Guidelines on the use of QRD templates for summary of product characteristics, package leaflet and labelling of veterinary medicines

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

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.

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 indicating, for example, the D.Sp.No., dispensing group and representative of the marketing authorisation holder 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.

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

The box to the right also provides a link to the current guidelines for preparing the Danish summary of product characteristics, package leaflet and labelling (in Danish only). The current guidelines have not been updated yet but should be followed to the extent possible in respect of standard texts not comprised by the QRD template.