This page contains information on fees requested for application of marketing authorisation dossiers in each Member State.
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European Union
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Address for Advice European Medicines Agency 7 Westferry Circus Canary Wharf GB – LONDON E14 4HB Tel: +44 207 418 8400 Fax: +44 207 418 8416, 418 84 47 Method of payment The EMEA must receive the full application fee in EUROs (net of all bank charges) in order for an application to be validated. Therefore it is advisable to initiate the bank transfer approximately 1 week in advance of the submission of the application. The EMEA banking reference is as follows: Lloyds TSB Plc City International Branch, PO Box 72, Bailey Drive, Gillingham Business Park, Kent, ME8 0LS Sort code: 30-00-02 A/C: 59007357 in the name of EMEA "application fees" account. Swift code: Loyd GB 2L CTY More information on the Application fees in the Centralised Procedure is available on the EMEA Website www.emea.eu.int/htms/general/admin/fees/feesfaq.htm |
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Austria
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Published National Rules Click here Address for Advice Bundesamt für Sicherheit im Gesundheitswesen Shnirchgasse 9 A- 1030 Wien Tel : +43 (1) 50555-36670 Fax : + 43 (1) 50555 - 36679 Payable to Bank Austria-Creditanstalt Account n° 50670871 619 BLZ : 12000 IBAN : AT971200050670871619 BIC/SWIFT : BKAUATWW Method of payment Only the bank account, in € (Euros). Cheques are not accepted. The name of the applicant, the name of the product, the reference number and the customer number must be stated. No fees should be paid in advance of the procedure. |
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Belgium
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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 De Algemene Farmaceutische Inspectie – Vergoedingen Inspection générale de la Pharmacie – Redevances C.A.E./R.A.C. B-1010 Brussel Tel. (32) (2) 210 63 85, Fax. (32) (2) 210 49 22 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
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Address for Advice Cyprus Director of Veterinary Services 5 Larnaca Avenue Flat 201, 202; Block A 2101 Nicosia The receipt of fees must be supplied at the same time as the submission of the dossier. |
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Czech republic
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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: uskvbl@uskvbl.cz 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
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Published National Rules For non immunological veterinary products : Kostenverordnung für die Zulassung von Arzneimitteln durch das Bundesinstitut für Arzneimittel und Medizinprodukte und das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Bundesanzeiger Verlagsgesellschaft m.b.H. P.O. Box 100534 D-50445 Köln Address for Advice Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Abteilung 3 Diedersdorfer Weg 1 D-12277 Berlin Tel: +49 1888 84 12 1210 Fax: +491888 84 12 2956 Payable to Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) 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 For immunological veterinary products : 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 1205 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
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Published National Rules Indenrigs- og Sundhedsministeriets bekendtgřrelse nr. 1129 af 15.12.2003 om afgifter for lćgemidler og lćgemiddelvirksomheder Address for Advice Lćgemiddelstyrelsen Axel Heides gade 1 DK-2300 Křbenhavn S Tel: +45 44 88 95 95 Payable to Lćgemiddelstyrelsen Axel Heides gade 1 DK-2300 Křbenhavn S Tel: +45 44 88 95 95 The fee will be invoiced by the Danish Medicines Agency Method of payment Postal cheque service 9 18 4295 From other EC countries: Jyske Bank Vesterbrogade 9 DK-1780 Křbenhavn V, Danmark reg. no. 8109 account no. 100835-9 or reg.no. 5010 account no. 122275-5 S.W.I.F.T./BIC code: JYBADKKK |
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Estonia
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Payable to Estonia State Fee payable to: Maksu- ja Tolliamet (Estonian Tax and Customs Board) Hansapank Account No : 22 10 13 26 43 40 Liivalaia 8, 15040 Tallinn, Estonia SWIFT code: HABAEE2X Or Ühispank Account No : 10 05 20 32 26 20 03 Tornimäe 2, 15010 Tallinn, Estonia SWIFT code: EEUHEE2X Reference number 1299085 Method of payment The name of the product and the reference number must be stated. The state fee has to be paid prior the submission of the application. Proof of payment of the state fee should be enclosed to the application. |
