Upload package leaflets to DKMAnet

Indlaegsseddel.dk and upload to DKMAnet

The Danish Medicines Agency ensures that package leaflets for medicinal products sold in Denmark are available to the public indlaegsseddel.dk

Pharmaceutical companies must upload current package leaflets to the package leaflet database via the Danish Medicines Agency's extranet DKMAnet. From here, the package leaflets are made available at indlaegsseddel.dk

Here you can find out how to upload package leaflets to the database via DKMAnet.

How to gain access to DKMAnet

Each user of DKMAnet must use a digital certificate for identification in order to log on to the system. Employees in Danish companies must use MitID Erhverv. MitID Erhverv can be ordered via the MitID Erhverv website.

Users employed in companies that do not have a Danish company registration (CVR) number must be issued a Closed User Group (CUG) certificate from the Danish Medicines Agency.

Order for Closed User Group Certificate (CUG) for log-on to DKMAnet

In addition, each user must have a user account on DKMAnet - with information about the certificate - specifying which data and functionality the user can access.

The company must start by appointing a security administrator for DKMAnet (see the form in the box). The Danish Medicines Agency will create the user account for the security administrator.

The security administrator may then create user accounts for any additional users that the company would like to have on DKMAnet and specify their access rights.

DKMAnet - Package Leaflets

Users on DKMAnet will be presented with an overview from the Danish Medicines Agency's database of medicinal products in connection with upload of package leaflets. The overview shows package leaflets for all of the company's authorised medicinal products. Companies can at any time upload new package leaflets.

By extracting data from the database of medicinal products, we make sure that the overview is maintained automatically in connection with name changes, sale of medicinal products between companies, deregistration of medicines, etc.

Please note that medicines that are to be included in Medicine Prices will not appear on the list until they are or have been notified to DKMAnet – Prices & Packages.

Executive order

Executive order on submission of package leaflets to the Danish Medicines Agency (in Danish)