Deregistration of medicinal products

Updated 11 October 2018

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 2019, your deregistration request must be submitted to us by Monday 17 December 2018 at 20:00. If we receive your request in time, deregistration of the concerned medicinal product becomes effective on 31 December 2018.

Deregistrations which are to take effect on 31 December 2018 can be submitted via DKMAnet from Monday 3 December at 20:00 to Monday 17 December 2018 at 20:00.

Other deregistrations

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 17 December 2018, to ensure the product(s) are deregistered before the 1st of January 2019.

Special duty to notify medicine supply difficulties

If the deregistration of a medicinal product could lead to serious supply difficulties, the holder of the marketing authorisation must notify the Danish Medicines Agency separately by sending an email to shortage@dkma.dk – in addition to making the actual deregistration of the product. You can read more about the notification duty on the webpage: Serious medicine supply difficulties.

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