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Finland
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Published National Rules Decision of the Ministry of Social Affairs and Health concerning activities of the National Agency for Medicines subject to fees Address for Advice Available in internet www.nam.fi and also from: National Agency for Medicines Department of General Affairs Mannerheimintie 103 b 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 Leonia Bank plc., preferably with transfer (swift code PSPBFIHH). The date of payment of the fee should be noted on the application and proof of payment, e.g. 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 and method of processing (national procedure/mutual recognition). |
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France
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Published National Rules Décret n° 2005-141 du 17 février 2005 pris pour l'application de l'article L.5141-8 du code de la santé publique Address for Advice AFSSA - ANMV Agence Nationale du Médicament Vétérinaire Javené BP 90203 F-35302 Fougčres Tel: +33 2 99 94 78 60 Fax: +33 2 99 94 78 64 E-mail: enreg@anmv.afssa.fr Method of payment Cheques should be made payable to Agent comptable de l'AFSSA |
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Greece
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Published National Rules Ministerial Decree N°Y6a/11094/97 published in the Official Gazette 235/B/11-3-98. National Drug Organization 284 Messogion Avenue Holargos GR-15562 Athens Address for Advice Evaluation Division, Section of Veterinary Products, EOF Mesogion Avenue 284 Holargos GR Athens 15562 Tel: +30 210 650 72 77 or 6507278 or 6507387 Fax: +30 210 653 75 91 Payable to Bank of Greece (to the account of the National Drug Organization) 26303/8 Foreign Exchange Department – Section C 21 Panepistimiou Avenue GR-10250 Athens Payment to be made on application. Proof of payment is necessary. |
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Hungary
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Published National Rules 65/2003. (VI. 19.) FVM rendelet az egyes állategészségügyi igazgatási szolgáltatások díjáról szóló 46/1999. (V. 19.) FVM rendelet módosításáról Website of the Institute for Veterinary Medicinal Products www.ivmp.gov.hu Payable to Hungarian State Treasury account no.: 10032000-0174 0204-00000000 Method of payment Proof of payment must accompany the application. Cost of the quality control of samples should be payed additionally by request. |
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Iceland
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Published National Rules Reglugerđ um skráningu-, árgjöld og önnur leyfisgjöld. Heilbrigđis- og tryggingamálaráđuneytiđ Laugavegi 116 105 Reykjavík Iceland. Address for Advice Lyfjastofnun P.O. Box 180 Eiđistorgi 13-15 170 Seltjarnarnes Iceland tel. +354 5202100 fax number: +354 5612170 email : lyfjastofnun@lyfjastofnun.is website : www.lyfjastofnun.is Payable to The Central Bank of Iceland Bank account no.: 0001-26-025017, Ríkisféhirđir, kt. 540269-6459 Swift address is: sislisre In receipt of an application an ivoice is sent to applicant Deposit into bankaccount. Cheques not accepted. All remittances should quote invoice number, the name and address of the applicant and the name of the product. Proof of payment is required before applications can be processed. |
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Ireland
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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 7836 Payable to Irish Medicines Board Block A, Earlsfort Centre Earlsfort Terrace, IRL-Dublin 2 Tel: +353 1 676 4971; fax: +353 1 676 7836 Method of payment Payment must be made at time of application, by any of the following methods: 1. Electronic Fund Transfer (EFT) to: A/C No 33712185 / Sort code: 93-10-12 IBAN: IE 54 AIBK 931012 33712185 A/C Name: Irish Medicines Board Bank: Allied Irish Bank 1-3 Lower Baggot Street IRL-Dublin 2 Proof of payment must accompany application 2. Irish cheque in € (Euros) drawn on an Irish Bank 3. Bank draft drawn on an Irish Bank in € |
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Italy
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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 Salute – Direzione Generale della Sanitŕ Veterinaria e degli Alimenti – UFF. XI Piazzale G. Marconi 25 I-00144 Roma Tel: +39 06 59 94 65 84 Fax: +39 06 59 94 69 49, 59 94 62 17 or 59 94 66 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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Latvia
