Receipt, acceptance and approval letters

Letters concerning marketing authorisations

As of 20 February 2018, the Danish Medicines Agency changed its procedure for sending letters concerning marketing authorisations.

The Danish Medicines Agency uses digital post to send all letters concerning marketing authorisations to Danish companies.

This includes all letters about new marketing authorisations, variations and renewals as well as any annexes – in the human and veterinary fields.

Every letter we send by digital post is encrypted. 

Letters to companies outside Denmark will still be sent by Eudra-link.

To establblish an Eudralink account you must first have an EMA account: https://register.ema.europa.eu/identityiq/home.html

Once this account is created, you may apply for an Eudralink account via the following link: https://eudralink.ema.europa.eu/

Please use a general company email address for the Eudralink account, as personal email addresses often require frequent maintenance and updates.

Documents received via Eudralink will be accessible for 3 months from the date of receipt.