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Legalization of CANNABIS, what are the conditions to obtain the LICENSE and how much area will be allowed to be planted

2023-06-17 10:02:09Fokus SHKRUAR NGA REDAKSIA VOX
Legalization of CANNABIS, what are the conditions to obtain the LICENSE and how
Edi Rama (Photo montage)

The government's draft law on the legalization of cannabis is cleared. In addition to the establishment of the National Agency for the control of cannabis, which will be subordinate to the Ministry of Health, the draft law also foresees the conditions for granting licenses and permits to interested entities.

Next to the National Agency for the Control of Cannabis, the Commission of Licenses will be established, which will administer and verify the requests that will be submitted by the subjects. This commission will also impose sanctions on those entities that are provided with permits and licenses but that violate the conditions or go beyond the defined legal framework. The license for each interested company is approved by the government based on certain criteria and selection procedures organized by the National Cannabis Agency. Thus, the total area allowed for the cultivation of the cannabis plant for medical purposes cannot be greater than 200 hectares at the national level.

Also, the license for cultivation activity is granted only in open, covered areas or greenhouses. The area of ​​the activity license unit for cultivation of cannabis for medical purposes cannot be less than 5 hectares and not more than 10 hectares. This restriction is expected to spark a fierce battle between companies to be licensed. The license for companies is granted for a period of 15 years.

The law sets strong criteria for obtaining a license. The first criterion is that the company must have 3 years of experience in the cultivation, production, processing, circulation and administration of the cannabis plant. The company or the shareholder with 51% of the company's shares must be engaged in the production of by-products of the cannabis plant in one of the 38 countries that are part of the Organization for Economic Cooperation and Development for at least 5 years.

The entity must be equipped with a certificate of good manufacturing agreement issued by the European Medicines Agency and the American Food and Drug Administration. Also, the company must have a capital not less than 100,000,000 ALL.

But to be equipped with a license, the subject, the administrator, the members of the governing bodies, the partners or the shareholders must not be under criminal prosecution or in trial for any criminal offense. In case of violations, there will be penalties ranging from a fine of 500,000 to 5,000,000 Lek, as well as a temporary ban on carrying out the activity for a period of 6 months to 3 years. The minister responsible for health decides to revoke the license if the entity repeatedly violates the conditions of the license.

Among the criteria to apply for a license is the self-declaration for the employment of at least 10 people for each unit, 2 of whom must be qualified employees in the field of pharmacy and agro-engineering, with work experience of no less than 3 years in the relevant field. The entities must make a self-declaration that after the third year they will pay an annual fee equal to 1.5% of the annual turnover, but in any case, not less than ALL 10,000,000. Also, the Entities must present a bank guarantee in the amount of 10% of the investment value, as well as present a self-declaration that they will meet all the requirements for traceability, according to the provisions of this law.

 


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