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 2013, your deregistration request must reach us by Monday 10 December 2012 at 20:00. If we receive your request in time, deregistration of the concerned medicinal product becomes effective on 24 December 2012.
Deregistrations to take effect on 24 December 2012 can be submitted via DKMAnet from Monday 26 November 2012 at 20:00 to Monday 10 December 2012 at 20:00.
Other deregistrations
For companies not yet registered at DKMAnet, the marketing authorisation holder or their representative must notify the Danish Health and Medicines Authority of the Marketings Authorisations to be withdrawn.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 Health and Medicines Authority. Letters concerning Marketing Authorisation withdrawals must reach the Board of Health and Medicines Authority no later than 21 December 2012, to ensure the product(s) are deregistered before the 1st of January 2013.
For questions concerning withdrawal of Marketing Authorisations/deregistration, please write to god-afdelingspostkasse@dkma.dk.
