This page contains information on fees requested for application of marketing authorisation dossiers in each Member State.
European Union
Directory… Address for Advice
European Agency for the Evaluation of Medicinal Products
7 Westferry Circus
Canary Wharf
UKLondon E14 4HB
Telephone : +44 -20-7418 8400
Fax (veterinary unit) : +44 -20-7418 8447
NB : Fees paid to the EMEA and connected to mutual recognition procedures would only relate to an arbitration
Method of payment
In the name of EMEA “application fees” account
Bank: Lloyds Bank Plc
City International Branch
72 Lombard Street
London EC3P 3BT
Account: : 59007357
Sort Code: 30-12-18
Payments must be net of all bank charges. Please instruct your bank accordingly.
The fees payable to the EMEA are stated in the Commission Regulation (EC) No 297/95.
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Belgium
Directory… Published National Rules
K.B. van 3.7.1969 betreffende de registratie van geneesmiddelen
A.R. du 3.7.1969 relatif ŕ l’enregistrement des médicaments
(text available only in Dutch and French)
Address for Advice
Federal Public Service Health, Food Chain Safety and Environment
Directorate-General Public Health Protection: Medicinal Products
Secretary of Medicine Commission
Bischoffsheim 33, 1st floor
B-1000 Brussels
Tel. (32) (2) 227 55 10 ; Fax. (32) (2) 227 55 31
Payable to
Directoraat-generaal Geneesmiddelen – Vergoedingen
Direction Générale Médicaments – Redevances
C.A.E./R.A.C.
B-1010 Brussels
Tel. (32) (2) 210 63 85 ; Fax. (32) (2) 210 64 25
On postal account number (PRK-CCP) 679-2005949-86
Method of payment
Only on the postal account, in € (Euros)
Cheques are not accepted
The name of the applicant and the name of the product must be stated
Proof of payment is required before an application can be accepted
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Cyprus
Directory… Published National Rules
Pending
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Czech republic
Directory… Published National Rules
Zákon c. 79/1997 Sb., o lécivech, ve znení pozdejších predpisu a Zákon císlo 368/1992 Sb., o správních poplatcích, ve znení pozdejších predpisu. (Act No 79/1997 Coll., on Pharmaceuticals, as results from the changes made by the Act. No. 129/2003 Coll. and Act No. 368/1992 Coll., on Administrative fees, as last amended.)
USKVBL/UST – 2/2003 – Správní poplatky a úhrady nákladu za odborné úkony provádené na žádost (USKVBL/UST – 2/2003 – Administrative fees and payments of costs of specialised tasks performed on request.)
Address for Advice
Ústav pro státní kontrolu veterinárních biopreparátu a léciv
Hudcova 56a
621 00 Brno – Medlánky
Tel: +420-541 210 022-024
Fax: +420-541 210 026
E-mail: [email protected]
Website: www.uskvbl.cz
Payable to
Ceská národní banka
Rooseveltova 18
631 32 Brno
Account number: 35-31229641/0710
SWIFT CODE: CNBACZPP
Method of payment
Administrative fees:
A fee stamp or a bank transfer – account number: 3711-31229641/0710
Payments of costs:
Bank transfer – account number: 35-31229641/0710
Name and address of the bank:
Ceská národní banka
Rooseveltova 18
631 32 Brno
SWIFT CODE: CNBACZPP
Payments should be made in advance of the procedure. A proof of payment must accompany the application.
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Germany
Directory… Published National Rules
Kostenverordnung für die Zulassung von Arzneimitteln durch das Bundesinstitut für Arzneimittel und Medizinprodukte und das Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin.
Bundesanzeiger Verlagsgesellschaft m.b.H.
P.O. Box 100534
D-50445 Köln
Address for Advice
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Abteilung 3
Diedersdorfer Weg 1
D-12277 Berlin
Tel: (49) (30) 84 12 1210; fax: (49) (30) 84 12 2956
Payable to
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Abteilung 3
Diedersdorfer Weg 1
D-12277 Berlin
Method of payment
Payment on request according to calculation of cost (Kostenbescheid). The Kostenbescheidnummer must always be indicated
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Published National Rules
Tierimpfstoff-Kosten-Verordnung
Bundesanzeiger Verlagsgesellschaft m.b.H.
P.O. Box 100534
D-50445 Köln
Address for Advice
Paul-Ehrlich-Institut
Bundesarnt für Sera und Impfstoffe
Paul-Ehrlich-Strasse 51-59
D-63225 Langen
Tel: (49) 6103 77 7450; fax: (49) 6103 77 123
Payable to
Paul-Ehrlich-Institut
Bundesarnt für Sera und Impfstoffe
Paul-Ehrlich-Strasse 51-59
D-63225 Langen
Method of payment
Payment on request according to calculation of cost (Kostenbescheid). The Kostenbescheidnummer must always be indicated.
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Denmark
Directory… Published National Rules
As of 1 January 2004, the fees for medicinal products and pharmaceutical companies wer changed, cf. executive order on fees for medicinal products and pharmaceutical companies (EO No 1129 of 15 December 2003). You can find more information on the homepage of the Secretariat for Legal Information
Address for Advice
The Danish Medicines Agency,
Axel Heides Gade 1,
DK-2300 Copenhagen S, Denmark
or our website http://www.dkma.dk, with specific page.
