The Danish Medicines Agency is granting authorisations to companies to export medical cannabis after the introduction of new legislation.
According to legislation introduced in January 2019, companies may be granted authorisation to export cannabis products. Such authorisation concerns cannabis bulk and Danish-grown primary products. However, such authorisation is conditional upon the company having previously obtained permission from the Danish Medicines Agency (Lægemiddelstyrelsen) to produce cannabis products.
Export of bulk cannabis
Companies may apply for authorisation to export cannabis bulk. Such companies are required to have previously obtained permission to grow and produce bulk cannabis.
Cannabis bulk is defined as processed cannabis ready for further processing or packaging in consumer-ready packs so it can become a cannabis primary product.
Companies exporting bulk cannabis are subject to the obligation to ensure that their products are solely exported and delivered to companies, which have complied with the import country’s laws regarding cannabis intended for medicinal use. Additionally, exporters of bulk cannabis are obliged to ensure that exported products are traceable and that any errors or deficiencies are investigated and recorded.
Export of medical cannabis primary products
The newly introduced legislation gives companies the opportunity to export Danish-grown cannabis primary products.
Cannabis primary products are a finished cannabis product imported from another country under the pilot programme. Cannabis primary products can be sent to the wholesale distributors and pharmacies by producing a cannabis intermediate product. Several requirements apply to imported products. The term also covers Danish-grown cannabis packed in consumer-ready packs from cannabis bulk. Danish-grown primary products can be exported.
Export of Danish-grown cannabis primary products is limited only to those countries, which permit the import of cannabis for medicinal use. Further, while companies may be granted authorisation to export certain cannabis primary products, such products must not have any affiliation – neither through name nor admission - to the list of cannabis primary products, which is produced by the Danish Medicines Agency.
Cannabis intermediate products
Export of cannabis intermediate products is not allowed under the current regulations. Hence it is important to distinguish cannabis intermediate products from cannabis primary products and bulk.
Cannabis intermediate products are products produced by labelling a primary product according to the rules. Cannabis intermediate products may be sent to wholesale distributors and pharmacies. It is the 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.
If a company wishes to produce cannabis intermediate products, it must apply for a license to produce cannabis intermediate products. Likewise, if a company wishes to import cannabis for the pilot programme, it must apply for a license to produce cannabis intermediate products.
If a company licensed to produce cannabis intermediate products applies to have its products admitted for sale at Danish pharmacies, then these products must be admitted to the Danish Medicines Agency's list.
How can we help?
NJORD’s cannabis lawyers have already assisted several clients in successfully starting their operations under the pilot programme. We help throughout the entire process, from establishing your business and obtaining licenses to developing products and procedures. Contact our team of cannabis lawyers Partner Jeppe Brogaard Clausen and Assistant Attorney Heikki Selin.
