Deregistration of medicinal products
Different deadlines for the deregistration of medicinal products (not packages) apply, depending on whether the marketing authorisation holder or the representative has access to DKMAnet.
We generally accept the receipt of deregistrations during the course of the year. It is important to deregister medicinal products in time especially at the turn of a year to avoid having to pay an annual fee for the product in the subsequent year.
If the medicinal product is still registered on the first day of the year, an annual fee for the full year will be charged regardless of the time of the year the product is deregistered.
Deregistrations via DKMAnet
You must submit your deregistration via DKMAnet at least two weeks before the deregistration is to become effective.
Year-end deadline for deregistrations via DKMAnet
For deregistrations of medicinal products to take effect at the close of 2024, we must receive the notification on or before Monday 9 December 2024 at 20:00. This enables deregistration to take place before 1 January 2025. If we receive the notification in time, the deregistration of the medicinal product takes effect from 23 December 2024.
Deregistrations, with the effective date of 23 December 2024, can be submitted via DKMAnet from Monday 25 November 2024 after 20:00 to Monday 9 December 2024 at 20:00.
Other deregistrations
This is done either by registering as a user of DKMAnet and completing the deregistration through this channel or by writing to the Danish Medicines Agency. The Danish Medicines Agency must receive the letter on or before 9 December 2024 for the medicinal product to be deregistered before 1 January 2025.
Special notification duty in the event of medicines supply shortages
Because the deregistration of medicinal products could lead to a serious supply shortage, the marketing authorisation holder must in addition to the above also notify the Danish Medicines Agency separately in the case of permanent cessation of marketing in compliance with the statutory notification duty. Read more about this on this page: Notification duty in the event of medicines supply shortages.