Questions and answers on the development scheme

Yes, we review the applications we receive on a continuous basis. The scheme is planned to run until 31 December 2025.

No, this is not a precondition. The authorisation to cultivate and develop medicinal cannabis is an opportunity for companies to build up competence and develop methods and products within medicinal cannabis for use in the pilot programme. The authorisation does not permit companies to supply products for use by patients.

After holding a development authorisation for a period of time, some companies decide to apply for an authorisation to cultivate cannabis and manufacture cannabis bulk pursuant to which they can manufacture products for patient use and for export. Before they can obtain this authorisation, the Danish Medicines Agency must validate the application and inspect the company to ensure it fulfils the requirements of the Act on a Medicinal Cannabis Pilot Programme, including the principles of good manufacturing practice (GMP) and good manufacturing practice (GMP).

It is possible to apply straight away for an authorisation to manufacture cannabis bulk, including cultivation of medicinal cannabis. But very few companies choose this path, because the development scheme is a good way of getting started with cannabis cultivation quicker and building up competence in the process.

There is no requirement in this respect, but we encourage you not to use more than 20 pages (corresponding to the Site Master File for an application under the pilot programme). Guidelines on the project description are available on the website of the Danish Medicines Agency.

Once we have received a complete application, the application and project description will be assessed by the Danish Medicines Agency, the Danish Agricultural Agency and the Danish National Police. Next you will be contacted by the Danish Medicines Agency’s inspectors who will inspect your premises for approval. If the inspection is completed satisfactory, you will receive an authorisation. We make every effort to observe an assessment time of maximum 90 days. But delays are possible if something is missing in your application, and we need you to provide further information or if, at the time of applying, you are not ready for an inspection. To avoid this, it is important that you follow the application and project description guidelines. It will make the assessment easier and thus faster.

As part of our review, we ask the Danish National Police to perform an assessment of good conduct. This check is run with the consent of the line manager and the managing director of the company. If the Danish National Police comes back to us confirming that there is nothing in their records preventing the granting of the authorisation, then we continue our assessment.

However, if the Danish National Police finds matters in their own or other public registers that speak against the issue of the authorisation, we inform the affected person about the information we hold about this person before we inform the company that the authorisation cannot be granted on the basis presented. The company will often be able to rearrange ownership or the management, in which case we will submit the new application with new information to the Danish National Police.

You can file a complaint against our rejection, but you cannot complain against the recommendation of the Danish National Police. We usually follow the recommendation of the Danish National Police.

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. The 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 non-EU countries:

Cannabis cuttings intended for planting coming from non-EU countries 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 EU countries:

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.

Seeds from the cannabis plant are not a controlled euphoriant substance. An import certificate issued by the Danish Medicines Agency is therefore not required to import seeds.

Additional rules for companies buying seeds from non-EU countries:

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 non-EU countries (third countries).

Additional rules for companies buying cannabis seeds from EU countries:

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.

The cannabis you cultivate can be processed with a view to producing medicinal cannabis that is suitable for the pilot programme. For example, you may trim, dry and process cannabis 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. It is a requirement that uniform products can be produced when the company is to produce products for the pilot programme. Admission of products to the pilot programme presupposes that product specifications and documentation exist to show that the cultivated and produced products are homogeneous, i.e. identical from one batch to the next.

The cannabis products produced under the development scheme can neither be supplied to wholesalers or pharmacies nor exported. Only cannabis cultivated on the basis of a cannabis bulk manufacturing authorisation can be used to make products for admission to the pilot programme. Not before the issue of this authorisation is patient safety sufficiently documented for the products to be made available for patient treatment.

Please also see the section about destruction.

The cannabis produced under the development scheme may only be sold/distributed to companies holding a relevant authorisation under the development scheme. The purpose of the sale/distribution must still be to develop and process the product further with the aim of including it in the pilot programme. Please also see the section about cuttings. Cannabis cultivated under the development scheme can be sent for analysis at companies holding a relevant authorisation to handle euphoriant substances on the A List, cannabis.

Yes, under the development scheme, you can sell/distribute cuttings of the cannabis plant or components of cannabis for vegetative reproduction to other companies holding an authorisation under the development scheme. But neither distribution to the pilot programme nor export is permitted.

To apply for this activity, you should tick off “Videregivelse inden for udviklingsordningen” (distribution within the development scheme) on the application form. The application must also name the company to which distribution is to take place, and the relevant authorisation for this company must be enclosed.

Cannabis in the development scheme may not be exported, with the exception of samples for testing. For each export consignment, you must apply to the Danish Medicines Agency for an export certificate and ensure that the company you are exporting the product to holds an authorisation to handle medicinal cannabis in the country in question.

Please note that any breach of the ban on export, including lack of certificates, is punishable.

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

In connection with an application to vary an existing authorisation, you should use the application form available on the website of the Danish Medicines Agency and tick off “ændring af tilladelse” (change of authorisation).

Please note that any new persons will be subjected to an assessment of good conduct.

No. We only issue authorisations after our inspectors have inspected the premises at the address where cultivation and production are to take place. On the application form, this is called “lokation for håndtering” (handling site). This means that an authorisation is linked to the specific site address where the activities take place.

Any changes to the information based on which the authorisation was granted must be notified to the Danish Medicines Agency and approved via the 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). The new address will need to be inspected before the authorisation can be granted.

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

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.

The company must ensure that access is restricted. Unauthorised persons are only permitted to enter the premises where cultivation, production or handling of cannabis take place if duly escorted. The company is expected to have performed a risk assessment to determine any security measures needed, i.e. an assessment of the risk associated with your cultivation and/or production activities, including site access, staff, camera surveillance, alarm system, keys/codes, etc. See further information in our Recommendations for security of companies that manufacture medicinal cannabis (PDF) (in Danish only).

Yes, the Danish Medicines Agency will pay an inspection visit to the company in the case of new applications. If the application concerns a change to an existing authorisation, we will determine whether an inspection is necessary in the individual case.

Companies should also expect to be inspected regularly after the authorisation has been granted. 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 the handling of euphoriant substances and the company’s project description. Please note that any breach of the rules on the handling of euphoriant substances is punishable.

In case of serious breaches of the rules, we may also suspend the company’s authorisation as a whole or in part for a period of time.

Read more here: Destruction and record-keeping for companies authorised to cultivate cannabis for medicinal use (PDF) – in Danish only

If you need to destroy cannabis, you must follow the same rules that apply to the destruction of euphoriant substances. These rules are available on our website. Note that you need an authorisation to destroy euphoriant substances, including cannabis.

Read more here: Destruction and record-keeping for companies authorised to cultivate cannabis for medicinal use (PDF) – in Danish only