The Albanian government has finished drafting its law on medical cannabis

In accordance with the results of the referendum proposed by the Albanian prime minister, the’Albania has decided to begin producing medical cannabis within the country; for now, only for export.

And to say the least, Albania isn’t wasting any time. The law on medical cannabis and the requirements for obtaining licenses for cannabis production have already been drafted, four months after the referendum ended.

Following a public consultation, the bill will be submitted to Parliament.

The legislative initiative aims to regulate and oversee the cultivation, processing, and export of the cannabis plant and the production of its byproducts for medical and industrial purposes.

To implement the law, the National Agency for the Control and Monitoring of Cannabis Cultivation and Processing has been established and will report to the Ministry of Health. The agency is responsible for controlling and monitoring the process at all stages, from seeds, planting, and harvesting to drying and the final destination of the cannabis.

Each company’s license will be approved by the government based on certain selection criteria and procedures established by the National Cannabis Agency. The decision to grant a company a license to cultivate cannabis is proposed by the Minister of Health—in this case, Minister Ogerta Manastirliu.

Restriction: no more than 150 hectares

The law sets a limit on the maximum area of land that may be used to grow cannabis. Specifically, the total area authorized for the cultivation of the cannabis plant for medical purposes may not exceed 150 hectares nationwide.

In addition, the area of a license unit for medical purposes must be no less than 5 hectares and no more than 10 hectares. This restriction is expected to spark fierce competition among companies vying for licenses.

Requirements for Obtaining a License

The law sets strict criteria for obtaining a license. In practice, no Albanian company meets these requirements, since the first criterion is that the company must have experience in the cultivation, production, processing, distribution, and management of the cannabis plant.

The company or shareholder holding 51 % of the company’s shares must be engaged in the production of cannabis-derived products in one of the 38 countries that are members of the Organization for Economic Cooperation and Development. The entity must hold at least one GMP certificate issued by the European Medicines Agency and the U.S. Food and Drug Administration. In addition, the company must have a capital of at least 100,000,000 ALL (825,000 €).

Interested companies must also submit their business development plan, their cultivation model, and their cultivation objectives, as well as the minimum and maximum area of the cultivation facility. They must submit a plan for the preparation of facilities for drying, cutting, and storing cannabis.

The security plan for the cannabis cultivation and processing area, which outlines protective measures, fencing, camera surveillance, and 24-hour physical security.

Among the criteria for applying for a license are a self-declaration stating that the business employs at least fifteen people, a self-declaration of the intent to enter into agreements with the relevant agency of the ministry responsible for public order and security to ensure access for inspections, and a self-declaration that the business will begin operations within 12 months of obtaining the license.

Entities must also agree to pay, after the third year, an annual royalty equal to 1.5 % of annual revenue, but in any case, no less than 10,000,000 ALL (82,500 €).