Company authorisations and registrations

Updated 12 January 2016

Authorisations

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)

Registrations

Companies are required to register the following activities with the Danish Medicines Agency.

Manufacture, import and distribution of active substances

Brokering of medicinal products

Guidelines

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

Guidelines on activities subject to a section 39 authorisation

In the following guidelines, we describe which activities with active substances, medicinal products and intermediate products that require a company authorisation (section 39 authorisation) or company registration.

Note: On 8 September 2014, we added descriptions of the activities ”Transportation of medicines” and ”Purchase and sale of medicines” as well as an overview of the requirements as to the manufacture, import and distribution of active substances.

Guidelines on activities subject to a section 39 authorisation or company registration (PDF file, opens in a new window)

Fees

An application fee and annual fee are charged for certain company authorisations and company registrations. The fees are regulated in to the Danish Executive Order on Fees Payable for Medicinal Products, etc., cf Schedule 1, please see under Fees in the left-hand menu.

One fee is charged for each site (geographical locality) where activities take place. In certain cases, a reduced fee is charged when several authorisations for the same site is applied for. For further information, please see the Danish Executive Order on Fees Payable for Medicinal Products, available under Fees in the left-hand menu.