Electronic dispatch of decision letters marks its fifth anniversary

Since 1 February 2021, the Danish Medicines Agency has been issuing decision letters on applications for marketing authorisations electronically and securely.

Pharmaceutical companies or contacts based in Denmark

receive material via Digital Post (e-Boks).

Pharmaceutical companies or contacts outside Denmark

receive material via EudraLink, which is the European Medicines Agency’s (EMA) secure file transfer system for document exchange.
To receive files via EudraLink, a EudraLink account is required.Create a user account on the EMA website, and next submit a request for a EudraLink account via the EMA Service Desk Portal. The account is usually created within a few hours.

Issuance of the marketing authorisation

The marketing authorisation letter and the corresponding product information (SmPC) are sent to the marketing authorisation holder.
The method of dispatch depends on the holder’s location: Digital Post (e-Boks) for holders in Denmark, and EudraLink for holders outside Denmark. To ensure correct delivery via EudraLink, the email address provided in the application form must be valid.

After the marketing authorisation is issued

For subsequent procedures – including variations, notifications, and renewals – the Danish Medicines Agency sends the decision letter to the contact person specified in the application form.
The method of dispatch depends on the contact person’s location: Digital Post (e-Boks) for contact persons in Denmark, and EudraLink for contact persons outside Denmark. To ensure proper delivery via EudraLink, the provided email address must be valid.

Read more

Information about completion of applicant, contact person and representative in the application form