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The Danish Medicines Agency is granting licenses for cultivating, manufacturing, and distributing medical cannabis as the four-year medicinal cannabis pilot programme was established on 1 January In order to cultivate cannabis bulk, manufacture primary and intermediate products, and to distribute the products in Denmark, it is necessary to obtain separate licenses for each process. Furthermore, the manufacturer may distribute the cannabis products when the products have been admitted to the list published by the Danish Medicines Agency. The list allows everyone to see which cannabis products are comprised by the pilot programme. The list shows which products that lawfully may be prescribed by doctors and lawfully dispensed by pharmacies in Denmark. The executive order applies to cultivating cannabis for medical use in Denmark. However, there are different rules applicable to medical cannabis production in Denmark. The executive order establishes that manufacturing of a cannabis intermediate product must comply with the Act on the medicinal cannabis pilot programme. The executive order on the cultivation, manufacturing, and distribution of cannabis bulk, and manufacturing of cannabis primary products allows cultivation of cannabis in Denmark. Furthermore, the executive order makes it possible to apply for a cannabis cultivation license only for medical use. The manufacturers can now choose to cultivate, manufacture, and distribute medical cannabis. Before the provisions in the executive order commenced, it was not allowed to cultivate cannabis bulk with an intent to distribute it to pharmacies. In order to manufacture cannabis primary and intermediate products, a manufacturer must obtain a license. A license to import and manufacture cannabis products can only be issued by the Danish Medicines Agency. A manufacturer does not need to apply for a cultivation license if the manufacturer prefers to acquire primary products from another party. In order to distribute cannabis primary products that are cultivated and manufactured in Denmark, the product must be admitted to the Danish Medicines Agency's list of cannabis intermediate products and cannabis primary products. However, it should be noted that cannabis intermediate products are distributable, as long as they comply with the Danish Medicines Act and the stipulations established in accordance with the executive order on euphoriant substances. The manufacturer of cannabis intermediate products can only distribute cannabis intermediate products to pharmacies, hospital pharmacies, and manufacturers with a license to distribute drugs. In addition, cannabis intermediate products are not allowed to be distributed to manufacturers and persons outside of Denmark. The Danish Medicines Agency is granting authorisations to companies to export medical cannabis after the introduction of new legislation. Additionally, the list shows which products that lawfully may be prescribed by doctors and lawfully dispensed by pharmacies in Denmark. When a cannabis intermediate product is admitted to the list, it can be prescribed by doctors and dispensed by pharmacies in accordance with the pilot programme. The Danish four-year medical cannabis pilot programme along with additional regulations have opened the markets for cultivation, manufacturing and distribution of medical cannabis in Denmark and created new business opportunities for companies. Furthermore, we advise you on, which licenses for medicinal cannabis that are necessary. Additionally, we also assist with the application process. We have all ready assisted clients to successfully start their operations under the pilot programme. There has been a significant change in the approach to medicinal cannabis, and the industry is growing rapidly worldwide. As a first mover in Europe, Denmark has introduced a new legislative framework that provides a unique opportunity for companies to enter the cannabis business. There are many players, the ground rules are complicated, and the entire business area is ever-changing — when it comes to regulation and marketing of the products. A legal collaborator with a strong knowledge of the business area may secure your place in the market. News A license for each process. Read more about the rules on medical cannabis production in Denmark. License to cultivate cannabis. License to manufacture cannabis. License to distribute cannabis. How to export medical cannabis The Danish Medicines Agency is granting authorisations to companies to export medical cannabis after the introduction of new legislation. The Danish medicinal cannabis pilot programme The Danish four-year medical cannabis pilot programme along with additional regulations have opened the markets for cultivation, manufacturing and distribution of medical cannabis in Denmark and created new business opportunities for companies. How can we help? Relevant provisions. Share this on Linkedin. Download PDF. Want to know more? The pilot programme is continued. More Medicinal Cannabis products. What is the status on medical cannabis industry in Denmark ? Latest updates regarding medical cannabis. Export of medical cannabis. The Danish medical cannabis pilot programme creates new business opportunities. How to obtain Danish licenses for medicinal cannabis. We help you navigate the market. Contact us. Legal services. Medicinal Cannabis. Read more. Life Sciences and HealthTech.

How to obtain Danish licenses for medicinal cannabis

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