Plasma Master File (PMF) coordinators list

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Applicants should submit their application to the PMF contact point, with the exception of the Netherlands*.
Please note that for countries where only PMF Coordinator is nominated, the PMF documentation should be addressed to his/her attention.

* Dr. Pieter de Graeff - College ter Beoordeling van Geneesmiddelen – Graadt van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS

Austria

Coordinator

Name
Ilona G. Reischl
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, Austria
Tel.
+43 50555 36820
Fax.
+43 50555 36809
Email
ilona.reischl@ages.at

Contact Point

Name
Martina Joseph
Affiliation
BASG - Bundesamt für Sicherheit im Gesundheitswesen
Address
Traisengasse 5, A- 1200 Vienna, Austria
Tel.
+43 50 555 365 83
Fax.
+43 50 555 365 89
Email
martina.joseph@ages.at

Belgium

Coordinator

Name
Koenraad Brusselmans
Affiliation
Wetenschappelijk Instituut Volksgezondheid
Address
Juliette Wytsmanstraat 14, 14 Rue Juliette Wytsman, 1050 Brussel - Bruxelles, Belgium
Tel.
0032 2 642 56 52
Fax.
0032 2 642 52 10
Email
koen.brusselmans@wiv-isp.be

Contact Point

Bulgaria

Coordinator

Name
Lyudmil Antonov
Affiliation
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Address
8, Damyan Gruev str., 1303 Sofia, Bulgaria
Tel.
+359 2 8903493
Fax.
+359 2 8903434
Email
lyudmil.antonov@bda.bg

Contact Point

Croatia

Coordinator

Name
Tamara Mandusic Nazor
Affiliation
Agencija za Lijekove i Medicinske Proizvode
Address
Ksaverska cesta 4, 10000 Zagreb, CROATIA
Tel.
+385 14884 253
Fax.
+385 1 4884110
Email
tamara.mandusic@halmed.hr

Contact Point

Cyprus

Coordinator

Name
Maria Vassiliou
Affiliation
Ministry of Health
Address
Pharmaceutical Services, 1475 Nicosia, Cyprus
Tel.
+357 22 407133
Fax.
+357 22 407149
Email
mvasiliou@phs.moh.gov.cy

Contact Point

Czech Republic

Coordinator

Name
Barbora Ladinova
Title
Pharmaceutical Assessor
Affiliation
Státní ústav pro kontrolu léčiv
Address
Srobarova 48, 100 41 Prague, Czech Republic
Tel.
+420 2 72185235
Fax.
+420 2 67310104
Email
barbora.ladinova@sukl.cz

Contact Point

Denmark

Coordinator

Name
Nanna Aaby Kruse
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, Denmark
Tel.
+45 44 889294
Fax.
+45 44 889232
Email
nak@dkma.dk

Contact Point

Name
Lotte Dahl
Affiliation
Danish Medicines Agency
Address
Axel Heides Gade 1, 2300 København S, Denmark
Tel.
+45 44 889553
Fax.
+45 44889599
Email
loda@dkma.dk

Finland

Coordinator

Name
Sirkku Saarela
Title
Senior Researcher
Affiliation
Lääkealan turvallisuus- ja kehittämiskeskus
Address
P.O.Box 55, Mannerheiminitie 103b, 00034 - Fimea Helsinki, Finland
Tel.
+358 29522 3429
Fax.
+358 29522 3015
Email
sirkku.saarela@fimea.fi

Contact Point

France

Coordinator

Name
Marie-Christine Annequin
Affiliation
Agence nationale de sécurité du médicament et des produits de santé
Address
143-147 Bvd Anatole France, 93285 Saint-Denis Cedex, France
Tel.
+33 1 55873508
Fax.
+33 1 55873492
Email
marie-christine.annequin@ansm.sante.fr

Contact Point

Germany

Coordinator

Name
Heidi Meyer
Affiliation
Paul-Ehrlich-Institut
Address
Postfach 1740, 63207 Langen, Germany
Tel.
+49 6103 773106
Fax.
+49 6103 77123
Email
meyhe@pei.de

Contact Point

Name
Johannes Dodt
Affiliation
Paul-Ehrlich-Institut
Address
Postfach 1740, 63207 Langen, Germany
Tel.
+49 6103 772 713
Fax.
+49 6103 771 265
Email
dodjo@pei.de

Greece

Coordinator

Name
Asterios Tsiftsoglou
Affiliation
Aristotle University of Thessaloniki
Address
School of Pharmacy, University Campus, 54124 Thessaloniki, Greece
Tel.
+30 23 10997631
Fax.
+30 23 10997618
Email
tsif@pharm.auth.gr

Contact Point

Hungary

Coordinator

Name
Erika Szabo
Affiliation
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet
Address
Zrínyi U. 3, 1051 Budapest, Hungary
Tel.
+36 1 8869331
Fax.
+36 18 869460
Email
szabo.erika@ogyei.gov.hu

Contact Point

Iceland

Coordinator

Name
Ulrike Muus
Title
Scientist (Quality Assessor) and Project Manager in DC- and MR-Procedures
Affiliation
Lyfjastofnun
Address
Vínlandsleið 14, IS-113 Reykjavík, Iceland
Tel.
+354 520 2147
Email
Ulrike.Muus@lyfjastofnun.is

Contact Point

Ireland

Coordinator

Name
Una Moore
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, Ireland
Tel.
+353 1 6764971
Fax.
+353 1 6767836
Email
una.moore@hpra.ie

Contact Point

Name
Niamh Curran
Affiliation
An tÚdarás Rialála Táirgí Sláinte
Address
Kevin O'Malley House, The Earlsfort Centre, Earlsfort Terrace, Dublin, 2, Ireland
Tel.
+353 1676 4971
Fax.
+353 1 6767836
Email
niamh.curran@hpra.ie

