Any company that plans to market or sell thje medical cannabis in the European Union must obtain an EU-GMP certification. In addition, local GMP certifications in the European Union (e.g., Denmark) may entail stricter requirements.
The requirements imposed on companies under the Danish licensing scheme depend on the activities the company will be allowed to perform. These requirements are designed to assure that only cannabis products of sufficiently high quality, purity, and pharmaceutical standards are dispensed for the treatment of patients.
The Danish Medicines Agency monitors whether the companies meet the requirements and follow their own procedures via spot and surprise visits by inspectors from the Agency.
The Danish Parliament has recently voted to make the programs permanent. As a result, the value of the Real Canna Seeds license has substantially increased.
Good Manufacturing Practice (GMP) ensures that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product.
To properly demonstrate our ability to meet the necessary GMP production standards and exceed their quality requirements, we must produce a minimum of four generations of carbon copy cannabis plants.
To gain the GMP certification, every generation produced must contain the exact same DNA and Cannabinoid profiles for each tested sample.
Prove the organization's management capabilities in product quality and safety assurance.
Enable employees to develop good production/operations habits.
Reduce safety risk in product quality and safety.
Timely detection of production and management problems with related cost reduction benefits.
Maintain close compliance with relevant laws and regulations.
Enhance the international credibility and public image of the organization.
Increase the customer's long-term confidence in the enterprise.
On the 23rd of June, 2021 Real Canna Seed was awarded a Development Scheme License by the Danish authorities.
This license permits us to grow cannabis plants for research and development purposes and to market and sell non-THC products, such as seeds.
Denmark is known to have one of the most stringent regimes in the world.
Full approval will mean Danish governmental approval for the growth of cannabis plants and sales of cannabis products containing THC. This will allow us to import and export cannabis for production and sale all over the world.
Initially, we will use this new mandate to focus on the medicinal-pharmaceutical market for cannabis products. Owing to the worldwide recognition of the strict Danish GMP and licensing scheme, we believe this market provide us with significant pricing power.
On January 1, 2018, the Danish government issued an executive order instituting a pilot program for the liberalization of cannabis for medicinal use in Denmark.
Under the new order, patients could be enrolled in the program to receive cannabis products for medicinal use in connection with various doctor- supervised treatments.
Additionally, the importation of legally-produced and certified medicinal cannabis and intermediate products was legalized.
To foster the local production of cannabis for medicinal use in mind, the executive order also established a licensing process to enable companies to engage in the cultivation of cannabis for research and development purposes (the “Development License”) to eventually produce cannabis for medicinal use in Denmark and for export to jurisdictions where the import of medicinal cannabis is legal.
The GMP schema covers all aspects of production, from the starting materials, premises, and equipment to the staff’s training and personal hygiene practices. Detailed, written procedures are required for each process that could affect the quality of the finished product.
Strict procedures to continuously document compliance with correct procedures are required at each step in the manufacturing process. Good Manufacturing Practice guidelines provide manufacturing, testing, and quality assurance specifications to ensure that a food or drug product is safe for human consumption.