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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.
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)
30 Churchill Place Canary Wharf London E14 5EU United Kingdom
An agency of the European UnionTelephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
息 European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.](https://image.slidesharecdn.com/wc5001397521-170215194806/85/Wc500139752-1-1-320.jpg)
![Belgi谷/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 pati谷nten]
Website: www.fagg.be
e-mail: patientinfo@fagg-afmps.be
[French]
Agence f辿d辿rale des m辿dicaments et des produits
de sant辿
Division Vigilance
EUROSTATION II
Place Victor Horta, 40/ 40
B-1060 Bruxelles
[For SmPC]
[Notification par les professionnels de la sant辿]
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]
F旦deralagentur f端r 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
貼irm笛n迭 g. 139A
LT 09120, Vilnius
Tel: 8 800 73568
Faksas: 8 800 20131
El. pa邸tas: NepageidaujamaR@vvkt.lt
Interneto svetain: www.vvkt.lt
仍亞舒亳
亰仗仍仆亳亠仍仆舒 舒亞亠仆亳 仗仂 仍亠从舒于舒舒
仍. 舒仄礌 亠于 8
1303 弌仂亳
Te仍.: +359 2 8903417
亠弍舒亶: www.bda.bg
Luxembourg/Luxemburg
Direction de la Sant辿 Division de la Pharmacie
et des M辿dicaments
Villa Louvigny All辿e Marconi
L-2120 Luxembourg
Site internet:
http://www.ms.public.lu/fr/activites/pharmacie-
medicament/index.html
EMA/67830/2013 Page 2/5](https://image.slidesharecdn.com/wc5001397521-170215194806/85/Wc500139752-1-2-320.jpg)
![esk叩 republika
St叩tn鱈 炭stav pro kontrolu l辿iv
rob叩rova 48
100 41 Praha 10
Webov辿 str叩nky: www.sukl.cz/nahlasit-
nezadouci-ucinek
Magyarorsz叩g
Orsz叩gos Gy坦gyszer辿szeti 辿s
lelmez辿s-eg辿szs辿g端gyi Int辿zet
Postafi坦k 450
H-1372 Budapest
Honlap: www.ogyei.gov.hu
Danmark
SundhedsstyrelsenL脱gemiddelstyrelsen
Axel Heides Gade 1
DK-2300 K淡benhavn S
Websted: www.meldenbivirkning.dk
E-mail: sst@sst.dkdkma@dkma.dk
Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
Deutschland
Bundesinstitut f端r Arzneimittel und
Medizinprodukte
Abt. Pharmakovigilanz
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: http://www.bfarm.de
[For vaccines/biological medicinal products]
Bundesinstitut f端r 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
了了略隆留
慮僚旅虜 粒留僚旅亮 陸留亮略虜僚
竜凌粒竜溜僚 284
GR-15562 律凌了留粒, 慮流僚留
里侶了: + 30 21 32040380/337
陸留両: + 30 21 06549585
凌凌: http://www.eof.gr
sterreich
Bundesamt f端r Sicherheit im Gesundheitswesen
Traisengasse 5
1200 WIEN
STERREICH
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/
EMA/67830/2013 Page 3/5](https://image.slidesharecdn.com/wc5001397521-170215194806/85/Wc500139752-1-3-320.jpg)
![sland
til Lyfjastofnunar, www.lyfjastofnun.is
Slovensk叩 republika
t叩tny 炭stav pre kontrolu lieiv
Sekcia klinick辿ho sk炭邸ania liekov a
farmakovigilancie
Kvetn叩 11
SK-825 08 Bratislava 26
Tel: + 421 2 507 01 206
Fax: + 421 2 507 01 237
internetov叩 str叩nka:
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
L辰辰kealan turvallisuus- ja kehitt辰miskeskus Fimea
L辰辰kkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA
[Swedish]
webbplats: www.fimea.fi
S辰kerhets- och utvecklingscentret f旦r
l辰kemedelsomr奪det Fimea
Biverkningsregistret
PB 55
00034 FIMEA
凌
陸留亮留虜竜旅虜劉 離侶竜溜竜
離凌粒竜溜凌 離粒竜溜留
CY-1475 竜虜溜留
陸留両: + 357 22608649
凌凌: www.moh.gov.cy/phs
Sverige
L辰kemedelsverket
