Preparation, translation and distribution of Direct Healthcare Professional Communication (DHPC)
The obligation imposed on marketing authorisation holders (MAHs) to prepare and send out direct healthcare professional communications (DHPCs) to health professionals is described in the applicable legislation and guidelines in the area. DHPCs may be distributed based on regulatory procedures such as referrals, variations, PASS, PSUR or RMP, but can also be used in the event of critical supply difficulties or product defects. In principle, the obligation is also applicable to MAHs for authorised products that have not yet been marketed.
The information to be provided in a DHPC is prepared in English in collaboration with the national authorities and/or the European Medicines Agency. A timeline for distribution and a draft distribution list are prepared at the same time.
Regarding DHPCs to be sent out in Denmark, the Danish Medicines Agency must receive a draft Danish translation of the DHPC and a proposed distribution list as well as the final versions of the related proposed English versions from the MAH within the adopted timeline. The material should be sent to Send an email.
For DHPCs whose distribution is to be decided locally by the national authorities, the Danish Medicines Agency must receive the final versions of the proposed English versions from the MAH. The material should be sent to Send an email.
The final DHPC, adjusted at the discretion of the Danish Medicines Agency, will be distributed by the Danish Medicines Agency (unless otherwise agreed) by means of the CPR number and speciality information from the authorisation register to the relevant health professionals' e-Boks.
The information is also distributed by digital post to pharmacies and practising medical specialists by means of the CVR number (business registration number).
If relevant, the information is also sent by email to the to the five main mail boxes of the regions for distribution to the relevant hospital departments, private hospitals and to medicinal products committees, patient organisations and medical societies. Lastly, the information will be made available via a link on the relevant medicine’s page at pro.medicin.dk.
If several MAHs are involved in a procedure in which a DHPC is to be distributed, the Danish Medicines Agency asks the involved MAHs to collaborate on the DHPC to ensure that the recipients receive identical information. If the involved MAHs cannot reach an agreement, the Danish Medicines Agency will appoint a responsible MAH.
In such cases, the MAHs are asked to collaborate and submit one single draft Danish translation of the DHPC and one distribution list. The involved MAHs should also collaborate on the distribution of the letters so that one common DHPC is sent to the recipients on the distribution list.
Questions to the procedure or any doubt about which MAHs are involved should be sent to Send an email.
Note! When MAHs are sending out DHPCs, it is sufficient to add a link to the updated SPC in the DHPC. You do not have to enclose the SPC with the letter.
About the translation
Translations of direct healthcare professional communications (DHPCs) from English into Danish do not have to be word-for-word translations. The Danish text must be as easy and fast to read and understand as the English text is for a native speaker of English. It must of course be the same information that is communicated, but it is often necessary to adjust the language.
Pay attention to:
- Many common English words have a Danish equivalent that is often a rarely used foreign word in Danish. In such cases, you should use a Danish word or expression that is easier to understand. It doesn't matter if the word is completely different from the English word or if you use more words in Danish, as long as the meaning is the same.
- The passive voice is often used in English, but it makes a text difficult to read, so the active voice should be preferred in the Danish text.
- Long sentences should be split into shorter sentences, and remember to use commas and full stops.
- The first translation should be reviewed and perhaps rewritten by at least one or two other persons, because it often gives a better result.
Read more about translations under Guidelines for translating medical product information (in Danish only).
We reserve the right to return DHPC suggestions to marketing authorisation holders (MAHs) if the translation is not of a good quality and has many errors and misunderstandings.