DKMAnet: information about medicinal products - questions and answers
What if I cannot find the medicinal product in DKMAnet?
If you cannot find a specific medicine in DKMAnet, it could be due to one of the following:
- You have not been set up as a user in DKMAnet with rights to handle package leaflets.
- You have not been set up as a user of the company which the Danish Medicines Agency has registered as the representative for the product.
- Medicines to be listed in DKMAnet – Prices & Packages are not included on the list until notification has been made through DKMAnet and the Danish Medicines Agency has handled the notification. Your notification has probably not been finalised.
- The Danish Medicines Agency may have received and approved a variation application from your company. This means that we have registered new information about the name of the medicine, or company in our database.
- The medicine may have been deregistered or the marketing authorisation temporarily suspended.
Our marketing authorisation for a medicinal product is no longer suspended. Why is the status still set to ‘Not marketed’?
While the marketing authorisation is suspended, the medicine is not shown on DKMAnet – Package Leaflets. The status at indlaegsseddel.dk will read ‘Not marketed’.
Once the suspension has been lifted, the medicine will reappear on DKMAnet – Package Leaflets, yet with the status ‘Not marketed’.
When your company resumes the marketing of a product, you must change the status to ‘Marketed’ yourself.
Is it possible to assign differentiated access to the company's medicinal product range?
Differentiated user access is possible if the company product range is linked to several company numbers - which will often be the case if, for instance, the company has been through one or several mergers and now consists of several companies.
In such cases the company administrator may for instance give one company user access to one company number (and thus to the part of the product range linked to the company number in question) and give another company user access to another/several other company number(s).
The company administrator will always have access to all the company numbers and product ranges for the companies, for which he/she is appointed company administrator.
The need for differentiated access may be of relevance if a company user is only to have access to make notifications for part of the company product range.
The Danish Medicines Agency does not know the company's company users, only the company administrator.
If you have been set up as a company user, please contact your company administrator if you have questions about your access or request changes.
My company has been authorised by the Danish Medicines Agency. Why are my company's medicinal products not registered under the address?
Even though your company has been authorised by the Danish Medicines Agency in connection with an inspection of the company's facilities, this does not mean that we register your company's medicines under that address.
Your company must submit a variation application to have your company's medicines registered under the new address.
Read more about variation applications: Application for variations
If you take over medicines from another company, please contact the company which is transferring medicines to you and ask them to submit a variation application. The Danish Medicines Agency will then update the address information of each individual medicine.
Read more about variation applications: Application for variations