Guideline on the use of QRD templates for summaries of product characteristics, package leaflets and labelling of human medicinal products

Updated according to new practice of 1 October 2022 to use the current Danish QRD template instead of the special Danish template for summaries of product characteristics for submission of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as well as for submission of proposals for Danish summaries of product characteristics in the purely national procedure for applications for new marketing authorisations.

QRD (Quality Review of Documents) – the templates are updated regularly.

The QRD templates are used to prepare proposals for summary of product characteristics, package leaflet and labelling of human medicines submitted under the centralised procedure and via the purely national procedure, the mutual recognition procedure or the decentralised procedure.

In order for the summary of product characteristics and package leaflet to follow the same guidelines, regardless of authorisation procedure, the Danish Medicines Agency has decided that the QRD templates must be used when the companies submit proposals for the summary of product characteristics, package leaflet and labelling in the following cases:

• Application for marketing authorisation, both under the national procedure and via the central or decentralised procedure as well as the mutual recognition procedure
• Update/reprint of package leaflets and summaries of product characteristics of already authorised products
• Application for renewal of marketing authorisations for already authorised medicines

Please find a link to the QRD Human Product Information Templates in the box to the right.

Link to the current guidelines for preparing the Danish summaries of product characteristics (in Danish only). The current guidelines for preparing Danish summaries of product characteristics have not been updated yet but should be followed to the extent possible in respect of standard texts not comprised by the QRD template.

As of 1 October 2022, the Danish Medicines Agency has introduced a new practice to use the Danish version of the QRD template when submitting summaries of product characteristics to the Danish Medicines Agency in connection with the granting of a marketing authorisation. Up to now, the Danish Medicines Agency required companies to use a special Danish template for the summaries of product characteristics.

The implication of the new practice is 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.produktresume.dk.