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Deregistration of medicinal products

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 2012, your deregistration request must reach us by Monday 12 December 2011 at 20:00. If we receive your request in time, deregistration of the concerned medicinal product becomes effective on 26 December 2011.

Deregistrations to take effect on 26 December 2011 can be submitted via DKMAnet from Monday 28 November 2011 at 20:00 to Monday 12 December 2011 at 20:00.

Other deregistrations

For companies not yet registered at DKMAnet, the marketing authorisation holder or a representative must notify the Danish Medicines Agency of the medicinal product(s) to be deregistered before year-end to avoid an annual fee for the subsequent year.

This can be done either by registering at DKMAnet and deregister this way, or by writing to the Danish Medicines Agency before 20 December of the year concerned to give the Agency the time to deregister the product(s) before 1 January of the following year.

For questions concerning deregistration, please write to god-afdelingspostkasse@dkma.dk.

Updated 27 October 2011