Questions and answers on the development scheme

Updated 03 April 2018
Theme image medicinal cannabis with tex

Is it still possible to apply for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use (production licence)?

Yes, we review the applications we receive on a continuous basis. The scheme is planned to run for four years from 1 January 2018.

How many pages are needed for the project description?

There is no requirement in this respect. Guidelines on the project description are available on the website of the Danish Medicines Agency.

How long is the review time?

Once we have received an adequate application, it will normally be two to three months before you receive your licence. If we receive numerous applications, the review time could be longer.

How do I import cuttings?

Before any movement of euphoriant substances (including cannabis cuttings) across the national boundaries, a separate import/export certificate for euphoriant substances must be obtained from the Danish Medicines Agency. This certificate must accompany the product. An application form and guidelines on import of euphoriant substances are available on the website of the Danish Medicines Agency (some only in Danish). Be aware that it is punishable to import cannabis cuttings without valid certificates.

Additional rules for companies buying cuttings from countries outside EU:

Cannabis cuttings destined for planting from countries outside the EU are subject to phytosanitary import requirements. The import requirements imply that the plants must be accompanied by a phytosanitary certificate and that the plants will be subject to import control when they are introduced into Denmark. In addition, the import must in advance be notified to the Danish Agricultural Agency, which will subject the plants to import control according to the usual import procedures. The importer pays a user charge for the import control.

Companies importing plants subject to control must also be registered with the Danish Agricultural Agency as importers and will in this connection also be charged an annual registration fee. You can find more information in the Danish Agricultural Agency’s executive order on the import of plants and plant products, etc. (Danish title: Bekendtgørelse om import af planter og planteprodukter m.m.)

Additional rules for companies buying cuttings from countries within the EU:

Plants must be free from quarantine pests, but otherwise there are no other phytosanitary requirements.

Questions about phytosanitary requirements should be addressed to the Danish Agricultural Agency.

How do I import seeds from the cannabis plant?

Seeds from the cannabis plant are not regulated as euphoriant substances. An import certificate issued by the Danish Medicines Agency is therefore not required to import seeds.

Additional rules for companies buying seeds from countries outside the EU:

Seeds must be free from quarantine pests (Schedule 2 of the Danish Agricultural Agency’s executive order on import of plants and plant products, etc. (Danish title: Bekendtgørelse om import af planter og planteprodukter m.m.)) No further phytosanitary requirements are imposed on the import of cannabis seeds from countries outside the EU (third countries).

Additional rules for companies buying cannabis seeds from countries within the EU:

Seeds must be free from quarantine pests, but otherwise there are no other phytosanitary requirements.

Questions about phytosanitary requirements should be addressed to the Danish Agricultural Agency.

What can I do with the cannabis I cultivate under the development scheme?

The cannabis you cultivate may be processed with a view to producing medicinal cannabis that is suitable for the pilot programme. For example, you may therefore dry, cut and process cannabis flowers as well as extract cannabis oils from flowers and other plant components. You can also produce products from the oil or something similar. Companies can also develop consumer-ready packages with medicinal cannabis.

It may be helpful to cultivate and produce several batches of the same product to show that the company is able to produce standardised products with the same content of active substances, etc. Any acceptance of the products for sale at a later stage thus presupposes that product specifications and documentation exist to show that the cultivated and produced products are the same every time.

Note, however, that the cannabis products cannot be supplied to wholesalers or pharmacies as part of the pilot programme. The license does not permit that.

Please also see the section about destruction.

When will Danish cultivation be regulated so that supplies can be made to pharmacies and for export?

The act on the medicinal cannabis pilot programme provides that the Minister of Health can lay down rules on the requirements for cultivation, production, control and export, etc. of cannabis cultivated in Denmark. These rules will enter into force on 1 July 2018. We advise you to stay updated via the Danish consultation portal høringsportalen where the rules will be submitted for public consultation prior to publication and entry into force.

You should be aware that your company must obtain approval from the Danish Medicines Agency for each medicinal cannabis product you want to distribute on the Danish market. In this connection, you must also price your product. The doctors’ prescription choices and the free market forces will decide which products will be prescribed by the doctors and thus bought from the pharmacies. It is therefore likely that companies will compete with other Danish companies cultivating and producing medicinal cannabis in Denmark. It is also likely that they will compete with companies that import medicinal cannabis from other countries, including Holland.

How do I maintain records of euphoriant substances in respect of the cannabis I handle?

General information about record keeping of euphoriant substances is provided on the website of the Danish Medicines Agency under euphoriant substances.

To whom may I sell the cannabis I cultivate?

The cannabis produced under the development scheme may only be sold/distributed to companies holding a relevant licence under the development scheme and authorised to handle euphoriant substances.  The purpose of the sale/distribution must still be to develop and process the product with a view to including it in the pilot programme.

The Danish Medicines Agency will indicate on the individual production licence to which named company(ies) you may sell or hand over cannabis based on your application/project description. Cannabis may not be distributed to others.

Export

After the consultation in spring, the final rules will be laid down on the cultivation of cannabis in Denmark with effect from 1 July 2018. Rules on the export of cannabis primary products will be established at the same time.

What should I do if the company changes name, managing director or responsible leader?

Any changes to the information based on which the authorisation was granted must be notified to the Danish Medicines Agency and approved via issue of a new authorisation before the changes can take effect.

To apply for the change, companies must use the application form available on the website of the Danish Medicines Agency and tick off “ændring af tilladelse” (change of authorisation).

What if we want to cultivate or handle cannabis at a different site address than the one indicated on the authorisation?

Any changes to the information based on which the authorisation was granted must be notified to the Danish Medicines Agency and approved via issue of a new authorisation before the changes can take effect.

To apply for the change, companies must use the application form available on the website of the Danish Medicines Agency and tick off “ændring af tilladelse” (change of authorisation).

Please be aware that it is punishable to cultivate, store or handle cannabis at a site address that is not covered by the authorisation.

What if the company is only changing its CVR number (central business registration number)?

If changing the company’s CVR number is the only change made to the information based on which the authorisation was granted, then it is sufficient to notify the Danish Medicines Agency of the change without applying to change the authorisation.

What are the safety requirements?

The company must ensure that access is restricted. Unauthorised persons may only access the premises where cultivation, production or handling of cannabis take place if they are duly escorted.  

The Danish Medicines Agency is working together with the police to set out guidelines on relevant considerations about safety-related risks with measures to be taken to counter these risks.

Will our company be inspected by the Danish Medicines Agency?

Generally, a company that applies for a licence under the development scheme will not be inspected, but we will go through a number of questions about premises, staff, etc. as part of our review process to ensure that the company complies with the applicable rules.

The company can expect to be inspected at a later stage after the licence has been issued. Normally, we will give you good notice before a planned inspection, and the inspection will focus on whether the company complies with the rules on handling euphoriant substances. Be aware that violation of the rules on handling euphoriant substances is punishable.

Destruction of cannabis under the development scheme

If you need to destroy cannabis, you must follow the same rules that apply to the destruction of euphoriant substances. You can read them on our website. It is important to know that you need an authorisation to destroy euphoriant substances, including cannabis.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.