Pharmaceuticals and Medical Devices

Key Figures

Cannabis Cultivation and Production of Hemp Extracts in Republic of North Macedonia

North Macedonia is one of the few countries in the world with the legal right to grow and export medical cannabis
North Macedonia legalized the growth of marijuana for medicinal purposes on February 9, 2016
The system for medical cannabis in North Macedonia is different from most countries in Europe because the country has adopted the Canadian open model of cannabis-based products, rather than setting up production under a state monopoly
This has led industry sources to be optimistic that North Macedonia can be a leader in this area, as development by private companies rather than a state monopoly will encourage those in the sector to offer innovative products and price them competitively
The aim to become the leading exporter of medicinal cannabis products in Europe drives cannabis production in the Republic of North Macedonia.

Sector Overview

The Republic of North Macedonia is one of the few places in the world that allows for the cultivation and exportation of medical cannabis. North Macedonia legalized the growth of marijuana for medicinal purposes on February 9, 2016. This makes North Macedonia one of the few countries in the world that allow for the cultivation and export of the plant – opening its doors to entrepreneurs and investors. The Macedonian pharmaceutical market is currently valued at over €145.6m per annum and North Macedonia imports over 50% of its medical products.

Advantages

Our country has decided to take a free-market approach to cannabis cultivation, distribution, and sale, mirroring Canada’s approach to these – allowing for private companies to cultivate and distribute the plant in North Macedonia. Our approach to cannabis cultivation offers numerous advantages in terms of medicinal cannabis innovation and product pricing, placing the Republic of North Macedonia in the central position in the cannabis industry within the region and a unique place in the European cannabis market.

Permits and procedures

Permit for cannabis cultivation

The legal entity shall be obliged to meet the following conditions:

To have provided adequate premises, areas, or land for cultivating, drying, and storing, equipped adequately for the manufacturing, that is, processing capacity of the legal entity for the cultivation of cannabis,
The space to be atmospherically protected with a fence of at least four meters in height, with razor wire in front of the fence coiled in three rows and barb wire above the fence,
To have provided 24 hours video surveillance over the entire space,
To have 24-hour physical security,
To have employed at least four persons of whom at least one person be a graduate pharmacist with a work experience of at least three years in the field of pharmacy and one agronomist – department of field crop production with a work experience of at least three years in the area.

The application for obtaining approval for the cultivation of cannabis shall be submitted to the Ministry of Health.

Procedure for sowing/planting cannabis

The legal entity that has approval for cannabis cultivation, before starting the sowing/planting, shall be obliged to apply to the Ministry of Agriculture, Forestry, and Water Economy to obtain approval for the sowing/planting of cannabis.

The legal entity, after the obtaining the approval for cannabis sowing/planting (hereinafter referred to as cannabis cultivator), shall be obliged, before the start of the sowing/planting of the cannabis seeds, to inform the Ministry of Health, the Ministry of Agriculture, Forestry and Water Economy, the Agency for Medicinal Products and Medical Devices.

Procedure for harvesting and drying hemp

The cannabis cultivator shall submit a report to the Ministry of Health, the Ministry of Agriculture, Forestry and Water Economy, and the Agency for Medicinal Products and Medical Devices about the completed process of cultivation and the obtained total dry weight, within three days as of the day of the completed process of cultivation.

Permit for production of hemp extracts

The legal entity submits a Permit Request with supporting documents to the AMMD (Agency for Medicines and Medical Devices), which decides upon reviewing the Request.

Export-Import

According to the existing legislation, only the export of final products (extracts, granules, oil, and similar) is permitted. The companies that cultivate cannabis in North Macedonia are not allowed to export the plant and therefore freeze the flowers (fresh or dried).

The final products can be classified, and hence exported, as three types, depending on the THC content present in the product:

Food – below 0.001% THC;
Border Line Product – between 0.001% and 0.2% THC (also products from cannabis that are low in THC but contain other cannabinoids, such as CBD, belong in this group);
Medicine – above 0.2% THC

The AMMD is the official body that grants a Permit for the export of Border Line Products and Medicines.

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