News about Licensing and supervision

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

Information for marketing authorisation holders (MAH). The Danish Medicines Agency's laboratory carries out regular control of companies’ upload of package leaflets to the Danish Medicines Agency’s portal DKMAnet (www.indlaegsseddel.dk). The control ensures, that users of medicinal products have access to an electronic package leaflet, if the physical package leaflet is not available. We check: • Whether the package leaflet is uploaded? • Whether the package leaflet is printable? • Whether the package leaflet is readable when printed out? • Whether the electronic package leaflet contains a date of latest revision? A control project was recently completed for ATC codes R01, S01-03. 5% of the uploaded package leaflets were flawed and the marketing authorization holders involved are in the process of correcting the errors. In general, we encourage marketing authorization holders to test whether the uploaded package leaflets are readable when printed to ensure user-friendliness. We made 241 searches on “Indlaegsseddel.dk” for ATC codes R01 and S01-03, which cover medicinal products for diseases of the nasal cavity and eye and ear diseases. In particular, we observed that the font size of several package leaflets was smaller than point 9 according to the Readability Guideline.