Application for authorisation to sell over-the-counter medicines

Updated 22 February 2018

A number of medicines can be sold outside pharmacies:

  • Over-the-counter medicines listed in the Danish Medicines Agency’s register of authorised medicines in dispensing groups HF, HX or HX18.
  • Veterinary medicines (V-marked medicines) listed in the Danish Medicines Agency’s register of authorised medicines in dispensing group HV.

Application

There are several ways to apply for authorisation, see below. We recommend that you apply by using the electronic form or via DKMAnet.

If you use the electronic form, you will, in most cases, receive your authorisation within 15 minutes after you sent the application. However, in some cases it may take a longer time, which you will be informed of when you send the application.

If you apply for authorisation via email or by ordinary post, you should expect a longer assessment time.

Electronic form

This is the easiest and fastest solution for small companies.

Access to the form requires a NemID for companies so that you can log in using your company’s CVR number.

Advarselstrekant NOTE: it may take up to 15 minutes before you receive an e-mail with your authorisation when you use our electronic form.

 

Link to the electronic form (in Danish, opens in new window)

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

Read more about the electronic form in questions and answers (in Danish)

DKMAnet

This is the best solution for large companies that have several addresses under the same CVR number. DKMAnet is the Danish Medicines Agency’s access-controlled extranet. You can find a link to DKMAnet in the External links box to the right.

In order to access DKMAnet, you must have a digital employee signature, and your company must have an appointed security administrator. Read more about access to DKMAnet in DKMAnet - questions and answers

Form for appointment of Security Administrator (SA)

DKMAnet User administration – Guidelines

Application by email and ordinary post

You can also apply for authorisation by email or ordinary post using the application form below.

  • Application form (in Danish): Application for authorisation to sell over-the-counter medicinal products, veterinary medicinal products and/or smoking cessation products outside pharmacies.

We recommend that you send the application form by email to detailtilladelse@dkma.dk

Change of ownership

You can inform us of change of ownership via the electronic form or via DKMAnet.

Alternatively, you can inform us by sending the above application form to detailtilladelse@dkma.dk

E-learning for retail distributors about the handling of over-the counter medicines

In the application, you state that you have completed any relevant e-learning modules about the handling of over-the counter medicines: E-learning about sale of over-the counter medicines

Note that the e-learning modules are only available in Danish.

Limited dispensing status

Colour chart – Sale of over-the-counter medicines with limited dispensing status (HX and HX 18 medicines) (in Danish)

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.