Box 26
751 03 Uppsala
Webbplats: www.lakemedelsverket.se
Latvija
Z勅u valsts a庁ent笛ra
Jersikas iela 15
R朝ga, LV 1003
Tlr.: +371 67078400
Fakss: +371 67078428
T朝mek勅a vietne: www.zva.gov.lv
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
EMA/67830/2013 Page 5/5](https://image.slidesharecdn.com/wc5001397521-170215194806/85/Wc500139752-1-5-320.jpg)
![sland
til Lyfjastofnunar, www.lyfjastofnun.is
Slovensk叩 republika
t叩tny 炭stav pre kontrolu lieiv
Sekcia klinick辿ho sk炭邸ania liekov a
farmakovigilancie
Kvetn叩 11
SK-825 08 Bratislava 26
Tel: + 421 2 507 01 206
Fax: + 421 2 507 01 237
internetov叩 str叩nka:
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
L辰辰kealan turvallisuus- ja kehitt辰miskeskus Fimea
L辰辰kkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA
[Swedish]
webbplats: www.fimea.fi
S辰kerhets- och utvecklingscentret f旦r
l辰kemedelsomr奪det Fimea
Biverkningsregistret
PB 55
00034 FIMEA
凌
陸留亮留虜竜旅虜劉 離侶竜溜竜
離凌粒竜溜凌 離粒竜溜留
CY-1475 竜虜溜留
陸留両: + 357 22608649
凌凌: www.moh.gov.cy/phs
Sverige
L辰kemedelsverket
Box 26
751 03 Uppsala
Webbplats: www.lakemedelsverket.se
Latvija
Z勅u valsts a庁ent笛ra
Jersikas iela 15
R朝ga, LV 1003
Tlr.: +371 67078400
Fakss: +371 67078428
T朝mek勅a vietne: www.zva.gov.lv
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
EMA/67830/2013 Page 5/5](https://image.slidesharecdn.com/wc5001397521-170215194806/85/Wc500139752-1-6-320.jpg)
Wc500139752 (1)
- 1. 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. 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) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European UnionTelephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact 息 European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
- 2. Belgi谷/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 pati谷nten] Website: www.fagg.be e-mail: patientinfo@fagg-afmps.be [French] Agence f辿d辿rale des m辿dicaments et des produits de sant辿 Division Vigilance EUROSTATION II Place Victor Horta, 40/ 40 B-1060 Bruxelles [For SmPC] [Notification par les professionnels de la sant辿] 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] F旦deralagentur f端r 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 貼irm笛n迭 g. 139A LT 09120, Vilnius Tel: 8 800 73568 Faksas: 8 800 20131 El. pa邸tas: NepageidaujamaR@vvkt.lt Interneto svetain: www.vvkt.lt 仍亞舒亳 亰仗仍仆亳亠仍仆舒 舒亞亠仆亳 仗仂 仍亠从舒于舒舒 仍. 舒仄礌 亠于 8 1303 弌仂亳 Te仍.: +359 2 8903417 亠弍舒亶: www.bda.bg Luxembourg/Luxemburg Direction de la Sant辿 Division de la Pharmacie et des M辿dicaments Villa Louvigny All辿e Marconi L-2120 Luxembourg Site internet: http://www.ms.public.lu/fr/activites/pharmacie- medicament/index.html EMA/67830/2013 Page 2/5
- 3. esk叩 republika St叩tn鱈 炭stav pro kontrolu l辿iv rob叩rova 48 100 41 Praha 10 Webov辿 str叩nky: www.sukl.cz/nahlasit- nezadouci-ucinek Magyarorsz叩g Orsz叩gos Gy坦gyszer辿szeti 辿s lelmez辿s-eg辿szs辿g端gyi Int辿zet Postafi坦k 450 H-1372 Budapest Honlap: www.ogyei.gov.hu Danmark SundhedsstyrelsenL脱gemiddelstyrelsen Axel Heides Gade 1 DK-2300 K淡benhavn S Websted: www.meldenbivirkning.dk E-mail: sst@sst.dkdkma@dkma.dk Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal Deutschland Bundesinstitut f端r Arzneimittel und Medizinprodukte Abt. Pharmakovigilanz Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: http://www.bfarm.de [For vaccines/biological medicinal products] Bundesinstitut f端r 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 了了略隆留 慮僚旅虜 粒留僚旅亮 陸留亮略虜僚 竜凌粒竜溜僚 284 GR-15562 律凌了留粒, 慮流僚留 里侶了: + 30 21 32040380/337 陸留両: + 30 21 06549585 凌凌: http://www.eof.gr sterreich Bundesamt f端r Sicherheit im Gesundheitswesen Traisengasse 5 1200 WIEN STERREICH Fax: + 43 (0) 50 555 36207 Website: http://www.basg.gv.at/ EMA/67830/2013 Page 3/5
