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.
| 05 July 2012 |
I have problems with making a notification via DKMAnet – Prices & Packages – what should I do? If you have problems with notifying changes in price and product range via DKMAnet – P
| 15 August 2012 |
How does the company gain access to DKMAnet? To gain access to DKMAnet, the user must have a digital employee signature or a CUG signature (foreign users) installed, and then the user must be
| 09 May 2012 |
What advantages will I gain from applying for authorisation of retail sale online? If you apply online, we receive your application immediately and therefore, the reviewing process can be init
| 22 March 2014 |
General Why do I have to use DKMAnet? DKMAnet is a shared portal for applications for clinical trials on medicinal products to both the Danish Health and Medicines Authority and the Scientific Eth
| 09 May 2012 |
What advantages will I gain from applying for a company authorisation online? When you log in to DKMAnet to apply for a company authorisation, the system automatically retrieves information ab
| 07 May 2012 |
How are our questions communicated to others? We forward your questions to the person who reported the adverse reaction, unless it is specifically stated that the questions should be sent else
| 15 November 2013 |
We are resuming marketing of a medicine, why is the upload of the package leaflet unsuccessful? You must change the status to ‘Marketed’ before you can upload a new package leaflet.
| 14 May 2012 |
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 light
| 09 May 2012 |
How high is the level of security in connection with notification to DKMAnet? When notifications are made to DKMAnet, it is crucial to safety that the reporting company only has access to info
| 02 July 2012 |
How do I contact DKMAnet Support? DKMAnet Support are available at: firstname.lastname@example.org or +45 4488 9525. The DKMAnet Support line is open Monday to Friday, 9:30 to 15:00.
| 21 August 2012 |
How are users organised in DKMAnet? From November 2011, companies will be able to manage their DKMAnet users in an other way than today. In the original version, each company had a Company Admi