10 March 2020

EMA/67830/2013, Version 191

Human Medicines Division

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.

1
Changes implemented in the different revisions:
V.16: PT details updated (18 June 2018)
V.17: BE, DE, DK, FR, IE, LU, PT details updated (15 June 2019)
V.18: LU and IT details updated (16 August 2019)
V.19: RO and SK details updated (3 March 2020)

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition
period, i.e. until 31.12.2020.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
 België/Belgique/Belgien Lietuva
[Dutch] VVKT prie LR SAM
Federaal agentschap voor geneesmiddelen en Žirmūnų g. 139A
gezondheidsproducten LT 09120, Vilnius
Afdeling Vigilantie Tel: 8 800 73568
EUROSTATION II Postbus 97 Faksas: 8 800 20131
Victor Hortaplein, 40/40 B-1000 Brussel El. paštas: NepageidaujamaR@vvkt.lt
B-1060 Brussel Madou Interneto svetainė: www.vvkt.lt

[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 Boîte Postale 97
Place Victor Horta, 40/40 B-1000 Bruxelles
B-1060 Bruxelles Madou
s
[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 Postfach 97
Victor Hortaplein, 40/40 B-1000 Brussel
B-1060 Brussel Madou

[For package leaflet]

[Patientenmeldung]
Website: www.fagg-afmps.be
E-Mail: patientinfo@fagg-afmps.be

България Luxembourg/Luxemburg
Изпълнителна агенция по лекарствата
ул. „Дамян Груев“ № 8
1303 София Centre Régional de Pharmacovigilance de Nancy
Teл.: +359 2 8903417 Bâtiment de Biologie Moléculaire et de
уебсайт: www.bda.bg Biopathologie (BBB)
CHRU de Nancy – Hôpitaux de Brabois

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EMA/67830/2013EMA/67830/2013 Page 2/6
 Rue du Morvan
54 511 VANDOEUVRE LES NANCY CEDEX
Tél : (+33) 3 83 65 60 85 / 87
Fax : (+33) 3 83 65 61 33
E-mail : crpv@chru-nancy.fr

ou

Direction de la Santé
Division de la Pharmacie et des Médicaments
Allée Marconi - Villa Louvigny
L-2120 Luxembourg
Tél. : (+352) 2478 5592
Fax : (+352) 2479 5615
E-mail : pharmacovigilance@ms.etat.lu

Link pour le formulaire :

http://www.sante.public.lu/fr/politique-
sante/ministere-sante/direction-sante/div-
pharmacie-medicaments/index.html

Česká republika Magyarország

Státní ústav pro kontrolu léčiv Országos Gyógyszerészeti és
Šrobárova 48 Élelmezés-egészségügyi Intézet
100 41 Praha 10 Postafiók 450
Webové stránky: www.sukl.cz/nahlasit- H-1372 Budapest
nezadouci-ucinek Honlap: www.ogyei.gov.hu

Danmark Malta
Lægemiddelstyrelsen ADR Reporting
Axel Heides Gade 1 Website:
DK-2300 København S www.medicinesauthority.gov.mt/adrportal
Websted: www.meldenbivirkning.dk

Deutschland Nederland
Bundesinstitut für Arzneimittel und Nederlands Bijwerkingen Centrum Lareb
Medizinprodukte Website: www.lareb.nl
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

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EMA/67830/2013EMA/67830/2013 Page 3/6
 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/

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EMA/67830/2013EMA/67830/2013 Page 4/6
España Polska
Sistema Español de Farmacovigilancia de Departament Monitorowania Niepożądanych
Medicamentos de Uso Humano: Działań Produktów Leczniczych Urzędu
www.notificaRAM.es 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.signalement-sante.gouv.fr
Portugal
Sítio da internet:
http://www.infarmed.pt/web/infarmed/submissaor
am
(preferencialmente)
ou através dos seguintes contactos:
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)
E-mail: farmacovigilancia@infarmed.pt

Hrvatska România
Agencija za lijekove i medicinske proizvode Agenţia Naţională a Medicamentului şi a
(HALMED) Dispozitivelor Medicale din România
Internetska stranica: www.halmed.hr ili potražite
HALMED aplikaciju putem Google Play ili Apple Str. Aviator Sănătescu nr. 48, sector 1
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
Website: www.hpra.ie Javna agencija Republike Slovenije za zdravila in
medicinske pripomočke
Sektor za farmakovigilanco
Nacionalni center za farmakovigilanco
Slovenčeva ulica 22
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

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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
e-mail: neziaduce.ucinky@sukl.sk
Tlačivo na hlásenie nežiaduceho účinku je na
webovej stránke www.sukl.sk v časti
Bezpečnosťliekov/Hlásenie o nežiaducich
účinkoch
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
Lääkkeiden haittavaikutusrekisteri
https://www.aifa.gov.it/content/segnalazioni- PL 55
reazioni-avverse 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
Rīga, LV 1003 for MHRA Yellow Card in the Google Play or
Tīmekļa vietne: www.zva.gov.lv Apple App Store

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