Company authorisations and registrations

Updated 14 June 2019

Companies wishing to handle medicines and narcotic drugs and psychotropic substances (also called euphoriant substances) must apply to the Danish Medicines Agency for an authorisation. The requirements imposed on the companies aim to ensure that they have a very high standard of quality and thus contribute to a very high patient safety. This means that errors will normally not occur and that the companies will respond quickly and adequately if errors do occur. As for narcotic drugs and psychotropic substances, the purpose is to ensure that these substances are used for medical or research purposes only, and that they do not enter the illegal supply chain.

Inspection

Companies will apply to the Danish Medicines Agency for an authorisation. Usually, the Danish Medicines Agency inspects the company before the authorisation is granted. Once a company has been granted an authorisation, it comes under the so-called risk-based inspection programme.

Authorisations and registrations

There are different authorisations depending on the specific activities. Each type of authorisation imposes specific requirements on the company that it must comply with to maintain its authorisation. 

The Danish Medicines Agency also issues registrations to companies that handle active substances used in the manufacturing of medicines or to those that buy and sell medicines.

Companies and individuals may be punished if they carry out activities with medicines without having the mentioned authorisations and registrations – especially if it involves narcotic drugs and psychotropic substances.

Payment and fees

Companies pay for the review of their application as well as an annual fee to maintain the authorisation.

Legislation

The legal basis for the Danish Medicines Agency’s issuance of authorisations and registrations to companies is established in EU regulations as well as the Danish Medicines Act and the Act on euphoriant substances, etc.

Authorisations

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

Distribution of medicines outside pharmacies, including:

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 a company registration

Fees

An application fee and annual fee are charged for certain company authorisations and company registrations.

You can see all the current fees and find links to the rules on fees on the page Fees payable for medicinal products and companies.

One fee is charged for each site (geographical location) where activities take place.

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