Contact Points for advice on Mutual Recognition - PAINT-Consult

\zCONTACT POINTS FOR ADVICE ON MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES(The list is provided to assist pharmaceutical companies identifying a contact point <strong>for</strong> <strong>advice</strong> on the Mutual Recognition or Decentralised Procedures in each Member State. Thepersons listed should only be approached <strong>for</strong> general questions regarding the MRP or DCP and not <strong>for</strong> a particular application. For <strong>advice</strong> on particular applications please contactthe person in charge of that application in the respective Member State.)Doc. Ref.: CMDh/144/2000/Rev22August 2010COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILAUSTRIABELGIUMBULGARIACYPRUSCZECHREPUBLICChrista WIRTHUMER-HOCHEKristof LISZKAVanessa BINAMEFederal Agency <strong>for</strong> Safety in HealthCareAGES PharmMedLCMSchnirchgasse 9A-1030 VIENNAAgence Fédérale des Médicaments etdes Produits de Santé40 Place Victor HortaBoite 40B-1060 BRUSSELS+43 5 0555 36500 +43 5 0555 36508 christa.wirthumer-hoche@ages.at+43 5 0555 36610 +43 5 0555 36629 kristof.liszka@ages.at+32 2 524 81 70 +32 2 524 80 01 Vanessa.biname@afmps.beElena MASSEVABulgarian Drug Agency8, Damian Gurev Str.+359 2 89 03 494 +359 2 89 03 434 elena.masseva@bda.bgMariana TODOROVA1303 SofiaBulgaria +359 2 89 03 481 +359 2 89 03 434 mariana.todorova@bda.bgPanayiota KOKKINOUMinistry of Health+357 22 40 71 03 +357 22 40 71 49 pkokkinou@phs.moh.gov.cyIrene PericleousPharmaceutical Services(Validation of Applications) 7 Larnacos Avenue00 357 22 407 138 +357 22 40 71 49 ipericleous@phs.moh.gov.cySofia PETRIDOUCY – 1475 Nicosia(New Applications, Renewals Lefkosia +357 22 40 71 74 +357 22 40 71 49 spetridou@phs.moh.gov.cyand Variations)Monika KIŠACOVÁJitka VokrouhlickáState Institute <strong>for</strong> Drug ControlSrobárova 48CZ – 100 41 Praha 10+420 272 18 57 88 +420 271 732 377monika.kisacova@sukl.czjitka.vokrouhlicka@sukl.cz<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 1/6

COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILDENMARKESTONIAFINLANDFRANCEGERMANYGERMANY(sera, vaccines,bloodpreparations)GREECEHUNGARYJoan BOYE Danish Medicines Agency+45 44 88 9254 jbo@dkma.dkAxel Heides Gade 1+45 44 940 237Susanne LJØRRINGDK-2300 Copenhagen +45 44 88 92 09(Validations of variations)Margit PLAKSOState Agency of Medicines1 Nooruse Street+372 7 37 41 40 +372 7 37 41 42Triin MÄESALUEE-50411 TartuEstonia+372 7 37 41 40 +372 7 37 41 42Leena PIETILÄ(ATC:A,J,N,P,R,S,V)Marja HELENIUS(ATC:B,C,D,G,H,L,M)Alban DHANANIPeter BACHMANN(new applications)Susanne WINTERSCHEID(variations)Brigitte HAMMES(renewals)Katrin VÖLLERKaterina MORAITI (Head ofEvaluation Division)Catherine KEHAGIA(Head of Evaluation Section)Finnish Medicines AgencyP.O. Box 