ANNEX IV CONTACT LIST FOR THE NETWORK OF COMPETENT AUTHORITIES FOR IVMPS

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1 ANNEX IV CONTACT LIST FOR THE NETWORK OF COMPETENT AUTHORITIES FOR IVMPS Annex to procedure for application of Article 81 and procedure for application of Article 82 in the European Community For the purpose of rapid information exchange and exchange of certificates of noncompliance the Authorities or their officially designated representatives should be contacted. (compiled s list at the end of the document) Contacts European Community Member States AUSTRIA Austrian Federal Office for Safety in Health Care (BASG) Possingergasse 38 AT-1160 WIEN AUSTRIA Contact: Dieter PULLIRSCH Phone: Fax : omcl-at@ages.at SCIENSANO Rue Juliette Wytsman 14 B-1050 BRUSSELS BELGIUM Contact: Ignacio GISBERT-ALGABA Phone : Fax : vbrn@sciensano.be Institute for Control of Veterinary Medicinal Products 7 Shose Bankya Str. BG 1331 SOFIA BULGARIA Contact: Vladislav PETKOV Phone: Fax: vpetkov@itp.bg BELGIUM BULGARIA Officially designated to act on behalf of the CA

2 Croatian Veterinary Institute Zagreb Savska cesta 143 Zagreb CROATIA Contact: TBD Phone: + Fax: + Contacts CROATIA CYPRUS Veterinary Services Ministry of Agriculture, Veterinary Public Health Division CY-1417 Nicosia CYPRUS Contact: Apostolos MAZERIS Phone: Fax: amazeris@vs.moa.gov.cy CZECH REPUBLIC Institute for State Control of Veterinary Biologicals and Medicaments Hudcova, 56a RTC BRNO Contact: Dana PIVODOVA Phone: Fax: batchrelease@uskvbl.cz Danish Health and Medicines Axel Heides Gade 1 DK-2300 KOBENHAVN S DENMARK Contact: Leif Kongskov Larsen Phone : Fax : biologi@dkma.dk State Agency of Medicines 1 Noouse Street ZES TARTU ESTONIA DENMARK ESTONIA Contact: Eveli HOLST Phone : / Fax : Eveli.Holst@ravimiamet.ee / info@ravimiamet.ee - - -

3 FINLAND EVIRA Veterinary Virology Mustialankatu 3 FIN HELSINKI FINLAND Contact: Niina TAMMIRANTA Phone : Fax : niina.tammiranta@evira.fi / batch.release@evira.fi FRANCE Anses - ANMV 8 rue Claude Bourgelat - Parc d'activités de la Grande Marche - Javené - CS Fougères FRANCE Contact: Mikaëlle SACHET / Jocelyne VERDON Phone: Fax: mickaelle.sachet@anses.fr / ucqm@anses.fr GERMANY Paul-Ehrlich-Institut Paul Ehrlich Str D LANGEN GERMANY Contact: Michael MUEHLEBACH Phone : Fax : veterinaermedizin@pei.de National Organisation for Medicines 284 Mesogeion Avenue GR HOLARGOS GREECE Contact: Vassilis VIOLAKIS Phone : , -221 Fax : vviolakis@eof.gr NFCSO Directorate of Veterinary Medicinal Products Szallas u.8, H-1107 BUDAPEST HUNGARY Contact: Katalin FABIAN Phone: / Fax: fabiank@nebih.gov.hu GREECE HUNGARY - -

4 Irish Medicines Board Kevin O Malley House Earlsfort Terrace DUBLIN 2 REPUBLIC OF IRELAND Contact: Kevin O DONNELL Phone : Fax : kevin.odonnell@imb.ie Contacts IRELAND ITALY Ministry of Health Dipartimento della Sanità Pubblica veterinaria, della Sicurezza Alimentare e degli organi Collegiali per la Tutela della Salute Direzione Generale della Sanità Animale e dei Farmaci veterinari Ufficio 05 Viale Giorgio Ribotta 5 I ROMA ITALY Contact: Virgilio DONINI Phone : Fax : v.donini@sanita.it LATVIA Division of the Marketing Authorisation for Veterinary Medicinal Products Food and Veterinary Service Peldu Str.30 LV-1050 RIGA LATVIA Contact: Santa ZIRNITE Phone: Fax: santa.zirnite@pvd.gov.lv LITHUANIA State Food and Veterinary Service Republic of Lithuania Siesiku str. 19 LT Vilnius LITHUANIA Contact: Sigitas SIRIUKAITIS Phone: Fax: sigitas.siriukaitis@vmvt.lt - - -

5 Laboratoire National de Santé Service de Chimie Pharmaceutique 1, Rue Louis Rech L-3555 Dudelange LUXEMBOURG Contacts LUXEMBOURG Contact: Claude Marson Phone: (Secrétariat)/ (Claude Marson) Fax: Ministry of Rural Affairs and Environment Food and Veterinary Regulatory Division Albertown GBY-MARSA MALTA Contact: Stephan PSAILA Phone: Fax: MALTA NETHERLANDS Medicines Evaluation Board-Veterinary Medicinal Products Unit Graadt van Roggenweg 500 NL-3531 AH Utrecht NETHERLANDS Contact: Tom VAN DER HEIJDEN Phone : Fax : t.vd.heijden@cbg-meb.nl National Veterinary Research Institute 57 Partyzantow Avenue PULAWY POLAND Contact: Krzysztof NIEMCZUK / Jacek KUZMAK Phone: Fax: sekretariat@piwet.pulawy.pl POLAND - - Officially designated to act on behalf of the CA

