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Denmark DMA: Current Danish QRD Template for Granting MA

Denmark's Danish Medicines Agency recently announced on 11th 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.

Quality Review of Documents (QRD) is a specific template used for medicinal product information. There is a distinction between templates for the Centralized procedure, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), and Referrals.

EMA's website provides product information templates in all languages and the annotated version of MRP/DCP QRD templates can be found on HMA's website, while the QRD templates for National procedures are used for MRP, DCP, and referrals.

Danish Medicines Agency made this because the headings of the individually authorized 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.

Since companies must use the current Danish QRD template at any time, the headings of the authorised summaries of product characteristics will vary over time.

Also, the deadline for submitting applications concerning marketing authorisations and clinical trials is December 20th, 2022.

Click this LINK to know more about the Current Danish QRD template that is to be used in connection with the granting of marketing authorisations.


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