Appendix V list of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 8 “Undesirable effects” of Smpc




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10 December 2015

EMA/67830/2013, Version 121

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

[Dutch]


Federaal agentschap voor geneesmiddelen en gezondheidsproducten

Afdeling Vigilantie

EUROSTATION II

Victor Hortaplein, 40/ 40

B-1060 Brussel

[For SmPC]

[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




Lietuva

VVKT prie LR SAM

Žirmūnų g. 139A

LT 09120, Vilnius

Tel: 8 800 73568

Faksas: 8 800 20131

El. paštas: NepageidaujamaR@vvkt.lt

Interneto svetainė: www.vvkt.lt




България

Изпълнителна агенция по лекарствата

ул. „Дамян Груев“ № 8

1303 София

Teл.: +359 2 8903417

уебсайт: www.bda.bg




Luxembourg/Luxemburg

Direction de la Santé – Division de la Pharmacie et des Médicaments

Villa Louvigny – Allée Marconi

L-2120 Luxembourg

Site internet: http://www.ms.public.lu/fr/activites/pharmacie-medicament/index.html


Česká republika

Státní ústav pro kontrolu léčiv

Šrobárova 48

100 41 Praha 10

Webové stránky: www.sukl.cz/nahlasit-nezadouci-ucinek


Magyarország

Országos Gyógyszerészeti és Élelmezés egészségügyi Intézet

Postafiók 450

H-1372 Budapest

Honlap: www.ogyei.gov.hu



Danmark

SundhedsstyrelsenLægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dkdkma@dkma.dk




Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal


Deutschland

Bundesinstitut für Arzneimittel und Medizinprodukte


Abt. Pharmakovigilanz
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




Nederland

Nederlands Bijwerkingen Centrum Lareb

Website: www.lareb.nl


Eesti

Ravimiamet

Koduleht: www.ravimiamet.ee



Norge

Statens legemiddelverk

[For SmPC]

Nettside: www.legemiddelverket.no/meldeskjema

[For package leaflet]

Nettside: www.legemiddelverket.no/pasientmelding




Ελλάδα

Εθνικός Οργανισμός Φαρμάκων

Μεσογείων 284

GR-15562 Χολαργός, Αθήνα

Τηλ: + 30 21 32040380/337

Φαξ: + 30 21 06549585

Ιστότοπος: http://www.eof.gr


Österreich

Bundesamt für Sicherheit im Gesundheitswesen

Traisengasse 5

1200 WIEN

ÖSTERREICH

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/





España

Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es




Polska

Departament Monitorowania Niepożądanych Działań Produktów Leczniczych 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

Agence nationale de sécurité du médicament et des produits de santé (Ansm)

et réseau des Centres Régionaux de Pharmacovigilance

Site internet: www.ansm.sante.fr





Portugal

INFARMED, I.P.


Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53

1749-004 Lisboa

Tel: +351 21 798 73 73

Linha do Medicamento: 800222444 (gratuita)


Fax: + 351 21 798 73 97
Sítio da internet: http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage

E-mail: farmacovigilancia@infarmed.pt




Hrvatska

Agencija za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju
Ksaverska cesta 4

10 000 Zagreb

Republika Hrvatska

Fax: + 385 (0)1 4884 110

Website: www.halmed.hr

e-mail: nuspojave@halmed.hr




România

Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale

Str. Aviator Sănătescu nr. 48, sector 1

Bucureşti 011478- RO

Tel: + 4 0757 117 259

Fax: +4 0213 163 497

e-mail: adr@anm.ro


Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:


medsafety@hpra.ie


Slovenija

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si





Ísland

til Lyfjastofnunar, www.lyfjastofnun.is




Slovenská republika

Štátny ústav pre kontrolu liečiv


Sekcia klinického skúšania liekov a farmakovigilancie
Kvetná 11
SK-825 08 Bratislava 26

Tel: + 421 2 507 01 206

Fax: + 421 2 507 01 237

internetová stránka: http://www.sukl.sk/sk/bezpecnost-liekov

e-mail: neziaduce.ucinky@sukl.sk


Italia

Agenzia Italiana del Farmaco

Sito web: http://www.agenziafarmaco.gov.it/it/responsabili



Suomi/Finland

[Finnish]

www-sivusto: www.fimea.fi

Lääkealan turvallisuus- ja kehittämiskeskus Fimea

Lääkkeiden haittavaikutusrekisteri

PL 55


00034 FIMEA
[Swedish]

webbplats: www.fimea.fi

Säkerhets- och utvecklingscentret för läkemedelsområdet Fimea

Biverkningsregistret

PB 55

00034 FIMEA




Κύπρος

Φαρμακευτικές Υπηρεσίες

Υπουργείο Υγείας

CY-1475 Λευκωσία

Φαξ: + 357 22608649

Ιστότοπος: www.moh.gov.cy/phs




Sverige

Läkemedelsverket

Box 26

751 03 Uppsala



Webbplats: www.lakemedelsverket.se


Latvija

Zāļu valsts aģentūra

Jersikas iela 15

Rīga, LV 1003

Tālr.: +371 67078400

Fakss: +371 67078428

Tīmekļa vietne: www.zva.gov.lv


United Kingdom

Yellow Card Scheme



Website: www.mhra.gov.uk/yellowcard




1 Changes implemented in the different revisions:

V.06: AT, IE and PL details updated (14 January 2014)

V.07: PL details updated (2 April 2014)

V.08: IE details updated (26 June 2014)

V.09: FI, MT and SL details updated (1 December 2014)

V.10: HR and HU details updated (1 April 2015)

V.11: BG, MT, PT and SK details updated (1 October 2015)

V.12: DK details updated (10 December 2015)





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