Italy

Coordinator

Name
Carlo Pini
Affiliation
Istituto Superiore di Sanità
Address
Viale Regina Elena, 299, 00161, Roma, Italy
Tel.
+39 064 990 2683
Fax.
+39 064 938 7115
Email
carlo.pini@iss.it

Contact Point

Name
Karen Cristiano
Affiliation
Istituto Superiore di Sanità
Address
Viale Regina Elena, 299, 00161, Roma, Italy
Tel.
+39 064 9902346
Fax.
+39 064 9902964
Email
karen.cristiano@iss.it

Lithuania

Coordinator

Name
Vitalis Briedis
Affiliation
Lithuanian University of Health Sciences
Address
Eiveniu 4, 2nd floor, LT-50161 Kaunas, Lithuania
Tel.
+37 037 327248
Email
VitalisBriedis@vvkt.lt

Contact Point

Luxembourg

Coordinator

Name
Jean-Louis Robert
Affiliation
Jean Louis Robert - CxMP WP
Address
2 AM Groussfeld, L-5239 Sandweiler, Luxembourg
Email
jean-louis.robert.ema@pt.lu

Contact Point

Malta

Coordinator

Name
John Joseph Borg
Affiliation
Awtorità dwar il-Mediċini
Address
Sir Temi Zammit Buildings, SGN 3000 San Gwann, MALTA
Tel.
+356 23 439129
Fax.
+356 23 439158
Email
john-joseph.borg@gov.mt

Contact Point

Netherlands

Coordinator

Name
R. Martijn Van der Plas
Affiliation
College ter Beoordeling van Geneesmiddelen
Address
P.O. Box 8275, Graadt van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS
Tel.
+31 88 224 8204
Fax.
+31 88 224 8001
Email
rm.vd.plas@cbg-meb.nl

Contact Point

Name
Marja van de Bovenkamp
Affiliation
College ter Beoordeling van Geneesmiddelen
Address
P.O Box 8275, 3503 Utrecht RG , Netherlands
Tel.
+31 882248042
Email
M.vd.Bovenkamp@cbg-meb.nl

Norway

Coordinator

Name
Therese Solstad Saunders
Title
Scientific Officer
Affiliation
Statens legemiddelverk
Address
Postbox 6167 , Etterstad, 0602 Oslo, Norway
Tel.
+47 228 97700
Email
Therese.Saunders@noma.no

Contact Point

Poland

Coordinator

Name
Magdalena Szymaniak
Title
Biological assessor
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
Warsaw, POLAND
Tel.
+48 606 253686
Fax.
+48 22 4921389
Email
magdalena.szymaniak@urpl.gov.pl

Contact Point

Name
Katarzyna Regulska
Title
Blood products assessor
Affiliation
Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych
Address
03-736 Warsaw, POLAND
Tel.
+48 22 492 12 24
Fax.
+48 22 492 11 09
Email
katarzyna.regulska@urpl.gov.pl

Portugal

Coordinator

Name
Margarida Menezes-Ferreira
Affiliation
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Address
Parque de Saúde de Lisboa, Avenida do Brasil, 53, 1749-004 Lisboa, Portugal
Tel.
+351 21 7985251
Fax.
+351 21 7987369
Email
margarida.menezes@infarmed.pt

Contact Point

Name
Angelo Ferreira da Silva
Affiliation
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Address
Parque de Saúde de Lisboa, Avenida do Brasil, 53, 1749-004 Lisboa, Portugal
Tel.
+351 21 798 7362
Fax.
+351 21 798 7369
Email
angelo.silva@infarmed.pt

Romania

Coordinator

Name
Mirela Tavakol
Title
Senior Biologist
Affiliation
Agentia Natională a Medicamentului şi a Dispozitivelor Medicale
Address
Str. Aviator Sănătescu 48, Sector 1, 011478 Bucharest, Romania
Tel.
+40 2 131102
Fax.
+40 2 13162178
Email
mirela.barsan@anm.ro

Contact Point

Spain

Coordinator

Name
Marcos Timón
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, Spain
Tel.
+34 91 8225826
Fax.
+34 91 8225892
Email
mtimon@aemps.es

Contact Point

Name
Maria Chamorro Somoza Diaz-Sarmiento
Title
External Expert
Affiliation
Agencia Española de Medicamentos y Productos Sanitarios
Address
Parque Empresarial Las Mercedes , Edificio 8 , C/Campezo 1, 28022 Madrid, Spain
Tel.
+34 91 8225860
Fax.
+34 91 8225243
Email
msomoza@aemps.es

Sweden

Coordinator

Name
Mats Welin
Affiliation
Läkemedelsverket
Address
Dag Hammarskjölds väg 42, 75237 Uppsala, SWEDEN
Tel.
+46 18 172615
Fax.
+46 18 548566
Email
mats.welin@mpa.se

Contact Point

Name
Eva M Lindberg
Affiliation
Läkemedelsverket
Address
Box 26, 751 03 Uppsala, SWEDEN
Tel.
+46 18 174626
Fax.
+46 18 548566
Email
eva.lindberg@mpa.se

United Kingdom

Coordinator

Name
Michael Udell
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, United Kingdom
Tel.
+44 203 0807707
Email
michael.udell@mhra.gsi.gov.uk

Contact Point

Name
Maria de Africa Mora
Title
Intern - Administrator
Affiliation
Medicines and Healthcare Products Regulatory Agency
Address
151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, United Kingdom
Tel.
+44 20 30806411
Email
MariaDeAfrica.MoraGarcia@mhra.gsi.gov.uk