Receipt, acceptance and approval letters

13 February 2019

Letters concerning marketing authorisations

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

Since the date above, the Danish Medicines Agency has used 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, ensuring a high level of security – even higher than for ordinary mail or emails.

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

CMS notifications and variations where the changes applied for have no direct effect in Denmark

As a rule, the Danish Medicines Agency does not send out receipt or acceptance letters for CMS 61.3 notifications. If we require an applicant to take further action, we will contact the applicant in question.

This is also the case for licensing letters for variations if the change has no direct effect in the Danish market; for example a change of the medicinal product name that only has effect in another EU country.