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Published National Rules Order No. 228 of Ministry of Agriculture of 18. June, 2004 and Price Current for fee of Food and Veterinary Service Payable to EUR account: The Treasury Republic of Latvia, identification number: 90000050138 Beneficiary: Food and Veterinary Service the Republic of Latvia, identification number – 90000064301 Beneficiary’s bank: Parekss banka Branch “Citadele” Kr. Valdemara iela 1b, Riga, LV-1805 Bank code: 310101708 SWIFT code: PARXLV22 Accont number: LV 54TREL 049102000000B Method of payment An invoice will be sent upon receipt of the application. No payment should be made in advance. Please make sure that the whole amount of the will be credited to our account net of any charges from the issuing or receiving bank. |
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Liechtenstein
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Published National Rules Pending |
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Lithuania
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Published National Rules Order No. 709 of State Food and Veterinary Service of 16 December, 2002 Address for Advice Mrs Kristina Sudikiene Phone : +370 37 268 129 e-mail : kristinak@vet.lt Payable to Lithuanian State Inspection on Veterinary Preparations NORD/LB Lietuva, Kaunas Branch Vilnius, LITHUANIA, SWIFT:AGBL LT 2X EUR Account number: LT984010042500030252 Method of payment In receipt of an application an invoice is sent to applicant. Cheques not accepted. All remittances should quote the name and address of the applicant and the name of the product. Please make sure that the whole amount of the will be credited to our account net of any charges from the issuing or receiving bank. |
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Luxemburg
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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 Villa Louvigny Division de la Pharmacie et des Médicaments Allee Marconi L-2120 Luxembourg Tel: +352 478 55 94 fax: +352 26 20 01 40 or 26 20 01 47 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. Tel. : +352 4785594 |
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Malta
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Published National Rules Pending |
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Norway
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Published National Rules Forskrifter om legemidler Statens legemiddelverk Sven Oftedals vei 8 NO-0950 OSLO Payable to Statens legemiddelverk Sven Oftedals vei 8 NO-0950 OSLO Tel: +47 22 89 77 00 Den Norske Bank P.O. Box 1171 NO-0107 Oslo Bank account no.: 7694 05 00903 SWIFT: DNBANOKK |
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Poland
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Published National Rules Rozporzadzenie Ministra Zdrowia z dnia 30 lipca 2003 w sprawie sposobu ustalania i uiszczania oplat zwiazanych z dopuszczeniem do obrotu produktu leczniczego weterynaryjnego (Dziennik Ustaw No 156 z 2003 r. poz 1530 i 1531). Payable to Narodowy Bank Polski Warszawa Bank account no.: 30 1010 1010 0094 1022 3100 0000 Kod BIC NBP- NBPLPLPW Method of payment The receipt of fees must be supplied at the same time as the submission of the dossier. Cheques are not accepted |
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Portugal
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Published National Rules Non-immunologicals veterinary medicinal products : Portaria Nş586/99 de 2 de Agosto Diario da República – I – Série B, Nş178, 02-08-99, Immunologicals veterinary medicanal products : Decreto-Lei N° 245/2000 de 29 de Setembro Diario da República – I – Série A, Nş226, 29-09-2000 Diario da República – I – Série B, 91/12/19, available from the address for advice on fees Address for Advice DGV Direcçăo-Geral de Veterinária Lg. Academia Nacional de Belas Artes 2 P-1294-105 Lisboa Tel: +351 21 323 95 33; fax: +351 21 323 95 65 Method of payment Payment must be made at the time of the application submission, by any of the following methods: - Cash – treasurer’s office of DGV - Portuguese cheques in € (Euros) made payable to “ Direcçăo Geral de Veterinária” and send to the DGV treasurer’s office (Tesouraria da Direcçăo Geral de Veterinária) - Bank deposit/transfer to: Bank - TESOURO Account name: Direcçăo Geral de Veterinária NIB – 0035 0697 0080 1871 026 67 IBAN – PT 500035 0697 0080 1871 026 67 SWIFT BIC CODE – TESPPTP1 The amount must be the exact one (net of all bank charges) It is advisable to initiate the bank transfer approximately 1 week in advance of the submission of the application. Proof of payment (a copy of the deposit/transfer slip)* must accompany the application and shall also be sent to: Tesouraria da DGV Lg. Academia Nacional de Belas Artes 2 1294-105 Lisboa Tel: +351 21 3239500 Fax: +351 21 3239 *Proof of payment must quote the Portaria Nş586/99 de 2/8 (Non-immunologicals) or the DL N° 245/2000 de 29/9( Immunologicals), the name of the product, the type of application (MA, Type I variation…etc) and, in case of mutual recognition procedure, the MR application number. |
