Company authorisations

The Danish Medicines Agency issues company authorisations for the following activities:

• manufacture and/or importation of medicines and intermediates
• wholesale distribution of medicines within the EU/EEA
• retail sale of non-pharmacy restricted medicines outside pharmacies, including over-the-counter medicines (HF, HX, HX18), V-marked medicines (HV), medical gases (GH) and medicines for production animals (HP, HPK)
• blood bank activity
• handling of tissues and cells
• handling of euphoriant substances
• handling of radiopharmaceuticals in hospitals
• conduct of toxicological and pharmacological trials (non-clinical trials)

Application

Application via DKMAnet

Applications for company authorisation for manufacture, importation and wholesale distribution of medicinal products, handling of euphoriant substances and conduct of toxicological and pharmacological trials can be submitted online via the Danish Medicines Agency's extranet, DKMAnet.

In order to access DKMAnet, you must have a digital employee signature, and your company must have an appointed security administrator. In the box to the right, you can find forms for the appointment of a Security Administrator, a guideline on application for authorisation as well as prolongation of authorisations via DKMAnet.

Application via email

You can also apply for company authorisation via email by means of the application forms under each area in the left-hand menu. If you do so, we prefer that you send the application form electronically to virksomhedstilladelse@dkma.dk.

Guidelines

Companies can find general guidance on application for company authorisations in: Guidelines on requirements and deadlines for applications for company authorisations (PDF file)

Specific guidance, application forms and other relevant information for the different types of company authorisations are available under the different areas in the left-hand menu.