Electronic leaflets for veterinary medicinal products have too small font size

For industry

The Danish Medicines Agency monitors the readability of the electronic leaflets uploaded to DKMAnet. This is done by taking samples from the marked. The leaflets are printed out and the readability is assessed. It is important that you are able to find information about your medicine in the Package Leaflet at any time, even if the package leaflet from your medicine pack is lost.

At the moment, we sample leaflets for veterinary medicinal products. In these samples we have found that many leaflets have too small font size when printed.

For medicines for both humans and animals, we recommend that the leaflets have at least font size 9 to ensure good readability. Criteria for good readability are found in the Guidelines on the Readability of the Labelling and Package Leaflet. These criteria for readability are not limited to specific types of medicine.

Leaflets can be uploaded in Word format to increase readability; it does not have to be the same format as the leaflet in the medicinal package.

The package leaflet uploaded must be the latest version and must contain the date for the last revision.

When we find leaflets with poor readability in our control, marketing authorisation holders will be contacted directly.

References to relevant legislation:

• Guideline on the Readbility of the Labelling and package leaflet of Medicinal Products for Human use
• Bekendtgørelse om ilægning og indsendelse af indlægssedler for lægemidler til mennesker og dyr (retsinformation.dk)
• Veterinary product information (QRD) templates | European Medicines Agency (EMA).
• Europa-Parlamentets og Rådets forordning (EU) 2019/ af 11. december 2018 om veterinærlægemidler og om ophævelse af direktiv 2001/82/EF
• Vejledning om mærkning m.m. af lægemidler til dyr