55(Mannerheimintie 103b )FIN - 00301 HELSINKIAgence française de sécurité sanitairedes produits de santé (Afssaps)143-147 bd Anatole FranceFR-93285 SAINT-DENIS CEDEXmrp@ravimiamet.ee+358 9 4733 4436 +358 9 4733 4260 leena.pietila@fimea.fi+358 9 4733 4235 +358 9 4733 4350 marja.helenius@fimea.fi+33 1 5587 3293 +33 1 5587 3292 Alban.dhanani@afssaps.sante.frFederal Institute <strong>for</strong> Drugs and +49 228 207 4163 +49 228 207 3452 peter.bachmann@bfarm.deMedical DevicesBfArM+49 228 207 4172 +49 228 207 4303 susanne.winterscheid@bfarm.deKurt-Georg Kiesinger-Allee 3D-53175 Bonn +49 228 207 4330 +49 228 207 4303 brigitte.hammes@bfarm.dePaul Ehrlich Institute (PEI)Bundesinstitut für Impfstoffe undbiomedizinische ArzneimittelPaul Ehrlich str. 51-59D - 63225 LANGENNational Organization <strong>for</strong> MedicinesRegistration DivisionMesogion Avenue 284HolargosGR - ATHENS 15562+49 6103 77 3902 +49 6103 77 1251 eu-cooperation@pei.de+302 10 650 7209 +302 10 654 7202 kmoraiti@eof.gr+ 302 10 650 7242 +302 10 654 7202 kkehagia@eof.grKatalin VARSÁNYI +361 8869 361 varsanyi.katalin@ogyi.huAnna TERZINNational Institute of PharmacyZrínyi U. 3H-1051Budapest+361 8869 300(general number)+36 1 318 11 67New applications:CMS: mrp-dcp-new-cms@ogyi.huRMS: mrp-dcp-new-rms@ogyi.huVariations:CMS: mrp-dcp-var-cms@ogyi.huRMS: mrp-dcp-var-rms@ogyi.hu<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 2/6

COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILICELANDJón Pétur Einarsson Iceland Medicines Agencyjpe@ima.is(CMDh Member)Eidistorg 13-15+354 520 2100 +354 561 2170Inga PALSDÓTTIR170 Seltjarnarnesinga@ima.is(CMDh Alternate)IcelandIRELANDMagdalena WIECKIEWICZmagdalena.wieckiewicz@imb.ieIE - RMSIrish Medicines BoardMagdalena WIECKIEWICZThe Earls<strong>for</strong>t Centremagdalena.wieckiewicz@imb.ieIE - CMS+353 1 676 4971 +353 1 676 8490Earls<strong>for</strong>t TerraceCathy WRIGHT (variations)cathy.wright@imb.ieIR - DUBLIN 2Aisling O’BRIEN (Renewals)aisling.obrien@imb.ieDr. Jayne CROWEjayne.crowe@imb.ieSandra PETRAGLIA(New Applications)+39 06 5978 4222 +39 06 5978 4248 s.petraglia@aifa.gov.itITALYLaura BRAGHIROLI(Post-marketing)Agenzia Italiana del FarmacoVia del Tritone, 181+39 06 5978 4383 +39 06 5978 4987 l.braghiroli@aifa.gov.itFrancesca CECCARINI IT - 00187 Roma(Validation and+39 06 5978 4281 +39 06 5978 4248 f.ceccarini@aifa.gov.itadministrative issues)LATVIAInta KurakinaState Agency of MedicinesJersikas iela 15+371 67 078 403 +371 67 078 428 inta.kurakina@zva.gov.lvRuta JasoteLV – 1003Riga+371 67 078 417 +371 67 078 428 ruta.jasote@zva.gov.lvLiechtensteinische LandesverwaltungAmt für GesundheitBrigitte.Batliner@ag.llv.liLIECHTENSTEIN Brigitte BATLINERAmtsapothekerinÄulestrasse 51+423 236 73 25 +423 236 73 50LITHUANIALUXEMBOURGDovile ZACHARKIENE(New applications andRenewals - Validation)Audrone