Adapted QRD templates and guideline for Danish product information for veterinary medicines

Updated 17 February 2021

Here you can find the Danish templates which your company must use to draw up the summary of product characteristics, package leaflet and labelling for veterinary medicines.

Two templates are available - one for the summary of product characteristics and one for the package leaflet and labelling. A Danish guideline on the two templates is also available. The guideline provides standard texts and help texts for the individual sections.

Marketing authorisation holders must use the templates to draw up product information in Danish for veterinary medicines approved according to the EU procedures (MRP or DCP) or according to national procedure.

Templates

Template for the summary of product characteristics for veterinary medicines (in Danish only)

Template for the package leaflet and labelling for veterinary medicines (in Danish only)

Guideline

The guideline was updated 29 October 2020:

Various links were updated, various linguistic changes have been made amongst others in the SmPC point 4.6 and additional options in SmPC point 4.7 and correspondingly in the PIL. The labelling and PIL were updated in point 10 and point 11 respectively according to Q/A at the DKMA website.

Guideline for the summary of product characteristics, package leaflet and labelling for veterinary medicines (in Danish only)

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