DHPCs serve to inform healthcare professionals of, for example:

  • a suspension, withdrawal or revocation of a marketing authorisation for safety reasons;
  • an important change, for example a restriction of indication, a new contraindication or a change in the recommended dose;
  • a medicine supply shortage;
  • quality problems with a medicine.

DHPCs agreed at EU level include a communication plan specifying the intended recipients and the dissemination date.

National competent authorities may adapt the text agreed at EU level to their specific situation, so the final letter a healthcare professional receives may differ slightly from the version published on the EMA website.

The European Medicines Agency (EMA) publishes DHPCs agreed at European Union (EU) level and links to national registers of DHPCs, as of February 2020.

For more information, regulatory guidance and templates, see:

Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)

DHPCs published by EMA

For a list of DHPCs agreed at EU level and published by EMA, see our Medicine search: DHPCs.

National registers

National competent authorities publish DHPCs in their official languages.

Please note that the information in these national registers may not be available in English.

EU Member StateMedicine register
Austrian flag

 Austria

https://www.basg.gv.at/gesundheitsberufe/sicherheitsinformationen-dhpc
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 Belgium

https://www.afmps.be/fr/humain/medicaments/medicaments/pharmacovigilance/dhpc_s_-_direct_healtcare_professional_communications (FR)

https://www.fagg.be/nl/MENSELIJK_gebruik/geneesmiddelen/geneesmiddelen/geneesmiddelenbewaking/dhpc_s_-_direct_healtcare_professional_communications (NL)

Bulgarian flag

 Bulgaria

https://www.bda.bg/bg/лекарствена-безопасност-съобщения/преки-съобщения-до-медицинските-специалисти

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 Croatia

http://www.halmed.hr/Farmakovigilancija/Pisma-zdravstvenim-radnicima/

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 Cyprus

No online register available yet
czechrepublic.gif

 Czechia

http://www.sukl.cz/leciva/informacni-dopisy-lekarum

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 Denmark

https://laegemiddelstyrelsen.dk/da/bivirkninger/direkte-sikkerhedsinformation/udsendte-meddelelser/

Estonian flag

 Estonia

https://www.ravimiamet.ee/ohutusalased-teabekirjad

finland.gif

 Finland

https://www.fimea.fi/ajankohtaista/laaketurvatiedotteet/myyntiluvanhaltijoiden_tiedotteet

france.gif

 France

https://ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante

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 Germany

https://www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/Rote-Hand-Briefe_Informationsbriefe/_functions/RI_rhb_Filtersuche_Formular.html

https://www.pei.de/DE/newsroom/veroffentlichungen-arzneimittel/sicherheitsinformationen-human/sicherheitsinformationen-human-node.html;jsessionid=E9871C8D5D9AE8DB94ACE2D8256E95B0.2_cid319 (biologicals / vaccines)

greece.gif

 Greece

https://www.eof.gr/web/guest/announcements
hungary.gif

 Hungary

https://www.ogyei.gov.hu/dhpc_levelek/

ireland.gif

 Ireland

https://www.hpra.ie/homepage/medicines/safety-notices?type=4&orderby=DATE_NEWEST
italy.gif

 Italy

https://www.aifa.gov.it/ricerca?q=nota+informativa+importante
latvia.gif

 Latvia

https://www.zva.gov.lv/lv/veselibas-aprupes-specialistiem-un-iestadem/zales/farmakovigilance/vestules-veselibas-aprupes-specialistiem
lithuania.gif

 Lithuania

https://www.vvkt.lt/index.php?3139344720
luxembourg.gif

 Luxembourg

https://sante.public.lu/fr/espace-professionnel/domaines/pharmacies-et-medicaments/pharmacovigilance/dhcp.html
malta.gif

 Malta

http://www.medicinesauthority.gov.mt/dhpc
netherlands.gif

 Netherlands

https://www.cbg-meb.nl/onderwerpen/medicijninformatie-nieuws-over-veiligheid-van-medicijnen

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 Poland

http://www.urpl.gov.pl/pl/produkty-lecznicze/komunikaty-bezpiecze%C5%84stwa-0
portugal.gif

 Portugal

https://extranet.infarmed.pt/INFOMED-fo/pesquisa-avancada.xhtml
romania.gif

 Romania

https://www.anm.ro/medicamente-de-uz-uman/farmacovigilenta/comunicari-directe-catre-profesionistii-din-domeniul-sanatatii/
slovakia.gif

 Slovakia

https://www.sukl.sk/hlavna-stranka/slovenska-verzia/bezpecnost-liekov/oznamy-drzitelov-dhpc?page_id=2155
slovenia.gif

 Slovenia

https://www.jazmp.si/humana-zdravila/farmakovigilanca/obvestila-za-zdravstvene-delavce/neposredna-obvestila-za-zdravstvene-delavce/
spain.gif

 Spain

https://www.aemps.gob.es/medicamentos-de-uso-humano/farmacovigilancia-de-medicamentos-de-uso-humano/cartas_segprofsani/
sweden.gif

 Sweden

https://lakemedelsverket.se/dhpc
EEA Member State
iceland.jpg

 Iceland

https://www.lyfjastofnun.is/lyfjagat/bref-til-heilbrigdisstarfsmanna-dhpc/
liechtenstein.jpg

 Liechtenstein

See Austria
norway.jpg

 Norway

https://legemiddelverket.no/bivirkninger-og-sikkerhet/kjere-helsepersonell-brev-sikkerhetsinformasjon-for-helsepersonell

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