Medicinal Cannabis in Macedonia (The Republic of North Macedonia)

Medicinal Cannabis in Macedonia, recently formally renamed the Republic of North Macedonia, is booming.  Cannabis business development in the region resembles similar trends we’re noticing in the global medicinal cannabis industry across the globeSee “Predictions for global medicinal cannabis industry growth (2020-2024)” and continue reading for information about cannabis business sectors in Macedonia/North Macedonia.

There is definitely a noticeable increase in public acceptance in the use of medicinal cannabis medications to treat conditions that are unresponsive to more conventional treatments and drugs. There are also a number of newly registered doctors and GPs with authorization for prescribing medicinal cannabis products to their patients.

Experts predict the market is likely to continue expanding rapidly, similar to cannabis development trends in North Macedonia, particularly as Australia develops medicinal cannabis production. The aims are for meeting the needs for domestic use as well as international cannabis demand through exportation of medicinal cannabis including seeds, medicines, oils and cannabinoid-derived ointments.

The cannabis industry development we are seeing in Australia as well as in the Republic of North Macedonia is not dissimilar to what we’re noticing is occurring in Thailand.  Stay up to date by visiting our medicinal cannabis industry news, media releases and research articles.  Or contact us to get a copy of our latest article “Could you, would you, should you… engage in Thailand’s Medicinal Cannabis Industry?” (publishing soon).

Cultivation, Production &  Exportation of Medicinal Cannabis | Macedonia

What makes a country successful for timely, cost-effective cannabis production? How do Governments support medicinal cannabis research studies when such sparse evidence-bases exist?

The answer to how Governments support industry development relates to (1) cannabis research funding investments and (2) licencing, importation and exportation legality changes; while sustaining good manufacturing practices including sterility and safety standards.

Europe Industry News: Macedonia Cannabis Production

The Republic of North Macedonia is another emerging country in the burgeoning cannabis industry.  It is one of the few countries in Europe where cannabis cultivation and production, including export of medicinal cannabis products, has been legalized. The lack of state monopoly in terms of cultivation, distribution and sale of cannabis allows companies that operate in the industry to freely distribute their products within their country.

This approach is rare amongst most countries legalising medicinal cannabis, most who have maintained highly restrictive regulations on licencing and exportation.

  • The other issue for most countries seeking to capitalize on cannabis industry growth rates, is that Federal and State law often conflict
  • Policies remain under consideration and/or in development, which stalls both progression and innovation in developing proven, standardised cannabis crop cultivation methods and sustainable seed sources
  • Current constraints also delay the provision of Australian-grown cuttings and research supplies; creating confusion and construction delays for would-be producers, investors, researchers and patients

The lack of national legislation results in lengthy licencing application approval processes and interstate collaboration difficulties. This can further delay the development of Australian-grown cannabis seeds and plant cutting supplies.  The longer the delay, the more Australia will have to rely on expensive imports.

Essentially, start-up cannabis businesses are losing ground to countries like Macedonia, already ahead in their plant and seed supplies to help meet national and global demand.

What makes Macedonia unique

This 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 in a unique place in the European cannabis market.

The aim to become the leading exporter of medicinal cannabis products in Europe drives the cannabis production in the Republic of North Macedonia.

  • Not surprisingly, since the legalization in February 2016, the cannabis industry in the Republic of North Macedonia has increased to a value of over USD $230 million (~€ 145mil) per annum.
  • This figure is expected to triple within the next 3 years.
  • A record increase of investment by local and international companies from Germany, Israel, USA, Turkey, Thailand and Australia has also been recorded.

Find our Public Training Courses and Cannabis Masterclass and GMP Training Dates or register your interest in the training academy.

You can also read more about predictions for the medicinal cannabis industry (global market predictions).

Companies Licenced for Medicinal Cannabis in Macedonia

The Republic of North Macedonia, at present, also imports nearly 50% of the medicinal cannabis in the form of dry flower or extracts. This might soon change, as there are already 15 companies in Macedonia that have licences and expertise to cultivate and produce medicinal cannabis.

Licensing Requirements for Cannabis Cultivation and Production

Although barriers to cultivation and exportation are reduced when a national regulation exists versus state-specific legislation; Macedonia isn’t a ‘free for all’ country when it comes to medicinal cannabis production.

Recreational use remains illegal in Macedonia; and gaining licence approvals still requires meeting strict criteria and good manufacturing practices (GMP).

To obtain a licence for cannabis cultivation and production in the Republic of North Macedonia, the legal entity must satisfy a number of legal requirements including:

  • a registered office in the country that will be a primary contact with the national regulatory authorities
  • adequate land and space for performing the planned activities
  • physical security
  • 24 hours video surveillance and
  • to have at least four employees
    • one of which must be a pharmacist and
    • one a graduate agronomist with a minimum of three (3) years of work experience within the industry

The legal entity must also obtain a permit from the Ministry of Agriculture, Forestry and Water Economy (MAFWE) for sowing/planting cannabis.

To produce medicinal cannabis products, the legal entity must demonstrate:

  • compliance with the GMP regulations for the manufacture of medicinal products and
  • have a licence for manufacturing and product marketing

Cannabis Licencing Processes and Timeframes

To obtain a licence for cultivation and production of medicinal cannabis products currently may take up to 6 months.

A permit must also be obtained to import or export medicinal cannabis, with cultivation companies in Republic of North Macedonia importing both seeds and plants. Some companies licensed to produce and market products (e.g. Replek Farm) also import dry cannabis flower for production of extracts.

Recreational vs Medicinal Cannabis use in the Republic of North Macedonia

Brief overview of recreational cannabis use laws and restrictions in this region (current as of June 2019):

  • Use of cannabis recreational purposes in Republic of North Macedonia is still illegal.
  • Possession of dry cannabis flower may infer a fine and possible imprisonment.
  • Patients may access medical cannabis products only if they have an authorised Doctors’ medical prescription.
  • Cannabis oil though containing equal or less than 0.2% THC can be bought as over-the-counter medicine in selected pharmacies.

Europe based Cannabis Research Trials for Medicinal Property and Safety Investigations

In addition to expanding on the Republic of North Macedonia’s capacity for production of cannabis, the country has also set up centers for world-class clinical cannabis research to further investigate the medicinal properties, safety and efficacy of cannabis based treatments for various medical conditions.

What sets this country apart in the global market for medicinal cannabis

Its central geographical location within the region, its favorable climate and agriculture conditions as well as the availability of expertise for cannabis cultivation, has added to the number of advantages that place the Republic of North Macedonia as a leader in the cannabis industry within this region and beyond.

Due to recent changes of political landscape of the Republic of North Macedonia, the country has now received wide acceptance in Europe and it is lined up for acceptance in NATO and EU.

Collaboration with countries emerging within the cannabis industry such as Republic of North Macedonia, could open more doors to explore and create new opportunities for expansion into new horizons of the cannabis market and ensure availability and access of patients to much needed medicinal cannabis products.

If you would like to know more about the design and compliance requirements talk to our medicinal cannabis consultants, cultivation experts, architects, engineers and compliance experts in one company. Or if you looking to be trained PharmOut offers a range of GMP, GACP, and cultivation and cannabis business courses specific to Medicinal Cannabis. Or visit our top 5 facility design tips,