Current Danish QRD template to be used in connection with the granting of marketing authorisations

11 October 2022

Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as well as for submissions of proposals for Danish summaries of product characteristics in the purely national procedure for applications for new marketing authorisations.

 

Up to now, the Danish Medicines Agency required companies to use the special Danish templates for summaries of product characteristics for human, radioactive and veterinary medicines available on the website www.produktresume.dk. These templates will now be removed from the website.

 

The new requirements for companies to use the current Danish QRD template in force at any time means that the headings of the authorised summaries of product characteristics over time will be different from each other. This is because the headings of the individually authorised Danish summaries of product characteristics will be changed in step with regulatory activities affecting a medicine’s summary of product characteristics and in step with changes to the QRD template.

 

We would also like to stress that we wish to maintain our long-established practice of stating, for example, the D.Sp.No. as well as dispensing group in the summary of product characteristics. These national adjustments of the summary of product characteristics will be made by the Danish Medicines Agency in connection with the granting of a marketing authorisation.

 

For subsequent updates of the Danish summary of product characteristics, e.g. in connection with variation applications, we ask companies to base them on the authorised summary of product characteristics published by the Danish Medicines Agency on www.produktresumé.dk.

The practice is changed as of 1 October 2022.

 

If a company is about to submit Danish product information and has already prepared the summary of product characteristics based on the Danish template used so far, the Danish Medicines Agency will accept submissions based on the old template also after 1 October, but on a transitional basis.

 

Further information and a link to the Danish QRD template can be found on our website.