Marketing authorisations without Danish product information

21 August 2020, Updated 11 October 2022

Updated 30 September 2022 Updated with a new separate section 2 for veterinary medicines; veterinary medicines were previously comprised by section 1. The update also reflects the new practice of 1 October 2022 to use a Danish QRD template instead of the special Danish template for summaries of product characteristics.


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

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. This means that everyone living in Denmark receive only medicines with a Danish package leaflet in the package and Danish text on the package.

  1. Marketing authorisations granted under DCP, MRP and RUP for human 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 has no intention to market the medicine in Denmark.

If the Danish Medicines Agency 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 4.

  1. Marketing authorisations granted under DCP, MRP and SRP for veterinary medicines

A Danish translation of the authorised product information must be submitted to the Danish Medicines Agency on email no later than 6 months after the procedure has been completed. Alternatively, the Danish Medicines Agency should be informed that the applicant has no intention to market the medicine in Denmark. Despite this deadline, we recommend that translations be submitted as soon as possible after the procedure close date.

If we are informed that there is no intention to market the medicine in Denmark, 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 4.

  1. 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 Danish Medicines Agency’s authorisation letter will enclose the English SPC with the authorisation.

  1. 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 Danish Medicines Agency 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 Danish Medicines Agency’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 should be in Word format and must use the Danish QRD templates for human medicines and veterinary medicines as relevant. 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.

  1. Parallel import

A parallel import license is applied for with the intention to market the product immediately after granting of the MA

If a parallel import license involving 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 Danish Medicines Agency 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 Danish Medicines Agency.

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 granting of the MA

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: “No intention to place product on the market immediately after the granting of the MA, and therefore no Danish product information is enclosed”. The cover letter or the electronic PI application must enclose draft labelling and package leaflet named “No intention to place product on the market immediately after the granting of the MA” in case 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 Danish Medicines Agency 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 Danish Medicines Agency’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 should be in Word format and must use the Danish QRD templates for human medicines and veterinary medicines as relevant.

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 to the medicine. This draft must be submitted to the Danish Medicines Agency no later than 30 days after the parallel importer 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 Danish Medicines Agency does not mind parallel importers working together on the revisions of the SPCs.

If the parallel importer has not placed the medicine on the market, 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 Danish Medicines Agency 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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