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