CMDv-GUI-26 EMA/CMDv/101114/2012 ADDRESSES FOR DELIVERY OF THE DOSSIER FOR PRE- AND POST-AUTHORISATION PROCEDURES (paper and e-submissions) Please select the filter arrow in order to search for a specific country or type of submission COUNTRY TYPE OF Submission ADDRESS CONTACT E-MAIL PHONE NR FAX NR Advice on MRP/DCP - Eugen OBERMAYR, Austrian Medicines and Medical Ines LINDNER: Devices Agency Dpt. Veterinary Medicinal Products eugen.obermayr@ages. Traisengasse 5 at +43 50 555-36670 Austria General A-1200 Wien www.basg.gv.at [email protected] +43 50 555-36598 Austrian Medicines and Medical Devices Agency Dpt. Veterinary Medicinal Products Email address for pre- Traisengasse 5 Austria authorisation submissions A-1200 Wien www.basg.gv.at [email protected] Austrian Medicines and Medical Devices Agency Submission of Dpt. Veterinary Medicinal Products translations in Email address for pre- Traisengasse 5 MRP/DCP procedures Austria authorisation submissions A-1200 Wien www.basg.gv.at [email protected] Austrian Medicines and Medical Devices Agency Dpt. Veterinary Medicinal Products Email address for post- Traisengasse 5 Austria authorisation submissions A-1200 Wien www.basg.gv.at [email protected] Submission of Austrian Medicines and Medical translations in MRP/DCP Devices Agency procedures, variations Dpt. Veterinary Medicinal Products and renewals Email address for post- Traisengasse 5 Austria authorisation submissions A-1200 Wien www.basg.gv.at [email protected] Austrian Medicines and Medical Advice on technical Devices Agency issues: Dpt. Veterinary Medicinal Products Traisengasse 5 martin.hofstaetter@ages Austria Queries on e-submissions A-1200 Wien www.basg.gv.at .at Federal Agency for Medicines & Health Products DG PRE – Veterinary Division Eurostation block II Place Victor Horta 40, box 40 Belgium General 1060 Brussels [email protected] 0032 2 524 80 00 0032 2 524 80 01 Federal Agency for Medicines & Health Products DG PRE – Veterinary Division Eurostation block II Email address for pre- Place Victor Horta 40, box 40 pre.authorisation.v@fa Belgium authorisation submissions 1060 Brussels gg-afmps.be 0032 2 524 80 00 0032 2 524 80 01 Federal Agency for Medicines & Health Products DG PRE – Veterinary Division Eurostation block II Email address for post- Place Victor Horta 40, box 40 post.authorisation.v@f Belgium authorisation submissions 1060 Brussels agg-afmps.be 0032 2 524 80 00 0032 2 524 80 01 National Veterinary Service Control of VMP Department +35929159820 15 A ”Pencho Slaveykov” Blvd. (General)/ +359 2 +35929549593 Bulgaria General 1606 Sofia 915 98 69 (General)/+359 2 915 98 69 National Veterinary Service Control of VMP Department +35929159820 Email address for pre- 15 A ”Pencho Slaveykov” Blvd. (General)/ +359 2 +35929549593 Bulgaria authorisation submissions 1606 Sofia 915 98 69 (General)/+359 2 915 98 69 National Veterinary Service Control of VMP Department +35929159820 Email address for post- 15 A ”Pencho Slaveykov” Blvd. (General)/ +359 2 +35929549593 Bulgaria authorisation submissions 1606 Sofia 915 98 69 (General)/+359 2 915 98 69 Ministry of Agriculture and Environment Veterinary Services 1417 Cyprus General Nicosia Ministry of Agriculture and Environment Veterinary Services Email address for pre- 1417 Cyprus authorisation submissions Nicosia Ministry of Agriculture and Environment Veterinary Services Email address for post- 1417 Cyprus authorisation submissions Nicosia y Savska cesta 143 National, MRP/DCP Croatia General Zagreb 10000 y Svjetlana Terzić Ph.D. [email protected] +38516123609 +38516190840 Email address for pre- Savska cesta 143 National, MRP/DCP Croatia authorisation submissions Zagreb 10000 y Svjetlana Terzić Ph.D. [email protected] +38516123609 +38516190840 Email address for post- Savska cesta 143 National, MRP/DCP Croatia authorisation submissions Zagreb 10000 Svjetlana Terzić Ph.D. [email protected] +38516123609 +38516190840 Ústav pro státní kontrolu veterinárních biopreparátů a léčiv Hudcova 56a +420 541 518 Czech Republic General 621 00 Brno – Medlánky,CZ www.uskvbl.cz [email protected] 222/211 +420 541 210 026 Ústav pro státní kontrolu National Procedures veterinárních biopreparátů a léčiv (+ during procedure Email address for pre- Hudcova 56a issues) Czech Republic authorisation submissions 621 00 Brno – Medlánky,CZ Mrs.Věra Morávková [email protected] +420 541 518 264 +420 541 210 026 Ústav pro státní kontrolu MRP/DCP(+during veterinárních biopreparátů a léčiv procedure issues) Email address for pre- Hudcova 56a Mrs.Iveta Obrovská, [email protected] +420 541 518 295 Czech Republic authorisation submissions 621 00 Brno – Medlánky,CZ Mr.Daniel Dušek [email protected] +420 541 518 261 +420 541 210 026 Ústav pro státní kontrolu veterinárních biopreparátů a léčiv