Do you know how to become a licensed producer in Denmark?
Cannabis Cultivation Licensing in Denmark
Cannabis legalization is expanding worldwide. Investors and growers are taking notice and exploring how they might get their medical cannabis cultivation license, most recently in Denmark. While some countries like Denmark opt only for medical access to cannabis, others are opening the market for recreational use. This new global demand for cannabis is encouraging international collaboration to establish companies that can produce reliable cannabis products with legal integrity. Denmark is now working with cultivators to develop and implement a legal pathway to medical cannabis production and sales. Continue reading for a comprehensive guide to help you become a licensed cannabis producer in Denmark.
In 2018, Denmark introduced a medical cannabis pilot program to their nation. This program allows companies to be licensed cannabis producers, handlers, and exporters through their trial program. There is also a license for development that can be obtained that is similar to a research license where the cannabis that is grown is not for sale. Denmark defines hemp as cannabis with less than 0.2% THC and manages its cultivation through the Danish Agricultural Agency. Cannabis, which has more than 0.2% THC is licensed and managed separately.
The application form "Application for a cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use" is used to apply for a medical cannabis production license. The form is very brief and simple, but it is only available in Danish, so if you are a foreign investor you will need to enlist local assistance. Additionally, while the form is brief, it requires a project description that is quite elaborate:
“The project description must include a detailed account of your plans for cannabis cultivation and production. The purpose is to demonstrate that you will produce a consistent and standardised product of the required quality that can be included in the medicinal cannabis pilot programme. The project description must describe the safety measures you will take in connection with the cultivation and processing of cannabis. The project description must provide evidence that the production will result in cannabis that can be included in the medicinal cannabis pilot programme or possibly in the manufacture of medicinal products.” -Danish Medicines Agency "Development Scheme"
Cannabis Production Regulations in Denmark
Essentially, this project description needs to encompass a fully functional quality system that meets GACP and GMP standards. That means that before you get a license and start your cannabis business, you would do best to have a quality manager who can create such an elaborate system and ensure all requirements are met. Having a quality manager help you design your facility and ensure that the business structure and processes meet the regulatory statutes will save you a lot of time and money in the long run.
There is additional information about how to apply for a Danish cannabis license, but again, it is mainly published in Danish. This guide to project descriptions for applications does appear in English and can give you a better idea of what they are looking for.
“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.” -Danish Medicines Agency "Pilot Programme"
Danish Cannabis Cultivation Licensing Overview
- Complete application paperwork (Quality Manual/Quality Management System required)
- Get paperwork approval from the Danish Medicines Agency
- Get site approval from the Danish Agricultural Agency
- Get approval to produce from the Danish National Police
- Prove you can produce standardized cannabis by producing three test batches that have identical results
- Get an inspection from the Danish Medicines Agency to prove your practices and policies conform to regulations
Danish vs Canadian Cannabis Licensing
Essentially, the governments of Canada and Denmark ask for extremely similar requirements for cannabis production. Both want you to have a quality manual before licensure. Likewise, to achieve that in both cases you will benefit greatly from making your Quality Manager one of the first people you hire, or at a minimum, you will need a consultant such as GrowerIQ to act in that capacity. It is common for foreign investors with experience in stringent cannabis regulation to partner or invest in Dutch cannabis cultivation companies.
Like Canada, Denmark cannabis licenses have specific GACP and GMP-based requirements for staff, facilities, equipment, and record-keeping. Also, both Canada and Denmark have requirements regarding cannabis genetics, cultivation, harvesting, processing, packaging, and storage. Needless to say, GrowerIQ Seed-to-Sale Software is just as useful for Danish cannabis producers as it is for Canadian producers. Since GrowerIQ is based on both EU-GMP, GACP, and compliant with Canadian Cannabis Act regulations, it is highly adaptable to cannabis producers throughout North America and Europe.
The most apparent difference between Canadian cannabis licensing and Danish cannabis licensing is that Denmark’s program is exclusively for medical use and is a pilot program that is not finalized. The four-year Danish pilot program runs for a period of four years, starting from January 1, 2018. This means that the pilot program is nearing its end. If you are interested in growing cannabis in Denmark, you’ll want to reach out to their officials and discuss the future of their cannabis program in greater detail.
Maintaining a Cannabis Cultivation License in Denmark
After you get a Danish license to cultivate cannabis, you need to maintain it. This can be a challenge because you cannot make any changes to the “circumstances of the company.” If you want to change your processes, procedures, policies, or infrastructure after obtaining your cannabis cultivation license, you must get prior approval to do so from the Danish Medicines Agency. You must also comply with all laws on euphoriant substances and provide quarterly records to the Danish Medicines Agency.
Conditions for Revoking a Danish Cannabis License
- The pilot program is closed
- Cultivation activities are not in compliance with the project description that was approved
- Dutch laws on euphoriant substances are not followed
- License holder refuses to cooperate with authorities
Danish Cannabis Consumers
Like in Canada, Danish doctors determine what type of cannabis product is appropriate for the patient. Danish medical cannabis indications include:
- Painful spasms caused by multiple sclerosis
- Painful spasms caused by spinal cord damage
- Nausea after chemotherapy
- Neuropathic pain, i.e. pain due to a disease of the brain, spinal cord, or nerves.
There is a caveat to the listed indications that is unclear. It states that “Neither the law nor the pilot programme’s guidelines prevent doctors from prescribing medicinal cannabis to patients with other illnesses than those mentioned in the guidelines.” It thus seems that obtaining medical cannabis in Denmark is not too cumbersome of a process. If this is the case, then the program could be very popular and in high demand. This video explains how Denmark provides consumers access to medical cannabis in a system that is very similar to the one used in Canada.
Final Thoughts on Cannabis Cultivation Licenses in Denmark
When looking into the cannabis cultivation licensing and sales systems of Denmark, it is clear that they have very high standards for quality. They are treating cannabis much like a pharmaceutical product with production standards that are adjusted to suit a plant-based product. If you are interested in getting a medical cannabis cultivation license in Denmark, you should be prepared to meet this standard. You will greatly benefit from taking this approach and utilizing infrastructure like GrowerIQ’s Seed-to-Sale Software and consulting services. You may also want to consider your timing carefully as the current pilot program will expire soon. News is yet to come about how Denmark will proceed at this point, but it seems they are eager to be a leader in European cannabis production. However, it is likely that strict regulations will be maintained.
The fact that you found your way to this article is remarkable, we're sure that you're an ambitious grower. The oppourtunity in international trade does not end here. We have written guides on getting your cannabis license for more countries, such as Columbia, Thailand, Spain, and Australia. Check out our guides over here: Cannabis License in Colombia, Thailand: The First Asian Country to Legalize Cannabis, Cannabis License in Spain, and How to get your Medicinal Cannabis License in Australia.
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From initial consulting to business planning and intricate facility management, GrowerIQ can help you at any stage of your cannabis venture. We can empower your business to thrive in any cannabis market, compliant with regulations. If you're interested in kickstarting a licensed operation in Denmark, click the button to find out how GrowerIQ can fit your needs, or sign up using the form below to get in touch with our professional cannabis consultants. We'll help you devise a comprehensive plan for you to become a licensed producer.
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