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Slovak Republic
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Published National Rules Zákon c.140/98 Z.z. o lieku a zdravotníckych pomôckach a Zákon c. 145/95 Z.z. o správnych poplatkoch, v znení neskorších predpisov. Address for Advice Ústav štátnej kontroly veterinárnych biopreparátov a lieciv (Institute for State Control of Veterinary Biologicals and Medicaments) Biovetská 34 949 01 Nitra Tel.: +421 37 6515 501-3 Fax: +421 37 6517 915 E-mail: uskvbl@uskvbl.sk Website: www.uskvbl.sk Payable to BANK NAME: National Bank of Slovakia, Bratislava, Slovakia SWIFT: NBSBSKBX Beneficiary’s account No.: SK 6107200382600001257852 Beneficiary: STATNA POKLADNICA resp. STATE TREASURY Receiver account No.: 7000078109/8180 (write this number to payment specification) Receiver address: Ústav štátnej kontroly veterinárnych biopreparátov a lieciv Biovetská 34, 949 01 Nitra, Slovakia Remittance Information: pmt title: 347 inv. No.: ...... attn.: Mrs. Péteryová Method of payment The receipt of fees must be supplied at the same time as the submission of the dossier. Cheques are not accepted |
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Slovenia
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Published National Rules Pravilnik o višini stoškov za preskušanje zdravil, izdajo dovoljenja za promet z zdravili za uporabo v veterinarski medicini in za strokovni nadzor Address for Advice arszmp@gov.si Payable to Bank name: Banka Slovenije Branch address: Slovenska 35 Town/City: Ljubljana Post code: 1000 Account number: 01100-1000621284 Ref. No.: 11-27146-7141009 IBAN: SI5601100-1000621284 SWIFT code (BIC): BSLJSI2X Fees have to be paid prior to submission of the application. |
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Spain
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Published National Rules "Ley 66/1997 de 30 de Diciembre 1997 de Medidas Fiscales, Administrativas y del Orden Social". Address for Advice Ministerio de Sanidad y Consumo Agencia Espańola de Medicamentos y Productos Sanitarios Alcalá 56 E-28071 Madrid Fax: +34 91 8225443 Payable to TESORO PUBLICO. Agencia Espańola del Medicamento Method of payment By bank transfer trough bank account n° 0182 9071 03 0203977511 BANCO BILBAO VIZCAYA (BBVA) Paseo del Prado 18-20 E-28014 MADRID Each application should be accompaigned by a payment voucher. |
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Sweden
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Published National Rules State Control of Medicinal Products (Fees) Ordinance (1993:595) Ordinance on change in the ordinance (1993:595) on fees for the governmental control of medicinal products (SFS 1997:961 and 1998:1813 Medical Products Agency’s provision and guidelines (LVFS 1995:12) Fritzes SE-106 47 Stockholm Tel: +46 8 690 90 90 Method of payment An invoice will be sent upon receipt of the application. No payment should be made in advance |
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The Netherlands
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Published National Rules College ter Beoordeling van Ggeneesmiddelen Medicines Evaluation Board Unit Veterinary Medicinal Products Postbus 289 NL-6700 AG Wageningen Tel: +31 317 46 57 30 Fax: +31 317 42 31 93 E-mail: brd@minlnv.nl Website: www.BRD.AGRO.NL 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. |
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United Kingdom
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Published National Rules The Medicines (Products for Animal Use – Fees) (Amendments) Regulation 2004; S.I. 2004/2750 Her Majesty’s Stationery Office P.O. Box 276 London SW8 2DR United Kingdom Cost: Ł 4.70 ISBN Number 0-11-049982-4 Address for Advice Veterinary Medicines Directorate Finance Revenue Section Woodham Lane New Haw Nr. Addlestone Surrey KT15 3LS United Kingdom Tel: +44 1932 33 83 78 Fax: +44 1932 33 66 18 Payable to Veterinary Medicines Directorate Cashier Room 231 Woodham Lane New Haw Nr. Addlestone Surrey KT15 3LS United Kingdom Tel: +44 1932 33 83 85 fax: +44 1932 33 66 18 Method of payment Cheques should be made payable to “Defra – Veterinary Medicines Directorate” Payment by automated credit transfer should quote a/c no. 65639138 – sort code 60 23 40 International Payments should quote |
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