DKMAnet: Security - questions and answers
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 information about its own product range and that the submitted changes cannot be seen by others than that company.
SSL encryption according to internationally recognised security standards is used for submitting data.
In order to ensure the highest level of security, the users must log on using an employee signature (OCES standard) as identification to the system.
Users are automatically disconnected after 15 minutes’ inactivity in Prices & Packages.
All log-on attempts and activity in DKMAnet are logged.
How does the Danish Health and Medicines Authority ensure that the information shown is correct?
The linkage between company and medicines range is established by means of the company number(s) that we have assigned to your company.
The company numbers – our key to the companies' product ranges and information on company authorisations – must also be stated on the form which must be completed to gain access to DKMAnet (Form for Appointment of Security Administrator).
Can the Danish Health and Medicines Authority access DKMAnet?
The employees of the Danish Health and Medicines Authority do NOT have access to submit data on behalf of the companies in DKMAnet, nor can they log in as a company and see the company’s data.
However, the employees of the Danish Health and Medicines Authority have access to an activity log in DKMAnet, and in case of doubt, they will be able to document an action with identification of user ID, date, time and action.
In DKMAnet - Prices & Packages, the notifications are not transferred to the Danish Health and Medicines Authority's internal system until after the notification deadline (every other Monday after 20:00).
My company has medicines for both human and veterinary use distributed on different company numbers in the Danish Health and Medicines Authority's database? Is it possible to have the medicines for human use and veterinary use, respectively, linked to their respective company numbers?
Yes, you can have your company's medicines registered so that medicines for human use and veterinary use are registered under two different company numbers.
The motivation for such division must be that two different companies act as Marketing Authorisation Holder, representative or parallel distributor, respectively, of the medicines in question, for instance NewMedicin A/S and NewMedicin Animal Health. You can have your product range divided by submitting a variation application.
The Licensing Division of the Danish Health and Medicines Authority reviews variation applications and can answer questions about the administrative procedure.
You can find out more about variation applications: Application for variations.
You do not have to submit a variation application if you have documentation that the medicines you wish to transfer from one company number to another have been registered incorrectly.
Perhaps you consider our information incorrect compared to your previously submitted application or perhaps a variation application is presently being reviewed by the Danish Health and Medicines Authority.
Please contact DKMAnet Support on +45 4488 9525 or firstname.lastname@example.org for information on how to proceed.