Marketing authorisations without Danish product information

21 August 2020

The Danish Medicines Agency (DKMA) now gives applicants and marketing authorisation holders the option not to submit a Danish translation of the product information for medicines authorised under MRP/DCP if the medicine is not marketed in Denmark.

The change is effective from 1 September 2020.

Any medicines that are marketed in Denmark are still required to have a Danish summary of product characteristics (SPC) and a Danish package leaflet and labelling. Consequently, everyone living in Denmark will still only receive medicines with a Danish package leaflet included in the package and Danish text on the package.

  1. Marketing authorisations granted under DCP and MRP + RUP for human and veterinary medicines

    A Danish translation of the authorised product information must be submitted to the Danish Medicines Agency on email no later than 7 days after the procedure has been completed. Alternatively, the Danish Medicines Agency should be informed that the applicant does not wish to market the medicines in Denmark.

    If the DKMA receives no translations within the deadline of 7 days, we will assume that the applicant does not wish to market the medicine in Denmark, and the marketing authorisation will be issued without product information in Danish. The authorised SPC in English will be published on the website www.produktresume.dk. Subsequently, any marketing of the medicine will not be allowed in Denmark before the Danish product information has been assessed, see section 3.

  2. Subsequent regulatory procedures for non-marketed medicines (e.g. variations, renewal of marketing authorisations)

    In connection with a regulatory activity for a non-marketed medicine whereby the product information is revised, e.g. a variation application, it will also be possible not to submit a Danish translation of the product information. This applies also to medicines with product information previously in Danish.

    The submission cover letter for the procedure must clearly indicate if the market authorisation holder wants to exercise the option not to submit product information in Danish.

    The DKMA’s authorisation letter will enclose the English SPC with the authorisation.

  3. Marketing of medicines in Denmark at a later stage

    Before the medicine can be marketed in Denmark, updated authorised product information must be available in Danish. A draft Danish version of the SPC, package leaflet and labelling based on the product information authorised by the EU must be submitted. It is the responsibility of the marketing authorisation holder to ensure that all authorised changes are reflected. In this connection, the DKMA requests that the Danish draft be submitted with the English version of the product information that was authorised in a procedure and used to create the Danish draft with an indication of the procedure number e.g. DE/H/XXXX/001-003/047.

    The documents should be sent in one single submission to the DKMA’s Licensing Division.

    The headline of the email should be: ”Danish translation of product information for [name of medicine] – [procedure number]”.

    The draft Danish SPC must be in Word format using the Danish template: http://www.produktresume.dk/AppBuilder/Skabeloner

    The assessment time for product information in Danish could be up to 3 months from receipt of a valid Danish draft of the product information. There is no requirement for the submission of a variation, and no fee is charged for this assessment.

    The medicine cannot be notified to Medicine Prices for marketing before the Danish product information has been assessed.

  4. Parallel import

    A parallel import license is applied for with the intention to market the product immediately after grant of marketing authorisation

    If a parallel import license against a medicine (directly distributed medicine) is applied for and that medicine has no Danish product information because the directly distributed medicine is not marketed in Denmark, the parallel importer is obliged to translate the SPC of the directly distributed medicine and submit it in connection with the application for a parallel import licence. The DKMA requests in this connection that the Danish draft be submitted along with the English SPC used to translate the Danish draft.

    If additional information/warnings are needed for the parallel import medicine, these will be specified in the authorised SPC by the DKMA.

    In addition, a draft package leaflet and labelling in Danish must be submitted with the parallel import application.

    A parallel import license is applied for with the intention not to market the product immediately after grant of marketing authorisation

    As with the granting of marketing authorisations under DCP and MRP/RUP, the parallel importer also has the option to apply for a parallel import licence without Danish product information if the medicine is not marketed in Denmark.

    In this case, it is accepted that no draft versions in Danish of SPC, package leaflet and labelling are submitted.

    The following must be indicated clearly: “DK product information is not desired” in the cover letter under the section ”Yderligere oplysninger om indlægssedlen” (additional details about the package leaflet) in the electronic application form if the applicant wants to exercise the option not to submit product information in Danish.

    Before the medicine can be marketed in Denmark, a submission must be made of the draft Danish versions of SPC, package leaflet and labelling based on the most recent English SPC of the directly distributed medicine published on www.produktresume.dk.

    The DKMA requests in this connection that the Danish draft be submitted along with the English SPC used to translate the Danish draft.

    These documents should be sent in one single submission to the DKMA’s Parallel Import Division.

    The headline of the email should be: ”Danish translation of product information for [name of medicine] – [parallel importer] – [MA number]”.

    The draft Danish SPC must be in Word format using the Danish template: http://www.produktresume.dk/AppBuilder/Skabeloner

    The assessment time for product information in Danish could be up to 3 months from receipt of a valid Danish draft of the product information. There is no requirement for the submission of a variation, and no fee is charged for this assessment.

    The medicine cannot be notified to Medicine Prices for marketing before the Danish product information has been assessed.

    If the English product information of the directly distributed product is revised

    When a new English SPC is authorised for a directly distributed medicine, this SPC will be sent to the parallel importer. The parallel importer must subsequently submit a revised draft of the SPC for the parallel imported product reflecting any changes relevant for the medicine. This draft must be submitted to the Danish Medicines Agency no later than 30 days after the parallel importer has received the new English version of the SPC.

    If there are more than one parallel importer of the same directly distributed medicine, the wording of the respective SPCs must be identical except for product specific details. In this case, the DKMA has nothing against the parallel importers collaborating on the revisions of the SPCs.

    If the parallel importer does not have the medicine on the market, then they can exercise the option not to include product information in Danish.

    If product information in Danish becomes available for the directly distributed medicine

    Should product information in Danish become available for a directly distributed medicine with no previous Danish product information, the DKMA will send an updated Danish SPC to the parallel importer. For any subsequent variations whereby the SPC of the directly distributed medicine is revised, the parallel importer will subsequently receive a revised Danish SPC.

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