Company authorisations in general
We issue company authorisations for the following activities:
manufacture and import of medicines and intermediates
wholesale distribution of medicines within the EU/EEA
handling of euphoriant substances
radiopharmaceuticals in hospitals
conduct of toxicological and pharmacological trials (non-clinical trials)
manufacture of cannabis products
Guidelines
Companies can find general guidance on application for company authorisations in:
Guidelines on requirements and deadlines for applications for company authorisations
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.
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 our extranet, DKMAnet.
In order to access DKMAnet, you must have a digital employee signature, and your company must have an appointed security administrator.
Forms for the appointment of a Security Administrator, a guideline on application for authorisation as well as prolongation of authorisations via DKMAnet:
Form for appointment of Security Administrator (pdf - 0.07 MB)
DKMAnet - User administration - Guidelines (pdf - 0.08 MB)
Order for Closed User Group Certificate (CUG) for logon to DKMAnet (pdf - 0.06 MB)
Company authorisations on DKMAnet - questions and answers
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 Send an email.