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19.03.2019

Navigating Changes in North Macedonia Cannabis Law, Policy and Licensing for 2019 and Beyond

Kiril Kolemisevski Managing Partner, Investment Mergers & Acquisitions, Banking & Finance

Trying to stay current on the latest developments on cannabis law, policy and licensing is always like chasing a moving target, and in the last several months, the law and regulations in this area has been very active. Speaking of change, the use of initiatives and referenda to bypass the previous traditional local government cannabis controls has become more and more common. One set of topics subject to significant tides of change are the newly proposed cannabis regulations issued by the Government of Republic of North Macedonia, which shall be endorsed as soon as the presidential elections are formally finished in mid-May, 2019.

These proposed changes mark the next step in the formal permitting to cultivate opium poppy, hemp and /or cannabis for medical and/or scientific purposes. Cannabis cultivation as well as production of seeds and planting material for cannabis shall be allowed to legal entities licensed by the Ministry of Health upon previous granted consent by the government. The law envisages the following criteria for licensing:

  •  provided adequate space, surfaces or land where cannabis will be grown indoors or outdoors;
  •  provided space for drying, cutting and storage, equipped pursuant to the processing capacity of the licensed entity, as presented in the production plan;
  • the cultivating land/surface, whether indoors or outdoors, must be protected with a fence at least four meters high and a barbed wire above the fence, providing 24 hour video surveillance over the entire space;
  • 24 hours of physical security surveillance;
  • has employed at least fifteen employees out of which at least one graduated pharmacist having at least three years work experience in the field of pharmacy and one employee - agronomist having at least three years work experience in the respective field.

An application for license shall be submitted to the Ministry of Health enclosed with the following supporting documents: 

  • company registration issued by the Central Register of North Macedonia;
  • proof of ownership of the land/surface or property deed or lease agreement;
  • proof of engaged physical security (personal or hired);
  • proof of engaged staff;
  • an elaborate/plan for cultivation of cannabis for medical and/or scientific purposes;
  • bank guarantee in the amount of 1 (one) million Euro in denar counter value.

The changes furthermore propose, the license issued under the law to have validity period no grater than five years from the date of obtaining government consent. The license may be renewed. The license shall be revoked if the entity does not start processing cannabis within six months from the date of obtaining government consent.

Another significant proposed change is that the dry mass (cannabis flower) extracted from the dried cannabis plant can be exported by the licensed cannabis cultivators. Тhe production, export and import of seeds, planted material, herbal raw material (cannabis flower), hemp oil, industrial hemp shall be permitted. The Macedonian Agency for drugs and medical devices, as well as the newly soon to be established Agency for Cannabis for Medical and Scientific Purposes of the Republic of North Macedonia shall be authorized for production, import and export licensing. These licenses are not transferrable. 

Furthermore, the foreign investors can perform these activities only through established companies/branch offices in North Macedonia pursuant to the provisions of the national Company Law. The amendments have also introduced an important change which permits transfer of shares only with prior government consent.  

In a nutshell, the following national institutions shall be involved in the process of licensing and supervision: Ministry of Health, Ministry of agriculture, forestry and water economy, Ministry of economy, Ministry of interior, Ministry of labor and social politics, Ministry of finance, Macedonian Agency for drugs and medical devices, the newly soon to be established Agency for Cannabis for Medical and Scientific Purposes of the Republic of North Macedonia and other relevant public and state institutions.

 At this time, the proposed cannabis law is filed in government process for addressing the newly proposed changes that will be considered during the final stages of the rulemaking process. Stay tuned to Kolemisevski & Partners Law Blog for more details on North Macedonia cannabis regulations.