Payable to
The Danish Medicines Agency
Axel Heides Gade 1,
DK-2300 Copenhagen S
Denmark
Method of payment
Jyske Bank
DK-1780
Copenhagen V
Denmark
Teles 27340.
SWIFT address : JYBADKKK
Account nr. : 8109 1008359
IBAN : DK8481090001008359
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Estonia
Directory… Published National Rules
Pending
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Finland
Directory… Published National Rules
Decision of the Ministry of Social Affairs and Health concerning activities of the National Agency for Medicines subject to fees, No 709 as amended N8143/1998
Address for Advice
National Agency for Medicines
Department of General Affairs
P.O. Box 55
FIN-00301 Helsinki
Tel: (358) 9 473 341; fax: (358) 9 4733 42 67
Payable to
National Agency for Medicines
Marketing Authorisations Method of Payment:
Account no. 800014-21 979 of Postipankki Ltd., preferably with transfer (S.W.I.F.T. code PSPBFIHH). A copy of the payment slip shall be appended to the application. The post-giro must contain the name proposed for the product, its strength and pharmaceutical form and the name of the applicant.
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France
Directory… Published National Rules
Décret n° 94-601 du 12 juillet 1994 portant application de l’article L-617-5 du Code de la Santé Publique
Address for Advice
AFSSA
Agence Nationale du Médicament Vétérinaire
BP 90203
F-35302 Fougčres CEDEX
Tel: (33) 2 99 94 78 82; fax: (33) 2 99 94 78 88;
Method of payment
Cheques should be made payable to Agent comptable de l’AFSSA
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Greece
Directory… Published National Rules
Click here
Bundesministerium für Gesundheit und Frauen
Abteilung III/A/5a
Radetzkystrasse 2
A-1010 Wien
Tel: (43) 1 71100 4835
Fax: (43) 1 7134404 1681
Address for Advice
Bundesministerium für Gesundheit und Frauen
Abteilung III/A/5a
Radetzkystrasse 2
A-1010 Wien
Tel: (43) 1 71100 4429
Fax: (43) 1 7134404 1681
Payable to
Bundesministerium für Gesundheit und Frauen
P.S.K. Account No 50 70 066 – BLZ. 60000
SWIFT CODE “OPSKATWW”
IBAN CODE AT53 6000 0000 0507 0066
Method of payment
Only on the postal account.
Cheques are not accepted.
The name of the applicant, the name of the product and the reference number (GZ) must be stated.
No fees should be paid in advance of the procedure.
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Published National Rules
Ministerial Decision Y6a/11094/98
Address for Advice
National Organisation for Medicines
Veterinary Section
Mesogion Av, 284
Holargos
15562 Athens
Greece
Tel : +30 210 65 07 277
Fax : +30 210 65 37 591
Payable to
Bank of Greece
IBAN : GR5301000240000000000263038
BIC : BNGRGRAA
Foreign Exchange Department, Section C
Panepistimiou Av, 21
10250 Athens
Greece
Method of payment
A copy of the receipt should accompany the file of the application.
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Hungary
Directory… Published National Rules
Decree No. 65/2003. (VI. 19.) FVM of the Ministry of Agriculture and Rural Development
Address for Advice
[email protected]
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Iceland
Directory… Published National Rules
Pending
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Ireland
Directory… Address for Advice
Veterinary Section
Irish Medicines Board
Block A, Earlsfort Centre
Earlsfort Terrace,
IRL-Dublin 2
Tel: (353) (1) 676 4971; fax (353) (1) 676 8490
Payable to
Irish Medicines Board
Block A, Earlsfort Centre
Earlsfort Terrace,
IRL-Dublin 2
Tel: (353) (1) 676 4971; fax: (353) (1) 676 8490
Method of payment
Payment must be made at time of application, by any of the following methods:
- Electronic Fund Transfer (EFT) to:
A/C No 67105552 / Sort code: 90/00/84
A/C Name: Irish Medicines Board
Bank: Bank of Ireland
39 St. Stephen’s Green
IRL-Dublin 2
Proof of payment must accompany application
- Irish cheque in IRŁ drawn on an Irish Bank
- Bank draft drawn on an Irish Bank in IRŁ
For immunological Veterinary Medicinal Products
Veterinary Division,
Department of Agriculture, Food and Forestry,
Kildare Street
IRL-Dublin 2
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Italy
Directory… Published National Rules
Registration Taxes
1) Ministry of Health Decree of 19 July 1993 published in the “Gazzetta Ufficiale” no. 172 of 24 July 1993.
2) Decreto legislativo of 24 February 1997 n. 47, published in the “Supplemento ordinario alle Gazzetta Ufficiale” n. 54 of 6 March 1997.
