Preparing, translating and distributing safety information (DHPC)
The marketing authorisation holder of a medicine (MAH) is required to prepare direct healthcare professional communications (DHPCs) when the situation requires. These requirements are described in the current legislation and guideline of the area. The decision to issue a DHPC is often based on new safety information or a change in the recommended clinical practice arising from regulatory procedures such as referrals, variations, PASSs, PSURs, signals or RMPs. DHPCs can 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, regardless of whether the product is marketed at the time when the DHPC is issued.
The information to be provided in a DHPC is prepared in English in collaboration with the competent authorities and/or the European Medicines Agency (EMA) along with a timetable for translation and dissemination as well as a draft list of recipients.
DHPCs disseminated in Denmark
When a DHPC is disseminated in Denmark, the Danish Medicines Agency must receive a draft Danish translation of the DHPC along with the final English version of the document from the MAH. In connection with the translation or preparation of the DHPC, 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. Updated product information, if relevant, should not be attached to the DHPC; it is sufficient to provide a link in the DHPC.
MAHs are also required to submit a proposed list of recipients adjusted to the Danish context. The proposed list of recipients should at least include medical specialties and any other healthcare professional groups of relevance. Specific lists with contact information are not required. All documents must be submitted by the MAH in accordance with the agreed timetable. The documents must be sent to us by email.
MAHs are furthermore requested to provide their CVR number (central business registration number) to be included on the list of recipients. If there are more than one MAH, provide the CVR number for each MAH.
About the translation
The translation of the DHPC from English to Danish should not be a word-for-word translation. The Danish text should be just as easy to read for a Dane as the English version is for a native English speaker. The meaning provided must obviously remain the same, but linguistic adjustments are often necessary.
For instance, please remember this:
- Many common English words have a Danish word that looks or sounds similar but actually is a foreign word that is not used very often. Instead, please use 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 possibly rewritten by at least one or two other persons, as this will often reduce the overall time spent on translation 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, adjusted at the discretion of the Danish Medicines Agency, will be disseminated by the Danish Medicines Agency unless otherwise agreed. DHPCs are sent via e-Boks to the relevant healthcare professionals. These are identified using CPR (civil registration) numbers and specialisation data from the Online register (of registered health professionals).
In addition, the DHPC is disseminated via Digital Post to pharmacies and practising specialists using CVR numbers.
If considered relevant, the information is also sent by email to the five regional mailboxes for dissemination to relevant hospital departments, private hospitals, medicinal product committees and medical societies. Finally, the information will be published on the website of the Danish Medicines Agency and at pro.medicin.dk by linking to the DHPC from the web page of the concerned medicine.
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, which means that the fee is the same for all companies.
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 observe the following:
- A single consistent DHPC should be prepared for all MAHs.
- The DHPC must cover all products registered in Denmark including non-marketed products. In case of uncertainty about which MAHs hold a marketing authorisation for products containing the concerned substance, we advise you to look up the list of authorised medicinal products.
- 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 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.
- 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.