Direct Healthcare Professional Communications: What They Are and When Used

Direct healthcare professional communications (DHPC)

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 direct healthcare professional communications on this website. Human Medicines

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;
• quality problems with a medicine;
• a medicine supply shortage related to a quality, safety or efficacy issue. In cases where a shortage is not linked to a quality, safety or efficacy issue, marketing authorisation holders can send medicine shortage communications (MSCs) instead of DHCPs. For example, this applies to withdrawals due to commercial decisions or to unexpected increases in demand for certain medicines.

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:

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

Adopted Reference Number: EMA/118465/2012 Legal effective date:

13/10/2017

English (EN) (188.52 KB - PDF)

First published:

24/01/2013

Last updated:

12/10/2017

View For more information, see:

• Pharmacovigilance: post-authorisation
• Medicine shortage communications (MSC)

Direct healthcare professional communications published by EMA

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

National registers of direct health professional communications

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/dhpcs-directhealtcareprofessionalcommunications (FR)

https://www.fagg.be/nl/MENSELIJKgebruik/geneesmiddelen/geneesmiddelen/geneesmiddelenbewaking/dhpcs-directhealtcareprofessional_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

| https://sukl.gov.cz/prumysl/leciva/farmakovigilance/informace-k-bezpecnosti-leciv/informacni-dopisy-zdravotnickym-pracovnikum/ |
| 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-BriefeInformationsbriefe/functions/RIrhbFiltersuche_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/en/sicurezza-dei-farmaci |
| Latvia

| https://www.zva.gov.lv/lv/industrijai/zalu-registracijas-apliecibu-ipasnieki/farmakovigilance/vestules-veselibas-aprupes-specialistiem |
| Lithuania

| https://www.vvkt.lt/index.php?3139344720 |
| Luxembourg

| https://santesecu.public.lu/fr/espace-professionnel/domaines/pharmacies-et-medicaments/pharmacovigilance/gestion-riques/dhcp.html |
| Malta

| http://www.medicinesauthority.gov.mt/dhpc |
| Netherlands

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

| https://www.gov.pl/web/urpl/komunikaty-dot-produktow-leczniczych |
| Portugal

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

| https://www.lyfjastofnun.is/lyfjagat/bref-til-heilbrigdisstarfsmanna-dhpc/ |
| Liechtenstein

| See Austria |
| Norway

| https://www.dmp.no/bivirkninger-og-sikkerhet/tiltak-for-a-forebygge-bivirkninger/sikkerhetsinformasjon-til-helsepersonell-og-pasient/kjere-helsepersonell-brev |

Related content

• Medicine shortage communications (MSC)
• Good pharmacovigilance practices (GVP)
• Medicine shortages and availability issues

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