Medicinal cannabis pilot programme
On 1 January 2018 it became possible to obtain a licence to import cannabis for Danish patients in the pilot programme The rules regulating these activities appear from the executive order on the import of cannabis primary products and production of cannabis intermediate products. It also became possible for companies to apply for a licence to develop medicinal cannabis that cannot be dispensed to patients, but according to which the company can cultivate, develop and test medicinal cannabis. You can read more about this under the Development scheme.
Since 1 July 2018, it has also been possible to apply for a licence to cultivate medicinal cannabis in Denmark for inclusion in the pilot programme. The rules appear from the executive order on the cultivation, production and distribution of cannabis bulk and production of cannabis primary products.
These rules apply within the medicinal cannabis pilot programme, which runs for a period of four years from 1 January 2018. The executive order has been issued pursuant to the Act on a Medicinal Cannabis Pilot Programme.
A number of terms are used in order to apply different rules to the various stages of the products in the pilot programme. In summary:
Cannabis bulk: Processed cannabis ready for further processing (e.g. for extraction of cannabis oil) or for packaging in consumer-ready packs so it can become a cannabis primary product.
Cannabis primary product: A finished cannabis product from another country that can be imported to the pilot programme, and which can be sent to wholesale distributors and pharmacies by producing a cannabis intermediate product. A number of requirements apply to the imported product. The term also covers Danish-grown cannabis packed in consumer-ready packs from cannabis bulk. The Danish-grown primary products can be exported.
Cannabis intermediate product: Produced by labelling a primary product according to the rules. May be sent to wholesale distributors and pharmacies. It is cannabis intermediate product manufacturers who have their products admitted to the Danish Medicines Agency's list of products admitted to the pilot programme, and who apply for a name for each product.
Cannabis end-product: Produced from a cannabis intermediate product. The finished cannabis end-product may be dispensed to a specific patient according to a doctor's prescription. It is a pharmacy or a hospital pharmacy that is responsible for this final stage of production.
The exact definitions and other terms appear from the act and the two executive orders mentioned above.
It requires a licence to import, cultivate and produce the mentioned products, and every licence must be adjusted to the activities that the company seeks to perform. Before a company can be issued a licence, it will be inspected by the Danish Medicines Agency.
Application for licence and admission of products to the list
If a company wishes to cultivate cannabis and produce cannabis bulk from the cultivated cannabis, it must apply for a licence to produce cannabis bulk.
If a company wishes to produce cannabis primary products or intermediate products, it must apply for a licence to produce cannabis intermediate products. Likewise, if a company wishes to import cannabis for the pilot programme, it must apply for a licence to produce cannabis intermediate products.
If a company licensed to produce cannabis intermediate products seeks to have its products admitted for sale at Danish pharmacies, then these products must be admitted to the Danish Medicines Agency's list.
Authorisation of activities with euphoriant substances
Besides these licenses, the company must also apply for an authorisation to handle euphoriant substances covering the company's activities. Cannabis is thus covered by the executive order on euphoriant substances (Schedule A, no. 1). When you handle euphoriant substances, you must comply with the executive order; for example, there are requirements for import and export certificates, authorisations for destruction, record-keeping of euphoriant substances, etc.
Companies should be aware that any violation of the rules on euphoriant substances is punishable.
Please see more under Activities with euphoriant substances.
Requirements for companies
The requirements imposed on companies depend on the activities the company will be allowed to perform. These requirements are specifically to ensure that only cannabis products of a sufficiently high quality are dispensed for the treatment of patients. When companies cultivate cannabis, they must comply with the rules on good agricultural and collection practice (GACP), and when they produce cannabis products, they must comply with good manufacturing practice (GMP). Most companies employ specialists and consultants to ensure continuous compliance with these strict rules.
The Danish Medicines Agency monitors whether the companies meet the requirements and follow their own procedures. One of the ways we do this is through inspections where our inspectors will pay visits to the companies.
Development of medicinal cannabis
If instead your company wishes to apply for a license to develop medicinal cannabis that cannot be handed out to patients, but according to which you can develop and test the company’s own methods, please see the information under the Development scheme. Once the company is ready to comply with the rules on GACP and GMP, it can apply for licenses under the pilot programme for dispensing to patients.