18 June 2018

EMA/67830/2013, Version 161

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.

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)

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact An agency of the European Union

© European Medicines Agency, 2019. 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 Faksas: 8 800 20131
Victor Hortaplein, 40/ 40 El. paštas: NepageidaujamaR@vvkt.lt
B-1060 Brussel 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
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
ул. „Дамян Груев“ № 8 et des Médicaments
1303 София Villa Louvigny – Allée Marconi
Teл.: +359 2 8903417 L-2120 Luxembourg
уебсайт: www.bda.bg Site internet:
http://www.ms.public.lu/fr/activites/pharmacie-
medicament/index.html

EMA/67830/2013 Page 2/5

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
E-mail: dkma@dkma.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

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/

EMA/67830/2013 Page 3/5

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 Portugal
Agence nationale de sécurité du médicament et INFARMED, I.P.
des produits de santé (Ansm) Direção de Gestão do Risco de Medicamentos
et réseau des Centres Régionaux de Parque da Saúde de Lisboa, Av. Brasil 53
Pharmacovigilance 1749-004 Lisboa
Site internet: www.ansm.sante.fr 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/submissaor
am
E-mail: farmacovigilancia@infarmed.pt

Hrvatska România
Agencija za lijekove i medicinske proizvode Agenţia Naţională a Medicamentului şi a
(HALMED) Dispozitivelor Medicale
Internetska stranica: www.halmed.hr ili potražite Str. Aviator Sănătescu nr. 48, sector 1
HALMED aplikaciju putem Google Play ili Apple Bucureşti 011478- RO
App Store trgovine 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
IRL - Dublin 2 medicinske 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

EMA/67830/2013 Page 4/5

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- Lääkkeiden haittavaikutusrekisteri
segnalare-una-sospetta-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
Rīga, LV 1003 for MHRA Yellow Card in the Google Play or
Tīmekļa vietne: www.zva.gov.lv Apple App Store

EMA/67830/2013 Page 5/5