National Procedures Email address for post- Hudcova 56a Czech Republic authorisation submissions 621 00 Brno – Medlánky,CZ Mrs.Věra Morávková [email protected] +420 541 518 264 +420 541 210 026 Ústav pro státní kontrolu MR/DC procedures veterinárních biopreparátů a léčiv Email address for post- Hudcova 56a Mrs.Iveta Obrovská, [email protected] +420 541 518 295 Czech Republic authorisation submissions 621 00 Brno – Medlánky,CZ Mr.Daniel Dušek [email protected] +420 541 518 261 +420 541 210 026 Ústav pro státní kontrolu Pharmacovigilance veterinárních biopreparátů a léčiv issue/PSUR Email address for post- Hudcova 56a Czech Republic authorisation submissions 621 00 Brno – Medlánky,CZ Mrs. Eva Zubrová [email protected] +420 541 518 272 +420 541 210 026 Lægemiddelstyrelsen Axel Heides Gade 1 Denmark Queries on e-submissions DK – 2300 København S [email protected] +45 44 88 95 95 +45 44 88 95 99 Contact to coordinator during Supplemental procedure: information only: Lægemiddelstyrelsen GOD- [email protected] Email address for pre- Axel Heides Gade 1 afdelingspostkasse Common format Denmark authorisation submissions DK – 2300 København S @dkma.dk requirements apply +45 44 88 95 95 +45 44 88 95 99 Contact to coordinator during Supplemental procedure: information only: Lægemiddelstyrelsen GOD- [email protected] Email address for post- Axel Heides Gade 1 afdelingspostkasse Common format Denmark authorisation submissions DK – 2300 København S @dkma.dk requirements apply +45 44 88 95 95 +45 44 88 95 99 State Agency of Medicines Nooruse 1 Estonia General 50411 Tartu [email protected] +372 7 374 140 +372 7 374 142 Applications: documentation@ravimia met.ee; Response documents for State Agency of Medicines MRP/DCP, translations Email address for pre- Nooruse 1 of final PI: Estonia authorisation submissions 50411 Tartu [email protected] +372 7 374 140 +372 7 374 142 documentation@ravimia met.ee; response documents for State Agency of Medicines MRP/DCP, translations Email address for post- Nooruse 1 of final PI: Estonia authorisation submissions 50411 Tartu [email protected] +372 7 374 140 +372 7 374 142 Finnish Medicines Agency Marketing Authorisations Mannerheimintie 103 b P.O. Box 55 FIN-00301 Helsinki Delivery address : Nauvontie 4 Finland General FIN-00300 Helsinki +358 9 4733 41 +358 9 4733 4355 Finnish Medicines Agency Marketing Authorisations Mannerheimintie 103 b P.O. Box 55 FIN-00301 Helsinki Delivery address : Email address for pre- Nauvontie 4 [email protected] Finland authorisation submissions FIN-00300 Helsinki i +358 9 4733 41 +358 9 4733 4355 Finnish Medicines Agency Marketing Authorisations Mannerheimintie 103 b P.O. Box 55 FIN-00301 Helsinki Delivery address : Email address for post- Nauvontie 4 Finland authorisation submissions FIN-00300 Helsinki +358 9 4733 41 +358 9 4733 4355 ANSES – ANMV Agence Nationale du Médicament Vétérinaire 8 rue Claude Bourgelat Parc d'Activités de la Grande Marche Javené BP 90203 France General 35302 FOUGERES Cedex [email protected] +33 2 99 94 78 60 +33 2 99 94 78 64 ANSES – ANMV Agence Nationale du Médicament Vétérinaire 8 rue Claude Bourgelat Parc d'Activités de la Grande Marche Javené Communication during Email address for pre- BP 90203 validation France authorisation submissions 35302 FOUGERES Cedex [email protected] +33 2 99 94 78 60 +33 2 99 94 78 64 ANSES – ANMV Agence Nationale du Médicament Vétérinaire 8 rue Claude Bourgelat [email protected] Parc d'Activités de la Grande Marche (pharmaceuticals) Javené [email protected] Email address for pre- BP 90203 (immunologicals) France authorisation submissions 35302 FOUGERES Cedex +33 2 99 94 78 60 +33 2 99 94 78 64 ANSES – ANMV Agence Nationale du Médicament Vétérinaire 8 rue Claude Bourgelat [email protected] Parc d'Activités de la Grande Marche (pharmaceuticals) Javené [email protected] Email address for post- BP 90203 (immunologicals) France authorisation submissions 35302 FOUGERES Cedex +33 2 99 94 78 60 +33 2 99 94 78 64 ANSES – ANMV Agence Nationale du Médicament Vétérinaire 8 rue Claude Bourgelat Parc d'Activités de la Grande Marche Communication during Javené validation and Email address for post- BP 90203 preparation of decision France authorisation submissions 35302 FOUGERES Cedex [email protected] +33 2 99 94 78 60 +33 2 99 94 78 64 Paul Ehrlich Institut Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Germany Paul-Ehrlich Strasse 51-59 [email protected] (immunologicals) General D-63225 Langen e +49 6103 770 +49 6103 77 1234 Note: Eudralink submission of initial applications for a marketing authorisation are not accepted; 1 CD resp. DVD required in a Paul Ehrlich Institut format in acc. with the Bundesinstitut für Impfstoffe und GL biomedizinische Arzneimittel Germany Email address for pre- Paul-Ehrlich