DKMAnet: reimbursement of medicines - questions and answers
What advantages will I gain from applying for general reimbursement online on DKMAnet?
You do not have to print the whole application and send it by ordinary post. The digital application lightens our administrative workload and facilitates in shortening assessment times as much as possible.
Can I only apply for general reimbursement on DKMAnet?
No, you can also send the application by ordinary post.
How will I receive a decision on my application for general reimbursement via DKMAnet?
Until further notice, the decision will as usual be sent by ordinary post. We can send our decision by email if you write in the application that the decision can be sent by email unencrypted.
Which details are important when I apply for general reimbursement on DKMAnet?
- The medicine (including pharmaceutical form and strengths) for which you are applying for general reimbursement
- Package sizes and consumer prices of the medicine
- Any documents you wish to attach.
What do I do if I cannot find the medicine that I wish to apply for general reimbursement for, on the list of medicines on DKMAnet?
Make sure that you select the correct company when you log in to DKMAnet? If you still cannot find the medicine, you must contact the Danish Medicines Agency, which will be able to check if the marketing authorisation holder and representative are registered correctly.
What does ‘approved indications’ in the application form on DKMAnet mean?
It means the indication(s) for which the medicine has been approved by the authorities, and which is stated in the summary of product characteristics.
Which documentation must I attach to the application for general reimbursement?
- The marketing authorisation
- The summary of product characteristics
- Information about expected consumption (e.g. number of expected medicine users in the primary sector during the first five years from the date of placement on the market or the dateof the general reimbursement application, if this is later, broken down by age and gender (relevant age groups))
- Pharmacological and clinical documentation in the form of copies of e.g.:Clinical assessment reportComparable clinical efficacy and safety studiesScientific papers and relevant reviews accompanied by a summary of the essentials, preferably with argumentation for choice of literature.Do I have to attach a health economic analysis to the application for general reimbursement?
- It is optional to send a health economic analysis. For further information please see: Reimbursement of medicines.
After submitting the application, when can I expect to receive a decision from the Danish Medicines Agency?
The assessment time is usually two to three months. You will receive an acknowledgement for receipt of the application within a week.
Where can I find my application for general reimbursement on DKMAnet?
On the tab ‘Correspondence’ in the top menu when you enter ‘General reimbursement’, you will see an overview of your application(s) and be able to download a PDF that shows the content of the application.