Control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet

Remark:

The Danish Medicines Agency's laboratory will regularly select ATC groups and check whether readable package leaflets have been uploaded to www.indlaegsseddel.dk. The selected ATC groups will not be published in advance.
If the package leaflet is missing on indlægssededdel.dk or if it is not readable, the MAHs/representatives will be notified.

The overall results will be published in anonymised form when available.

The Danish Medicines Agency’s Department for Control and Security of Supply continues the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk in accordance with executive order no. 2429 of 14/12/2021¹ and the guideline on the readability of the labelling².

The following ATC groups are selected: B01, B02, B03, B05 and B06. 

If the package leaflet is missing from indlaegsseddel.dk or if the leaflet is not readable when printed, the representative/marketing authorization holder will be contacted directly. The project is expected to be completed in 2025.

Further information about uploading leaflets can be found on our website under “About us / Digital self-service / About DKMAnet / Upload leaflets to DKMAnet”.
For technical support please contact DKMAnet: DKMAnet@dkma.dk

Questions can be directed to the laboratory: laboratoriekontrol@dkma.dk.

¹ Bekendtgørelse om ilægning og indsendelse af indlægssedler for lægemidler til mennesker og dyr (retsinformation.dk)
² Guideline on the readability of the labelling and package leaflet of medicinal products for human use, 
revision 1, 12 January 2009. Section A.