Upload package leaflets to DKMAnet

Updated 02 March 2016

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

To gain access to DKMAnet, companies must appoint a Security Administrator (please see the form in the box).

The appointed Security Administrator must in advance install an employee signature from Nets DanID on his/her computer. The employee signature must be registered in the name of the company.

You can order a digital employee signature from the Nets DanID website.

Security Administrators and users working for companies that do not have a Danish company registration number (CVR number) must be issued a CUG certificate from the Danish Medicines Agency (please see the form in the box).

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)

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