PETRIKIENE(New applications andRenewals - Responses)Ruta BUCKIUNAITE(Variations)Jacqueline GENOUX-HAMES9490 VaduzPrincipality of LiechtensteinState Medicines Control AgencyŽirmūnų str. 139ALT-09120, VilniusLithuaniaDirection de La SantéVilla LouvignyDivision de la Pharmacie et desMedicamentsAllée MarconiL- 2120 Luxembourgalkvw@llv.li+370 5 2639974 dovilezacharkiene@vvkt.lt+370 5 263 92 65+370 37 792 552 audronepetrikiene@vvkt.lt+370 5 2639974+352.478.55.93 +352 26 20 01 47rutabuckiunaite@vvkt.ltJacqueline.genouxhames@ms.etat.luMedicines AuthorityMALTA Helen VELLALicensing Directorate+356 23 43 9158198 Rue D’Argens+356 23 43 91 10+356 23 43 9161GZR 03helen.vella@gov.mtGzira<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 3/6

COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILKora Doorduyn-van derStoepRonald JANSEN(Head of PharmacoTherapeutic Group: centralnervous system)+ 31 70 3567411 kh.doorduijn@cbg-meb.nl+31 70 356 70 67 rb.jansen@cbg-meb.nlTHENETHERLANDSFons WESSELING(Head of PharmacoTherapeutic Group:cardiovascular diseases,female hormones, diabetes)Sipko MÜLDER(Head of PharmacoTherapeutic Group:oncology, blood products)Medicines Evaluation BoardKalvermarkt 53P.O.Box 16229NL-2500 BE Den Haag+31 70 356 74 31 aim.wesseling@cbg-meb.nl+31 70 356 7515+31 70 356 74 21 hs.mulder@cbg-meb.nlBert HIEMSTRA(Head of PharmacoTherapeutic Group: vaccines,infectious disorders,endocrinology)+31 70 356 74 05 hs.hiemstra@cbg-meb.nlNORWAYPOLANDPORTUGALEmiel VAN GALEN (Head ofPharmaco TherapeuticGroup: Herbal andhomeopathic medicines)+31 70 356 7486e.v.galen@cbg-meb.nlMRP and DCP procedures +47 22 89 77 00 +47 22 89 75 21 mt@noma.noThe Norwegian Medicines AgencyInger HEGGEBØ Sven Oftedalsvei 8+47 22 89 77 44 +47 22 89 77 99 Inger.Heggebo@legemiddelverket.noN-0950 OsloSidsel Harby+47 22 89 77 29 +47 22 89 77 99 sidsel.harby@noma.noAnna Kalita Office <strong>for</strong> Registration of Medicinal +48 22 492 13 30 +48 22 492 13 79 anna.kalita@urpl.gov.plProducts, Medical Devices andAndrzej CzesławskiBiocidal Products+48 22 492 13 70 +48 22 492 13 79 andrzej.czeslawski@urpl.gov.pl(New Application)41 Zabkowska Str.Grzegorz CESSAK03-736 Warsaw, Poland +4822 492 13 60 +48 22 492 13 69 Grzegorz.cessak@urpl.gov.pl(Variations)Marta MARCELINO INFARMED(New Applications)Parque de Saúde de Lisboa+351 21 798 7234 +351 21 7987255 dam@infarmed.ptMargarida MORGADO Avenida do Brasil, n° 53(Variations & Renewals) P - 1700 LISBOA<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 4/6

COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILROMANIASLOVAKREPUBLICSLOVENIASPAINSWEDENDaniela VASILESCUNational Medicines Agency48, Av. Sanatescu011478 Bucharest+40 21 316 10 79 +40 21 316 34 97 daniela.vasilescu@anm.roRomaniaDagmar STARÁState Institute <strong>for</strong> Drug ControlKvetná 11+421 2 5070 1306 +421 2 55 56 41 27 dagmar.stara@sukl.skPeter POTÚČEKSK – 825 08Bratislava 26+421 2 5070 1103 +421 2 55 56 41 27 potucek@sukl.skSabina ZALAR(CMDh Member)+386 8 2000 500 sabina.zalar@jazmp.siAna VIDENSEKAgency <strong>for</strong> Medicinal Products andPODGORELECMedical Devices+386 8 2000 554 ana.vidensek@jazmp.si(CMDh Alternate & new of the Republic of Slovenia+386 8 2000 510MRP/DCP applications) Ptujska ulica 21Marko VITASSI-1000(new MRP/DCP applications) Ljubljana, Slovenia+386 8 2000 556 marko.vitas@jazmp.siLara CIBEJ(renewals & variations)+386 8 2000 516lara.cibej@jazmp.siMaria Luisa García-Vaquero(CMDh Member) + 34 91 822 50 47 +34 91 822 50 43 mgarciav@aemps.esAgencia Española del Medicamento yLaura OliveiraProductos Sanitarios(CMDh Alternate &newParque Empresarial Las Mercedes + 34 91 822 51 42 +34 91 822 50 43 loliveira@aemps.esMRP/DCP applications)Edificio 8C/Campezo 1,Carmen Serradilla28022 Madrid(new MRP/DCP applications) + 34 91 822 51 54 +34 91 822 50 43 cserradilla@aemps.esEspañaCristina Rodríguez Rojas(renewals & variations)Mr. Christer BACKMAN(CMDh Member)Ms. Christin OLOFSSON(CMDh Alternate)Mrs. Ann BYLUND(DCP - RMS)Mrs. Jennie TCHIKLADZÉ(MRP new applications -RMS)Mrs. Catarina WALLÉN(DCP & MRP newapplications - CMS)Ms. MagdalenaSÖDERBERG(Variations)Mrs. Helena MALM(Renewals)Medical Products AgencyDag Hammarskjölds väg 42S - 751 03 UPPSALA+ 34 91 822 58 11 +34 91 822 50 43 crodriguezr@aemps.es+46 18 17 26 19 christer.backman@mpa.se+46 18 17 26 71 christin.olofsson@mpa.se+46 18 17 42 40 ann.bylund@mpa.se+46 18 17 42 78 jennie.tchikladze@mpa.se+46 18 50 55 44+46 18 17 42 04 catarina.wallen@mpa.se+46 18 17 42 63 magdalena.soderberg@mpa.se+46 18 16 77 19helena.malm@mpa.se<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 5/6

COUNTRY CONTACT PERSON ADDRESS PHONE NR FAX NR E. MAILUNITEDKINGDOMMr. Leslie WHITBREADorLorraine GEEARSaadia SHARIEF(MR renewals and PSURs)Medicines and Healthcare productsRegulatory AgencyMarket Towers1 Nine Elms LaneUK - LONDON SW8 5NQ+44 20 7084 2451 or+44 20 7084 2477+44 20 7084 2709+44 20 7084 2147leslie.whitbread@mhra.gsi.gov.uklorraine.geear@mhra.gsi.gov.uk+44 20 7084 2951 +44 20 7084 2310 saadia.sharief@mhra.gsi.gov.ukEUROPEANAGENCYFlorence DELESKA +44 20 7 523 7375Matthias SENNWITZEuropean Medicines Agency+44 20 7 523 7634Annabel SPILL(Assistant)7, Westferry CircusCanary Wharf+44 20 7 523 7422UK - LONDON E14 4HBLaetitia Kpenou(Assistant)+44 20 7 523 7128+44 20 7418 8614 H-CMDhSecretariat@ema.europa.euEUROPEANCOMMISSIONJerica ZUPANDG Enterprise F2PharmaceuticalsRue de la Loi 200B-1049 Bruxelles+32 2 2961268 +32 2 2961520 jerica.zupan@ec.europa.eu<strong>Contact</strong> <strong>Points</strong> <strong>for</strong> <strong>advice</strong> on Mutual Recognition and Decentralised Procedures CMDh/144/2000/Rev22, August 2010 Page 6/6