6 Ministério da Agricultura e do Mar Direção Geral de Alimentação e Veterinária Campo Grande nº LISBOA PORTUGAL PORTUGAL - Contact: Maria Lucilia AZEVEDO MENDES Phone: Fax: maria.mendes@dgav.pt. ROMANIA Institute for Control of Veterinary Biological Products and Medicines 39, Dududui Street, Sector 6 R BUCHAREST ROMANIA Contact: Steluta ROSU Phone : Fax : icbmv@icbmv.ro SLOVAK REPUBLIC Institute for State Control of Vet. Biologicals and Medicines USKVBL Biovetska, 34 P.O. Box 52c SK NITRA SLOVAK REPUBLIC Contact: Katarína MASSANYIOVA Phone: (or 507) Fax: massanyiova@uskvbl.sk National Laboratory of Health, Environment and Food Prvomajska ulica 1 SI-2000 Maribor SLOVENIA Contact: Petra RIZMAL Phone: Fax: posebna.kontrola@nlzoh.si SLOVENIA

7 SPAIN Agencia Española de Medicamentos y Productos Sanitarios Calle Campezo 1 E MADRID SPAIN Contact: Dra Consuelo RUBIO Phone : Fax : vet.vaccines.spain@aemps.es Medical Products Agency Dag Hammarskjölds väg 42 Box 26 SE UPPSALA SWEDEN SWEDEN Contact: Karl-Henrik JÖNSSON / Peter STJARNKVIST Phone : Fax : karl-henrik.jonsson@mpa.se / peter.stjarnkvist@mpa.se Veterinary Medicines Directorate Woodham Lane New Haw Addlestone SURREY KT15 3LS UNITED KINGDOM Contact: Rory COONEY / Javier POZO Phone : / Fax: none available r.cooney@vmd.defra.gsi.gov.uk, j.pozo@vmd.defra.gsi.gov.uk UNITED KINGDOM - -

8 Institute for Experimental Pathology University of Iceland, Keldur 8540 IS-128 REYKJAVIK ICELAND Contact: Eggert GUNNARSSON Phone: Fax: eggun@hi.is Norwegian Medicines Agency Sven Oftedals vei 6 8 NO-0950 OSLO NORWAY Contact: Ane Marit KVINGEDAL Phone : Fax : ane.kvingedal@legemiddelverket.no EEA MEMBER STATES ICELAND NORWAY Mutually Recognised Partners SWITZERLAND Institut für Viruskrankheiten and Immunoprophylaxe (IVI) Sensemattstrasse 293 CH-3147 MITTELHÄUSERN SWITZERLAND Contact: Hans-Peter OTTIGER / Nathalie ALBRECHT Phone : Fax : vaccinovigilance@ivi.admin.ch - - European Commission DG Health and Consumers * European Commission Unit D6 - Medicinal Products Safety, Quality and Efficacy DG Health and Consumers DM24 02/38 B 1049 BRUSSELS Official Contact BELGIUM Contact: TBA Phone : Fax : SANTE-PHARMACEUTICALS-B4@ec.europa.eu

9 European Medicines Agency * EMA - European Medicines Agency 30 Churchill Place, Canary Wharf, London E14 5EU United Kingdom Contact: Dr. Miia Jakava-Viljanen Telephone: +44 (0) Fax: miia.jakava-viljanen@ema.europa.eu Official Contact European Directorate for the Quality of Medicines * EDQM DBO, Batch Release Section 7 Allee Kastner CS F STRASBOURG Official Contact FRANCE Contact: Karl-Heinz BUCHHEIT Phone : +33 (0) Fax : +33 (0) BatchReleaseVet@edqm.eu * Note: EC, EMA and EDQM contacts should receive all information circulated to the CAs or their designated representatives Compiled s list omcl-at@ages.at; vbrn@sciensano.be; vpetkov@itp.bg; amazeris@vs.moa.gov.cy; batchrelease@uskvbl.cz; biologi@dkma.dk; Eveli.Holst@ravimiamet.ee; info@ravimiamet.ee; niina.tammiranta@evira.fi; batch.release@evira.fi; ucqm@anses.fr mickaelle.sachet@anses.fr; veterinaermedizin@pei.de; vviolakis@eof.gr; fabiank@nebih.gov.hu; kevin.odonnell@imb.ie; v.donini@sanita.it; tatjana.mihailina@pvd.gov.lv; sigitas.siriukaitis@vmvt.lt; claude.marson@lns.etat.lu; stephan.psaila@gov.mt; t.vd.heijden@cbg-meb.nl; sekretariat@piwet.pulawy.pl; maria.mendes@dgav.pt; icbmv@icbmv.ro; massanyiova@uskvbl.sk; posebna.kontrola@nlzoh.si; vet.vaccines.spain@aemps.es; karlhenrik.jonsson@mpa.se; r.cooney@vmd.defra.gsi.gov.uk; j.pozo@vmd.defra.gsi.gov.uk; eggun@hi.is; ane.kvingedal@legemiddelverket.no; vaccinovigilance@ivi.admin.ch; SANTE-PHARMACEUTICALS- B4@ec.europa.eu; martin.ilott@ema.europa.eu; qdefect@ema.europa.eu; BatchReleaseVet@edqm.eu; peter.stjarnkvist@mpa.se

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