Deregistration of medicinal products

Updated 26 October 2015

The deadline for deregistration of medicinal products (not packages) depends on whether the marketing authorisation holder or a representative has access to DKMAnet.

In general, requests for deregistration of medicinal products can be submitted throughout the year. However, if companies want to avoid paying the annual fee for a medicinal product for the subsequent year, deregistration must be done in time before year-end.

If the medicinal product is still registered on the first day of a new year, the annual fee will be charged for the entire year, regardless of what time of the year it is deregistered.

Deregistration via DKMAnet

Requests for deregistration must be submitted via DKMAnet no later than two weeks before the deregistration is to become effective.

Submission deadline for deregistrations via DKMAnet

To make sure that deregistration of medicinal products takes place before 1 January 2016, your deregistration request must be submitted to us by Monday 7 December 2015 at 20:00. If we receive your request in time, deregistration of the concerned medicinal product becomes effective on 21 December 2015.

Deregistrations which are to take effect on 21 December 2015 can be submitted via DKMAnet from Monday 23 November 2015 at 20:00 to Monday 7 December 2015 at 20:00.

Other deregistrations

For companies not yet registered at DKMAnet, the marketing authorisation holder or their representative must notify the Danish Medicines Agency of the Marketing Authorisations to be withdrawn. This applies only for non-marketed pharmaceutical products, i.e. products without active or deactivated packages.

Withdrawal of Marketing Authorisations can be done using DKMAnet or by writing to the Danish Medicines Agency. Letters concerning Marketing Authorisation withdrawals must reach the Danish Medicines Agency no later than 18 December 2015, to ensure the product(s) are deregistered before the 1st of January 2016.

For questions concerning withdrawal of Marketing Authorisations/deregistration, please write to god-afdelingspostkasse@dkma.dk.