DKMAnet: company authorisations - questions and answers

Updated 13 September 2016

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 about the activities approved on your company authorisation.

This means that the application form is filled with the information we already know. As a result, the application process will in most cases be simpler.

On top of that, you can log in to DKMAnet at any time to find and download a submitted application.

Finally, DKMAnet gives you an overview of when your company's authorisations expire.


Who can apply for company authorisations on DKMAnet on behalf of my company?

The persons in your company who have been assigned the role of company user with access to company authorisations.

Note that a company administrator with access rights to company authorisations must set up himself/herself as user (under user administration) in order to be able to submit applications.

Please also see Access to DKMAnet - questions and answers.


How do I renew my company authorisation on DKMAnet?

Once you have logged in via the DKMAnet frontpage, you then select the type of company authorisation that you wish to renew and then the action Renewal from the Overview.


Is it only possible to apply for a company authorisation online via DKMAnet?

No, it is still possible to send applications by filling in an application form in Word and sending it to Send an email.


Can I find my company authorisation on DKMAnet?

No, we are working to expand two-way communication on DKMAnet, so that you in future can find your company authorisation here.


Where can I find information about the fees charged for company authorisations?

The fees are available in the Guidelines on requirements and deadlines for applications for company authorisations under Company authorisations.


Where can I find information about the validity of company authorisations?

This information is available in the Guidelines on requirements and deadlines for applications for company authorisations under Company authorisations.


Can I apply for a company authorisation for several sites at the same time?

Yes, on the application form on DKMAnet, you can indicate which sites you wish yo apply for. On the application form, you are able to choose the sites attached to the main company, and you can add more if necessary.


When can I apply to renew my company authorisation?

You can apply to renew an authorisation six months before it expires. Please also see the Guidelines on requirements and deadlines for applications for company authorisations under Company authorisations


What happens when I have applied for a company authorisation via DKMAnet?

When you submit an application for a company authorisation, a new case is started in the Danish Medicines Agency.

If the application concerns a new company, or if it requires an  inspection, the Danish Medicines Agency will schedule an inspection visit before the authorisation can be issued.

It takes between 30-90 days to review the application depending on its nature.


Who will the Danish Medicines Agency contact if it has questions about my application?

The Danish Medicines Agency will contact the person in the company having submitted the company authorisation via DKMAnet.


What if I cannot find the medicine on DKMAnet?

If you cannot find a specific medicine on DKMAnet, it could be due to one of the following:

  • You have not been set up as a user on 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.
  • Maybe, the Danish Medicines Agency has 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.

If you cannot find one of your company’s medicines on DKMAnet – Package Leaflets, please contact Kirsten Astrup, Send an email, at the Danish Medicines Agency.


Our marketing authorisation for a medicine 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 range of medicines?

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 medicines 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.

You can find out 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.

You can find out more about variation applications: Application for variations.

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