Download



18 June 2018

EMA/67830/2013, Version 16[1]

Scientific & Regulatory Management

APPENDIX V

List of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 4.8 “Undesirable effects” of SmPC and section 4 “Possible side effects” of package leaflet

No reference to the Appendix V should be included in the printed packaging materials. Only the actual details of the national reporting system (as listed within this Appendix V) of the concerned Member State(s) shall be displayed on the printed version.

Bracketing convention:

[text]: For guidance only. This text should not be included on the printed packaging materials.

|België/Belgique/Belgien |Lietuva |

|[Dutch] |VVKT prie LR SAM |

|Federaal agentschap voor geneesmiddelen en gezondheidsproducten |Žirmūnų g. 139A |

|Afdeling Vigilantie |LT 09120, Vilnius |

|EUROSTATION II |Tel: 8 800 73568 |

|Victor Hortaplein, 40/ 40 |Faksas: 8 800 20131 |

|B-1060 Brussel |El. paštas: NepageidaujamaR@vvkt.lt |

|[For SmPC] |Interneto svetainė: www.vvkt.lt |

|[Melding door gezondheidszorgbeoefenaars] | |

|Website: www.fagg.be | |

|e-mail: adversedrugreactions@fagg-afmps.be | |

|[For package leaflet] | |

|[Melding door patiënten] | |

|Website: www.fagg.be | |

|e-mail: patientinfo@fagg-afmps.be | |

| | |

|[French] | |

|Agence fédérale des médicaments et des produits de santé | |

|Division Vigilance | |

|EUROSTATION II | |

|Place Victor Horta, 40/ 40 | |

|B-1060 Bruxelles | |

|[For SmPC] | |

|[Notification par les professionnels de la santé] | |

|Site internet: www.afmps.be | |

|e-mail: adversedrugreactions@fagg-afmps.be | |

|[For package leaflet] | |

|[Notification par les patients] | |

|Site internet: www.afmps.be | |

|e-mail: patientinfo@fagg-afmps.be | |

| | |

|[German] | |

|Föderalagentur für Arzneimittel und Gesundheitsprodukte | |

|Abteilung Vigilanz | |

|EUROSTATION II | |

|Victor Hortaplein, 40/40 | |

|B-1060 BRUSSEL | |

|[For package leaflet] | |

|[Patientenmeldung] | |

|Website: www.fagg-afmps.be | |

|E-Mail: patientinfo@fagg-afmps.be | |

|България |Luxembourg/Luxemburg |

|Изпълнителна агенция по лекарствата |Direction de la Santé – Division de la Pharmacie et des Médicaments |

|ул. „Дамян Груев“ № 8 |Villa Louvigny – Allée Marconi |

|1303 София |L-2120 Luxembourg |

|Teл.: +359 2 8903417 |Site internet: |

|уебсайт: www.bda.bg |http://www.ms.public.lu/fr/activites/pharmacie-medicament/index.html |

|Česká republika |Magyarország |

|Státní ústav pro kontrolu léčiv |Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet |

|Šrobárova 48 |Postafiók 450 |

|100 41 Praha 10 |H-1372 Budapest |

|Webové stránky: www.sukl.cz/nahlasit-nezadouci-ucinek |Honlap: www.ogyei.gov.hu |

| | |

|Danmark |Malta |

|Lægemiddelstyrelsen |ADR Reporting |

|Axel Heides Gade 1 |Website: www.medicinesauthority.gov.mt/adrportal |

|DK-2300 København S | |

|Websted: www.meldenbivirkning.dk | |

|E-mail: dkma@dkma.dk | |

|Deutschland |Nederland |

|Bundesinstitut für Arzneimittel und Medizinprodukte |Nederlands Bijwerkingen Centrum Lareb |

|Abt. Pharmakovigilanz |Website: www.lareb.nl |

|Kurt-Georg-Kiesinger Allee 3 | |

|D-53175 Bonn | |

|Website: http://www.bfarm.de | |

| | |

|[For vaccines/biological medicinal products] | |

|Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel | |

|Paul-Ehrlich-Institut | |

|Paul-Ehrlich-Str. 51-59 | |

|63225 Langen | |

|Tel: +49 6103 77 0 | |

|Fax: +49 6103 77 1234 | |

|Website: www.pei.de | |

|Eesti |Norge |

|Ravimiamet |Statens legemiddelverk |

|Koduleht: www.ravimiamet.ee |[For SmPC] |

| |Nettside: www.legemiddelverket.no/meldeskjema |

| |[For package leaflet] |

| |Nettside: www.legemiddelverket.no/pasientmelding |

|Ελλάδα |Österreich |

|Εθνικός Οργανισμός Φαρμάκων |Bundesamt für Sicherheit im Gesundheitswesen |

|Μεσογείων 284 |Traisengasse 5 |

|GR-15562 Χολαργός, Αθήνα |1200 WIEN |

|Τηλ: + 30 21 32040380/337 |ÖSTERREICH |

|Φαξ: + 30 21 06549585 |Fax: + 43 (0) 50 555 36207 |

|Ιστότοπος: http://www.eof.gr |Website: http://www.basg.gv.at/ |

|España |Polska |

|Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: |Departament Monitorowania Niepożądanych Działań Produktów Leczniczych|

