Direct healthcare professional communications

A marketing authorisation holder may send a direct healthcare professional communication (DHPC) to healthcare professionals to inform them of important new safety information about a medicine and any actions they should take.  The European Medicines Agency (EMA) publishes DHPCs agreed at European Union (EU) level and links to national registers of DHPCs, as of February 2020.

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.

For more information, regulatory guidance and templates, see:

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 State Medicine register
 Austria https://www.basg.gv.at/gesundheitsberufe/sicherheitsinformationen-dhpc
 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)

 Bulgaria

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

 Croatia

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

 Cyprus No online register available yet
 Czechia

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

 Denmark

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

 Estonia

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

 Finland

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

 France

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

 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 https://www.eof.gr/web/guest/announcements
 Hungary

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

 Ireland https://www.hpra.ie/homepage/medicines/safety-notices?type=4&orderby=DATE_NEWEST
 Italy https://www.aifa.gov.it/ricerca?q=nota+informativa+importante
 Latvia https://www.zva.gov.lv/lv/veselibas-aprupes-specialistiem-un-iestadem/zales/farmakovigilance/vestules-veselibas-aprupes-specialistiem
 Lithuania https://www.vvkt.lt/index.php?3139344720
 Luxembourg No online register available yet
 Malta http://www.medicinesauthority.gov.mt/dhpc
 Netherlands

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

 Poland http://www.urpl.gov.pl/pl/produkty-lecznicze/komunikaty-bezpiecze%C5%84stwa-0
 Portugal http://app7.infarmed.pt/infomed/pesquisa.php
 Romania https://www.anm.ro/medicamente-de-uz-uman/farmacovigilenta/comunicari-directe-catre-profesionistii-din-domeniul-sanatatii/
 Slovakia https://www.sukl.sk/hlavna-stranka/slovenska-verzia/bezpecnost-liekov/oznamy-drzitelov-dhpc?page_id=2155
 Slovenia https://www.jazmp.si/humana-zdravila/farmakovigilanca/obvestila-za-zdravstvene-delavce/neposredna-obvestila-za-zdravstvene-delavce/
 Spain https://www.aemps.gob.es/medicamentos-de-uso-humano/farmacovigilancia-de-medicamentos-de-uso-humano/cartas_segprofsani/
 Sweden https://lakemedelsverket.se/dhpc
EEA Member State
Iceland flag Iceland https://www.lyfjastofnun.is/lyfjagat/bref-til-heilbrigdisstarfsmanna-dhpc/
Liechtenstein flag Liechtenstein See Austria
Norway flag Norway https://legemiddelverket.no/bivirkninger-og-sikkerhet/kjere-helsepersonell-brev-sikkerhetsinformasjon-for-helsepersonell

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