospital(Rigshospitalet )
9Blegdamsvej
DK-2100Copenhagen 0
Denmark .
Dr.G.JONES
DepartmentofHealthandSocialSecurity
MedicinesDivision
FinsburySquareHouse
33-37AFinsburySquare
LondonEC2A1PP -
UnitedKingdomDr.L.OFFERHAUS
Div.ofPharmacotherapy
CentralDrugInspectorate
MinistryofPublicHealthand
Environmental Hygiene .
DokterReijersstraat 10
Leidschendam
Netherlands
Dr.R.G.PENN Prof.Dr.J.REUSE
DepartmentofHealthandSocialSecurityLaboratoire dePharmacodynamic
MedicinesDivision Université LibredeBruxelles
FinsburySquareHouse 115Boulevard deWaterloo
33-37A.FinsburySquare 1000Bruxelles
LondonEC2A1PP Belgium
UnitedKingdom ,
Dr.A.SCOTT
NationalDrugsAdvisoryBoard
57CHarcourtStreet
Dublin.2
IrelandDir.Prof.Dr.J.SCHUSTER
InstitutfürArzneimittel des
Bundesgesundheitsamtes
Stauffenbergstrasse 13
D-1000Berlin30
Deutschland -,

3
GROUPEDETRAVAIL"MEDICAMENTS ABASEDEPLANTES"
WORKINGPARTY"MEDICINAL PRODUCTS OFPLANTORIGIN"
Or.SteenANTONSEN
Sundhedsstyrelsen ,
Farmaceutiske Laboratorium
Frederikssundsvej 378
DK-2700BRØNSHØJ
Danmark
Prof.PierreCTELAVEAU
FacultédesSciencespharmaceutiques
Université deParis
4,jjvenuedel'Observatoire
P.-7^006PARIS
Fj^pce
MissC.GOLDON
NationalDrugsAdvisoryBoard
CharlesLucasHouse
HarcourtStreet
DUBLIN2
I|eland
Çrof.J.LEMLI
Laborotorium Farmacognosie
VanEvenstraat 4
B-3000LEUVEN
BelgiqueDr.J.M.CALDERW00D
Department ofHealthand
SocialSecurity,MedicinesDivision
FinsburySquareHouse
33-37AFinsburySquare
LONDONEC2A1PP
UnitedKingdom
Prof.CorradoGALEFFI
IstitutoSuperiorediSanità
VialeReginaElena299
1-00161 ROMA
Italia
Prof.Dr.T.HUIZINGA
Laboratorium voorFarmacotherapie
enReceptuur
Ant.Deusinglaan 2
GRONINGEN
Nederland
Prof.Dr.Bernhard SCHNIEDERS
LeiterdesInstitutsfür
Arzneimittel des
Bundesgesundheitsamtes
Stauffenbergstrasse 13
D-1000BERLIN30
Deutschland
Commission desCommunautés européennes
Secrétariat duComitédes
spécialités pharmaceutiques
mrN.BEL
RondPointSchuman3
Bureau7/3
1049BRUXELLES
Belgique
Tél.02/735.00.40,ext.1891Commission oftheEuropeanCommunities
Secretariat oftheCommitteefor
Proprietary MedicinalProducts
mrN.BEL
RondPointSchuman3
Office7/3
1049BRUSSELS
Belgium
Tel.02/735.00.40,ext.1891