Company authorisations in general

Updated 06 July 2018

We issue company authorisations for the following activities:

manufacture and import of medicines and intermediates

wholesale distribution of medicines within the EU/EEA

distribution of 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)

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