Error in company names and marketing status at www.indlaegsseddel.dk

The Danish Medicines Agency is aware that an incorrect company name and marketing status are shown for some medicines at www.indlaegsseddel.dk.

Explanation

During the transfer to a new IT system, there was a bug in the update of the company names in the database providing data to www.indlaegsseddel.dk. As a result, some medicines are showing an incorrect company name at www.indlaegsseddel.dk and an incorrect status of “not marketed”.

Extent and consequences

The error affects about 60 different companies listed at www.indlaegsseddel.dk.

The bug does not affect our central register of medicinal products and if a new package leaflet is uploaded to www.indlaegsseddel.dk via DKMAnet, it will contain the correct company name for the new package leaflet.

Should companies do anything?

The Danish Medicines Agency has decided not to ask the affected companies to upload their package leaflet again, the reason being that uploading a new version of the package leaflet is not going to replace the existing package leaflet with the incorrect company name and marketing status.

However, if the content of a package leaflet has changed, a new one must of course be uploaded as normal.

Plan and further information

We are currently identifying which package leaflets are affected by the bug and checking if changes have been made for them after the bug to make sure these are preserved when we fix the bug.

In connection with the bug fix, we may need to temporarily close the access to uploading package leaflets to DKMAnet. You will be informed in good time via this and other channels. If you need further instructions, please send an e-mail to dkma@dkma.dk.