Preparing, translating and distributing safety information (DHPC)

The marketing authorisation holder of a medicine (the pharmaceutical company or abbreviated as MAH) is required to prepare direct healthcare professional communications (DHPCs) when the situation requires. These requirements are described in the legislation and guideline applicable in the area. The decision to issue DHPC letters is often based on new safety information or changes to recommended clinical practice arising from regulatory procedures such as referrals, variations, PASSs, PSURs, signals or RMPs. DHPCs may also be issued in the event of supply difficulties or product defects and withdrawals. The requirement extends to all MAHs and applies to all authorised products, whether or not the product is marketed at the time when the DHPC is issued.

The information to be provided in a DHPC is prepared in English by the competent authorities and/or the European Medicines Agency, along with a time frame for translation and dissemination and a proposed DHPC distribution list.

DHPCs disseminated in Denmark

When a DHPC is disseminated in Denmark, the Danish Medicines Agency must receive a draft Danish translation of the DHPC letter along with the final English version of the document from the MAH. In the process of translating or preparing the DHPC letter, no logo must be inserted at the top of the document, however, a small logo as part of the signature at the bottom of the document is accepted.  When product information is updated there is no need to enclose it with the DHPC. It is sufficient to link to the product information in the DHPC letter.

MAHs are also required to submit a proposed list of recipients adjusted to the Danish/national context. The proposed list of recipients should at least include medical specialties and any other healthcare professional groups considered relevant. Specific lists with contact information are not required. All documents must be submitted by the MAH in accordance with the agreed time frame. The documents must be sent to the Danish Medicines Agency by email.

MAHs are furthermore requested to provide their CVR number (business registration number) for it to be included on the list of recipients. If there is more than one MAH, the CVR number for each company must be provided.

About the translation

The translation of DHPC letters from English to Danish should not be a word-for-word translation. While the meaning provided must naturally remain the same, linguistic adjustments are often necessary to ensure the information is easily understandable in Danish.

Here are some points to pay attention to:

• For many common English words, there is a word in Danish that looks similar but is actually a rarely used loanword. Such words should be replaced by a word or expression in Danish that is easier to understand. It doesn’t matter if the word looks different from the English word, or if you use more words in Danish, as long as the meaning remains the same.
• You may often come across English sentences in the passive voice. You should change this to the active voice in Danish to make it easier to read.
• Long sentences should be split into shorter ones, inserting commas and full stops.
• The first translation should be reviewed and preferably reworked by an additional one or two reviewers; this will often reduce the total translation time and improve the result.
• Detailed guidelines on Danish translations are available in Guidelines for translation of product information.

The Danish Medicines Agency may, at its discretion, return a proposed DHPC to the MAH if the quality of the translation is poor due to many errors, omissions and misinterpretations.

Dissemination of DHPCs

The final DHPC, after quality assurance by the Danish Medicines Agency, is disseminated by the Danish Medicines Agency via e-Boks to relevant healthcare professionals. CPR (civil registration ) numbers and medical specialty information from the register of licenced healthcare professionals are used to identify relevant healthcare professionals via their healthcare authorisation(s). The register enables sorting by specialty and authorised professions such as dentist or midwife.

In addition, the DHPC letter is disseminated via digital post to pharmacies and, if relevant, practising medical specialists by means of CVR (business registration) numbers.

The information is also sent by email to the five regional mailboxes for dissemination to relevant hospital departments and, if relevant, to private hospitals, medicinal product committees, medical societies and patient organisations. Finally, the information is published on the website of the Danish Medicines Agency and at pro.medicin.dk where the DHPC may be accessed via a link placed at the top of the medicine’s page for a period of six months after dissemination.

The dissemination of DHPCs by the Danish Medicines Agency is subject to a small fee paid by the companies. This amount is included in the annual fee for all MAHs, so all companies are charged the same fee. 

The dissemination of DHPCs on behalf of several MAHs

If there are several MAHs involved in a procedure to issue a DHPC, the Danish Medicines Agency requests the involved MAHs to work together and observe the following:

• A single consistent DHPC should be prepared for all MAHs.
• The DHPC letter must cover all products registered in Denmark including non-marketed products. In case of uncertainty about the MAHs holding marketing authorisations for products containing the substance in question, reference is made to the list of authorised medicinal products in Denmark.
• The preparation of the DHPC should generally be coordinated by the MAH of the originator product. If the DHPC concerns several different active substances, the MAH of the originator product with the largest market share in Denmark should assume the coordinating role. In case only generic versions are registered on the Danish market, the MAH of the generic version with the largest Danish market share should assume the coordinating role. You can search for data on the consumption of products containing the concerned substance broken down by MAHs at medstat.dk (Danish Health Data Authority).
• Parallel importers are generally not required to participate in the issue of DHPCs.
• It is the coordinating MAH that acts as point of contact for the Danish Medicines Agency on behalf of all MAHs involved. The coordinating MAH is expected to collaborate with the other involved MAHs on the preparation of the Danish translation of the DHPC. This includes forwarding the DHPC to the Danish Medicines Agency and obtaining CVR numbers of the involved MAHs should they wish to receive the DHPC when it is disseminated via e-Boks.
• The prepared DHPC must list all MAHs with contact information and product name, unless otherwise agreed with the Danish Medicines Agency. The contact information provided in the DHPC should include the following details: MAH/local representative, name, telephone number and email address of local contact person. If there are many MAHs, we advise you to provide the contact information in table form.

If an agreement cannot be reached between the involved MAHs, the Danish Medicines Agency appoints a responsible MAH.

If you have any questions to the procedure, please contact us by email.