DKMAnet - questions and answers
Which services are available on DKMAnet
The following digital self-services can be used via DKMAnet:
- Submission of changes to prices and packages
- Upload of package leaflets
- Application for general reimbursement
- Application for authorisation for sale of over-the counter medicines
- Application for authorisation to manufactuer and/or import of medicines (GMP-authorisation)
- Application for authorisation of wholesale distribution of medicines (GDP-authorisation)
- Application for authorisation to handle euphoriant substances (EUF-authorisation)
- Application for authorisation to conduct non-clinical trials (GLP-tilladelse)
- Application and changes to clinical trials
- Follow-up on adverse reaction reports.
If your company wishes to use on or more of the above mentioned services, please fill out and submit the "Form for appointment of security administrator" to the Danish Health and Medicines Authority. We will then set up your company as DKMAnet users.
Remember to fill out the Form for ordering of LBC-certifikate if your company is based outside Denmark.
A number of companies are already using the first two services, and they will have to change to the new model of user administration in order to get access to the other services.