Licensing

PROCEDURE FOR OBTAINING A LICENSE FOR ACTIVITIES RELATED TO THE PRODUCTION OF CANNABIS FOR MEDICAL PURPOSES

A license for the production of cannabis for medical purposes may include the following activities:

1. a) Cultivation, production of cannabis plants for medical purposes
2. b) Transport of seeds, plants, and cannabis products and by-products for medical purposes within the territory of the Republic of Albania;
3. c) Export of cannabis plants, products, and by-products for medical purposes.

The license is granted for one or more activities, for a period of 15 years, with the right of renewal upon request, for each activity and based on the selection procedure organized by the Agency. The format of the license for activities related to cannabis production for medical purposes is approved by order of the Minister responsible for health.

The license is granted only to the entity that meets the conditions and criteria specified in this law, and only for the units and activities specified in its cultivation plan, specifying the coordinates of the unit’s location and the entity’s relationship with the land.

The license is granted only in the name of the entity and is non-transferable and irrevocable. The license includes the activities for which the entity is licensed, fulfilling the requirements specified in this law.

If the license specifies that certain activities, as stipulated in the license, may be performed entirely or partially by other entities, these entities shall be verified regarding the integrity requirement and explicitly specified in the license. Changes related to the transfer of ownership of these entities require prior written approval from the Licensing Commission. The Commission grants or denies preliminary approval within 3 months from the complete submission of the request, supported by documentation specified for verifying integrity.

The license specifies one or more units for which the entity has met the criteria. If the entity is licensed for more than one unit, they must be contiguous to each other and, in any case, not more than 4 units under the same license.

The cultivation activity license is granted only on open surfaces, covered or in greenhouses. The surface area of the licensed unit for cannabis cultivation for medical purposes shall not be less than 5 hectares and not more than 10 hectares.

The total permissible area for the cultivation of cannabis plants for medical purposes shall not exceed 200 hectares nationwide.

The applicant, to obtain a license, pays a fee of 100,000 (one hundred thousand) lek at the time of submitting the application, which is non-refundable. The procedure for paying the fee and the use of this fee is determined by joint guidance from the Minister responsible for finance and the Minister responsible for health.

The license terms, as specified in paragraph 2 of Article 15, must be adhered to by the licensed entity throughout its validity period. Every 3 years, the license terms are reassessed by the Agency, which, if it finds non-compliance with the conditions and criteria, proposes, as appropriate, the suspension or revocation of the license or requests the entity to fulfill the conditions within a 30-day period.

No later than 6 months before the expiration of the license validity period, the entity may request its renewal when it proves that it meets the licensing conditions according to the provisions of this law.