DKMAnet: Package Leaflets - questions and answers
We are resuming marketing of a medicine, why is the upload of the package leaflet unsuccessful?
You must change the status to ‘Marketed’ before you can upload a new package leaflet.
Who is responsible for uploading package leaflets to DKMAnet – Package Leaflets?
The marketing authorisation holder (MAH) is responsible for uploading package leaflets to DKMAnet - Package Leaflets.
In the following, we refer to the person/entity handling package leaflets on DKMAnet – Package Leaflets as the ‘company’ regardless of whether this is a representative or the actual MAH.
Must a company notify long-term changes in marketing status on DKMAnet - Package Leaflets?
The company is responsible for changing the status of a medicine to ‘Not marketed’ in connection with long-term cessation of the marketing of a product when this is not caused by deregistration or suspension of marketing authorisation.
A change of marketing status on DKMAnet - Package Leaflets will only be used in relation to DKMAnet - Package Leaflets and thus indlaegesseddel.dk. In other words, it is not considered a notification in the meaning of the Danish Medicines Act, which provides that companies are required to notify changes in marketing status to the Danish Health Authority.
For how long is a package leaflet visible on indlaegseddel.dk after a change of status to “Not marketed”?
The package leaflet will remain on the website for 180 days after the company has changed the status of a medicine to ‘Not marketed’.
This is also the case for the package leaflet of a medicine which may no longer be marketed legally. However, in this case the medicine will no longer be visible on DKMAnet – Package Leaflets.