|www.notificaRAM.es |Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i |

| |Produktów Biobójczych |

| |Al. Jerozolimskie 181C |

| |PL-02 222 Warszawa |

| |Tel.: + 48 22 49 21 301 |

| |Faks: + 48 22 49 21 309 |

| |e-mail: ndl@urpl.gov.pl |

|France |Portugal |

|Agence nationale de sécurité du médicament et des produits de santé |INFARMED, I.P. |

|(Ansm) |Direção de Gestão do Risco de Medicamentos |

|et réseau des Centres Régionaux de Pharmacovigilance |Parque da Saúde de Lisboa, Av. Brasil 53 |

|Site internet: www.ansm.sante.fr |1749-004 Lisboa |

| |Tel: +351 21 798 73 73 |

| |Linha do Medicamento: 800222444 (gratuita) |

| |Fax: + 351 21 798 73 97 |

| |Sítio da internet: http://www.infarmed.pt/web/infarmed/submissaoram |

| |E-mail: farmacovigilancia@infarmed.pt |

|Hrvatska |România |

|Agencija za lijekove i medicinske proizvode (HALMED) |Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale |

|Internetska stranica: www.halmed.hr ili potražite HALMED aplikaciju |Str. Aviator Sănătescu nr. 48, sector 1 |

|putem Google Play ili Apple App Store trgovine |Bucureşti 011478- RO |

| |Tel: + 4 0757 117 259 |

| |Fax: +4 0213 163 497 |

| |e-mail: adr@anm.ro |

|Ireland |Slovenija |

|HPRA Pharmacovigilance | |

|Earlsfort Terrace |Javna agencija Republike Slovenije za zdravila in medicinske |

|IRL - Dublin 2 |pripomočke |

|Tel: +353 1 6764971 |Sektor za farmakovigilanco |

|Fax: +353 1 6762517 |Nacionalni center za farmakovigilanco |

|Website: www.hpra.ie |Slovenčeva ulica 22 |

|e-mail: medsafety@hpra.ie |SI-1000 Ljubljana |

| |Tel: +386 (0)8 2000 500 |

| |Faks: +386 (0)8 2000 510 |

| |e-pošta: h-farmakovigilanca@jazmp.si |

| |spletna stran: www.jazmp.si |

| | |

|Ísland |Slovenská republika |

|til Lyfjastofnunar, www.lyfjastofnun.is |Štátny ústav pre kontrolu liečiv |

| |Sekcia klinického skúšania liekov a farmakovigilancie |

| |Kvetná ul. 11 |

| |SK-825 08 Bratislava 26 |

| |Tel: + 421 2 507 01 206 |

| |Fax: + 421 2 507 01 237 |

| | |

| |e-mail: neziaduce.ucinky@sukl.sk |

| |Tlačivo na hlásenie nežiaduceho účinku je na webovej stránke |

| |www.sukl.sk v časti Lieky/Bezpečnosť liečiv |

| |Formulár na elektronické podávanie hlásení: |

| |https://portal.sukl.sk/eskadra/ |

| | |

|Italia |Suomi/Finland |

|Agenzia Italiana del Farmaco |[Finnish] |

|Sito web: |www-sivusto: www.fimea.fi |

| |Lääkealan turvallisuus- ja kehittämiskeskus Fimea |

|http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-|Lääkkeiden haittavaikutusrekisteri |

|reazione-avversa |PL 55 |

| |00034 FIMEA |

| | |

| |[Swedish] |

| |webbplats: www.fimea.fi |

| |Säkerhets- och utvecklingscentret för läkemedelsområdet Fimea |

| |Biverkningsregistret |

| |PB 55 |

| |00034 FIMEA |

|Κύπρος |Sverige |

|Φαρμακευτικές Υπηρεσίες |Läkemedelsverket |

|Υπουργείο Υγείας |Box 26 |

|CY-1475 Λευκωσία |751 03 Uppsala |

|Φαξ: + 357 22608649 |Webbplats: www.lakemedelsverket.se |

|Ιστότοπος: www.moh.gov.cy/phs | |

|Latvija |United Kingdom |

|Zāļu valsts aģentūra |Yellow Card Scheme |

|Jersikas iela 15 |Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in|

|Rīga, LV 1003 |the Google Play or Apple App Store |

|Tīmekļa vietne: www.zva.gov.lv | |

-----------------------

[1] Changes implemented in the different revisions:

V.13: HR, IT and LV details updated (2 May 2017)

V.14: HR, SL and UK details updated (4 July 2017)

V.15: IT, PT and SK details updated (11 December 2017)

V.16: PT details updated (18 June 2018)

Download