Address for Advice
Ministero della Sanitŕ
Dipartimento degli Alimenti e Nutrizione e della Sanitŕ Pubblica Veterinaria
UFF. XI
Piazzale G. Marconi 25
I-00144 Roma
Phone: (39) (6) 59 94 35 79;
Fax: (39) (6) 59 94 32 17 or 59 94 36 76
Method of payment
Payment must be made through Postal Giro No 12453015 registered to TESOREIA PROVINCIALE DI VITERBO.
Proof of payment must accompany the dossier. Cheques are not acccepted.
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Liechtenstein
Directory… Published National Rules
Pending
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Lithuania
Directory… Published National Rules
Document available on request
Address for Advice
Mrs Kristina Sudikiene
Phone : +370 37 268 129
e-mail : [email protected]
Payable to
NORD/LB Lietuva, Kaunas Branch
Vilnius, LITHUANIA
SWIFT : AGBL LT 2X
EUR Account number : LT984010045200030252
Method of payment
Bank transfer
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Luxemburg
Directory… Published National Rules
Rčglement Grand-Ducal du 24.12.93 fixant les droits dus pour la mise sur le marché des médicaments
Address for Advice
Division de la Pharmacie et des Médicaments
Rue C. M. Spoo, 10
L-2546 Luxemburg
Tel: (352) 478 55 94; fax: (352) 22 44 58
Payable to
Administration de l’Enregistrement et des Domaines
Plateau du St. Esprit
L-2010 Luxemburg
Method of payment
Proof of payment must accompany the dossier.
Payment must be made through Postal Account No 77 33 70. Cheques are not accepted. Contact person: Mr. Carlo Scholl, Inspector.
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Malta
Directory… Published National Rules
Pending
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Norway
Directory… Published National Rules
http://www.noma.no/reg/fees.htm
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Poland
Directory… Published National Rules
Pending
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Portugal
Directory… Published National Rules
Portaria no 1207/91 de 19 de Dezembro
Diario da República – I – Série B, 91/12/19, available from the address for advice on fees
Address for Advice
Direcçăo-Geral de Veterinária
Lg. Academia Nacional de Belas Artes 2
P-1294 Lisboa CODEX
Tel: (351) (1) 323 95 33; fax: (351) (1) 323 95 65; telex: 14818 VETERI-P
Payable to
(Bank): Caixa Geral de Depósitos
(Account name): Commissăo Técnica dos Medicamentos Veterinários
(Account number): 0697/801871-026
Confirmation of deposit should be sent to:
Direcçăo-Geral de Veterinária
Lg. Academia Nacional de Belas Artes 2
P-1294 Lisboa CODEX
Tel: (351) (1) 323 95 33; fax: (351) (1) 323
Method of payment
Proof of payment must accompany the copy of the dossier deposited in Direcçăo Geral de Veterinária. Cheques are not accepted.
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Slovak Republic
Directory… Published National Rules
Pending
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Slovenia
Directory… Published National Rules
Pending
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Spain
Directory… Published National Rules
“Ley 66/1997 de 30 de Diciembre 1997 de Medidas Fiscales, Administrativas y del Orden Social”.
Address for Advice
Subdirección General de Sanidad Animal
Calle Velázquez, 147
E-28002 Madrid
Fax: (34) (1) 347 82 99 or 347 83 41
Payable to
Servicios Facultativos Veterinarios
Method of payment
Through bank account: “Tasa 21.10 Servicios Facultativos Veterinarios” – del Banco Espańol de Crédito
Glorieta del Emperador Carlos V
E-28012 Madrid
Each application should be accompanied by the original payment voucher
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Sweden
Directory… Published National Rules
http://www.mpa.se/eng/regulatory/fees/index.shtml#Contact
Method of payment
Postal Giro account no. 78 80 56-0
Bank transfer : Bank account no 5439-1001225
Skandinaviska Enskilda Banken
SE-106 40 Stockholm
Sweden
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The Netherlands
Directory… Published National Rules
Bureau Registratie Diergeneesmiddelen
Postbus 289
NL-6700 AG Wageningen
Tel: (31) (0)317 47 54 91; fax: (31) (0)317 42 31 93
Payable to
Bureau Registratie Diergeneesmiddelen
NL-6700 AG Wageningen
Method of payment
Payment must be made through Postal Cheque Account no. 10 41 759. Cheques are not accepted. Remittances should quote the product name and the Dutch application number
IBAN: NL89 PSTB 0001 041759
BIC: PSTBNL21
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United Kingdom
Directory… Published National Rules
The Medicines (Products for Animal Use – Fees) (Amendments) Regulations 2000; S.I. 2000/2250
HMSO Bookshops
Cost: Ł2.50 + postage
ISBN Number 0-11-079702-7
Address for Advice
Fees Section
Veterinary Medicines Directorate
Woodham Lane
New Haw
UK-Addlestone KT15 3LS, Surrey
Tel: +44 (0) 1932 338372
Payable to
Cashier
Veterinary Medicines Directorate
Woodham Lane
New Haw
UK-Addlestone KT15 3LS, Surrey
Method of payment
Cheques should be made payable to “MAFF – Veterinary Medicines Directorate”
Payment by automated credit transfer should quote
a/c no. 65639138 – sort code 60 23 40
All remittances must be made in pounds sterling