Guidance for submission of Norwegian translations of direct healthcare professional communication (DHPC)
Published:
Changes
Direct healthcare professional communication (DHPC) is communication regarding important safety information delivered directly to individual healthcare professionals by a marketing authorisation holder.
Page contents
The preparation of DHPCs involves cooperation between the marketing authorisation holder (MAH) and the Norwegian Medical Products Agency (NOMA). Agreement between these two parties should be reached before a DHPC is issued by the marketing authorisation holder. The agreement will cover both the content of the DHPC and the communication plan including the intended recipients, the timetable and the channels for disseminating the DHPC (See more information in Good Vigilance Practices - module XV).
Where there are several marketing authorisation holders of the same active substance and/or a class of products for which a DHPC is to be issued, a single consistent message should be delivered to healthcare professionals.
Submission of Norwegian translations to NOMA
The following documents should be sent to NOMA by email to bivirkninger@dmp.no:
- The English version of the DHPC
- The Norwegian translation in clear and concise language adjusted to the target group
- Suggestions for recipients of the DHPC
It is not necessary to send DHPCs to the Regional Pharmacovigilance Centers (RELIS).
Other communication
Information letters regarding drug shortage should be sent to legemiddelmangel@dmp.no
Information letters regarding quality defect/technical issues should be sent to rapidalert@dmp.no
Comments from NOMA
NOMA will review the DHPCs and provide comments to content and target groups, but does not issue an approval per se.
Standard labeling
DHPCs should be labeled with NOMAs logo for safety information.
Standard text
In the DHPC-letter, there should be a standard sentence calling for reporting suspected adverse reactions through the national reporting system.
Standard text for reporting adverse reactions (for medicinal products without black triangle)
Oppfordring om å melde mistenkte bivirkninger
Melding av mistenkte bivirkninger etter godkjenning av legemidlet er viktig. Det gjør det mulig å overvåke forholdet mellom nytte og risiko for legemidlet kontinuerlig.
Helsepersonell oppfordres til å melde nye, uventede og alvorlige mistenkte bivirkninger på elektronisk meldeskjema: www.dmp.no/meldeskjema
Standard text for reporting adverse reactions (for medicinal products without black triangle)
Oppfordring om å melde mistenkte bivirkninger
▼ Dette legemidlet er underlagt særlig overvåking for å oppdage ny sikkerhetsinformasjon så raskt som mulig.
Helsepersonell oppfordres til å melde enhver mistenkt bivirkning. Dette gjøres via meldeskjema som finnes på nettsiden til Direktoratet for medisinske produkter: www.dmp.no/meldeskjema
Black triangle▼
DHPCs regarding a medicinal product under additional monitoring must be labeled with the black triangle ▼. The triangle should be placed in front of the product name (▼product name) in the start of the letter, as applicable.
Dissemination
Pharmacies
DHPCs can be disseminated to community and hospital pharmacies by e-mail. A list of the pharmacies e-mail addresses can be retrieved from Felleskatalogen. To receive the lists, send an e-mail to fkmanus@felleskatalogen.no with the subject field "E-mail pharmacy for dissemination of DHPC".
The e-mail disseminated to the pharmacies should contain the text "Safety information in collaboration with the Norwegian Medical Products Agency" in the subject field. The DHPC is attached to the e-mail in pdf format.
General practicioners
DHPC letters to general practitioners are distributed exclusively via electronic channels, this is handled by the Norwegian Medical Products Agency (see section Publication).
Pharmaceutical companies do not need to distribute the letter to GPs/GPs on paper.
Other groups of health personnell
DHPCs to other groups of health professionals must be sent by mail.
Publication
NOMA publishes all DHPCs in an archive. The final version of the letter should be sent to NOMA prior to distribution for publication.
NoMA will also notify prescribing physicians of a new DHPC-letter through the patient journal (EPJ)
The Norwegian Pharmaceutical Compendium (Felleskatalogen) will publish the DHPCs intergrated into safety alerts from NOMA. Felleskatalogen will collect the DHPCs from NOMAs website (the MAH does not have to send the letter to Felleskatalogen).