​The preparation of DHPCs involves cooperation between the marketing authorisation holder (MAH) and the Norwegian Medicines 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 (bivirkninger@legemiddelverket.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 no longer necessary to send DHPCs to the Regional Pharmacovigilance Centers (RELIS).

Other communication

Information letters regarding drug shortage should be sent to legemiddelmangel@legemiddelverket.no

Information letters regarding quality defect/technical issues should be sent to rapidalert@legemiddelverket.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.

Labeling

DHPCs should be labeled with NOMAs logo for safety information.

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. In the section regarding reporting of adverse reactions, the following text should be included:

«▼Dette legemidlet er underlagt særlig overvåking for å oppdage ny sikkerhetsinformasjon så raskt som mulig». 

Dissemination

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 manus.fk@lmi.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 Medicines Agency" in the subject field. The DHPC is attached to the e-mail in pdf format.

DHPCs to other groups of health professionals must be sent by mail.

Publication on NOMAs website

NOMA publishes all DHPCs in an archive. The final version of the letter should be sent to NOMA prior to distribution for publication.

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).

Publisert: 18.01.2019

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