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:

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
 Austriahttps://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/

 CyprusNo 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.fimea.fi/ajankohtaista/laaketurvatiedotteet/myyntiluvanhaltijoiden_tiedotteet

 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

 GreeceNo online register available yet
 Hungary

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

 Irelandhttps://www.hpra.ie/homepage/medicines/safety-notices?type=4&orderby=DATE_NEWEST
 Italyhttps://www.aifa.gov.it/ricerca?q=nota+informativa+importante
 Latviahttps://www.zva.gov.lv/lv/veselibas-aprupes-specialistiem-un-iestadem/zales/farmakovigilance/vestules-veselibas-aprupes-specialistiem
 Lithuaniahttps://www.vvkt.lt/index.php?3139344720
 LuxembourgNo online register available yet
 Maltahttp://www.medicinesauthority.gov.mt/dhpc
 Netherlands

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

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

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