- 4. Espa単a Sistema Espa単ol de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es Polska Departament Monitorowania Niepo甜danych Dziaa Produkt坦w Leczniczych Urzdu Rejestracji Produkt坦w Leczniczych, Wyrob坦w Medycznych i Produkt坦w Biob坦jczych 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 s辿curit辿 du m辿dicament et des produits de sant辿 (Ansm) et r辿seau des Centres R辿gionaux de Pharmacovigilance Site internet: www.ansm.sante.fr Portugal INFARMED, I.P. Dire巽達o de Gest達o do Risco de Medicamentos Parque da Sa炭de 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 S鱈tio 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 Rom但nia Agen釘ia Na釘ional a Medicamentului i a Dispozitivelor Medicale Str. Aviator Sntescu nr. 48, sector 1 Bucureti 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 klinini center Ljubljana, Interna klinika Center za zastrupitve Zalo邸ka cesta 2 SI-1000 Ljubljana Faks: + 386 (0)1 434 76 46 e-po邸ta: farmakovigilanca@kclj.si EMA/67830/2013 Page 4/5
- 5. sland til Lyfjastofnunar, www.lyfjastofnun.is Slovensk叩 republika t叩tny 炭stav pre kontrolu lieiv Sekcia klinick辿ho sk炭邸ania liekov a farmakovigilancie Kvetn叩 11 SK-825 08 Bratislava 26 Tel: + 421 2 507 01 206 Fax: + 421 2 507 01 237 internetov叩 str叩nka: 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 L辰辰kealan turvallisuus- ja kehitt辰miskeskus Fimea L辰辰kkeiden haittavaikutusrekisteri PL 55 00034 FIMEA [Swedish] webbplats: www.fimea.fi S辰kerhets- och utvecklingscentret f旦r l辰kemedelsomr奪det Fimea Biverkningsregistret PB 55 00034 FIMEA 凌 陸留亮留虜竜旅虜劉 離侶竜溜竜 離凌粒竜溜凌 離粒竜溜留 CY-1475 竜虜溜留 陸留両: + 357 22608649 凌凌: www.moh.gov.cy/phs Sverige L辰kemedelsverket Box 26 751 03 Uppsala Webbplats: www.lakemedelsverket.se Latvija Z勅u valsts a庁ent笛ra Jersikas iela 15 R朝ga, LV 1003 Tlr.: +371 67078400 Fakss: +371 67078428 T朝mek勅a vietne: www.zva.gov.lv United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard EMA/67830/2013 Page 5/5
- 6. sland til Lyfjastofnunar, www.lyfjastofnun.is Slovensk叩 republika t叩tny 炭stav pre kontrolu lieiv Sekcia klinick辿ho sk炭邸ania liekov a farmakovigilancie Kvetn叩 11 SK-825 08 Bratislava 26 Tel: + 421 2 507 01 206 Fax: + 421 2 507 01 237 internetov叩 str叩nka: 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 L辰辰kealan turvallisuus- ja kehitt辰miskeskus Fimea L辰辰kkeiden haittavaikutusrekisteri PL 55 00034 FIMEA [Swedish] webbplats: www.fimea.fi S辰kerhets- och utvecklingscentret f旦r l辰kemedelsomr奪det Fimea Biverkningsregistret PB 55 00034 FIMEA 凌 陸留亮留虜竜旅虜劉 離侶竜溜竜 離凌粒竜溜凌 離粒竜溜留 CY-1475 竜虜溜留 陸留両: + 357 22608649 凌凌: www.moh.gov.cy/phs Sverige L辰kemedelsverket Box 26 751 03 Uppsala Webbplats: www.lakemedelsverket.se Latvija Z勅u valsts a庁ent笛ra Jersikas iela 15 R朝ga, LV 1003 Tlr.: +371 67078400 Fakss: +371 67078428 T朝mek勅a vietne: www.zva.gov.lv United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard EMA/67830/2013 Page 5/5