Preparation, translation and distribution of Direct Healthcare Professional Communication (DHPC)

11 February 2013, Updated 07 February 2019

The obligation imposed on marketing authorisation holders (MAHs) to prepare and send out Direct Healthcare Professional Communications (DHPCs) to healthcare professionals is described in the Danish Medicines Act and guidelines in the area. 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 by the competent authorities and/or the European Medicines Agency. At the same time, they provide a time frame for circulation and a draft distribution list.

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 time frame. The material should be sent to pharmacovigilance@dkma.dk.

The final Danish DHPC, adjusted according to the Danish Medicines Agency assessment, is to be sent by the MAH (unless otherwise agreed) to doctors on the agreed distribution list within the agreed time frame. A copy of the information/letter must always be sent to the Danish Medicines Agency. It must contain the same material that will be sent to the other recipients on the distribution list.

If several MAHs are involved in a procedure in which a DHPC is to be sent, the Danish Medicines Agency asks the involved MAHs to collaborate on the DHPC to ensure that the recipients receive identical information.

In such cases, the MAHs should only send one draft Danish translation of the DHPC and one distribution list. The involved MAHs should also cooperate 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 pharmacovigilance@dkma.dk.

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.

In order for doctors and other persons to see that the letter contains new safety information (DHPC) the envelopes must be printed (or labelled) with the information in the below file (PDF or JPG formats):

Label til DHPC

Label in PDF format

Label in JPG format

The label/text must be placed at the lower centre of the envelope. The file dimensions are 210 x 15 mm. We recommend that you use white envelopes.

The text has been prepared in collaboration between the Danish Medicines Agency and the Danish Association of the Pharmaceutical Industry.

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. The information must of course be identical, but it is often necessary to adjust the language.

Note:

  • 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 does not 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

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.

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