How do you get a cannabis cultivation license in Macedonia?
Medical cannabis cultivation in North Macedonia was legalized in 2016. You must have a license to cultivate cannabis in Macedonia, recreation use and cultivation is still prohibited and heavily criminalized.
The North Macedonia Health Ministry’s publication of its cannabis laws is difficult to digest. First, you need to translate the page from Macedonian to English using a browser extension. Second, the web page for the regulations looks like a cheap website page and is dated December 22, 2015. This all makes it very suspect when it comes to the accuracy of the information. Once you dig in, you’ll notice that the regulations have some very poor legal definitions that conflate hemp and cannabis. There’s really no way to tell if this is due to a poor translation, or poorly written regulations.
Aside from this old website page, the only information about cannabis cultivation licensing in Macedonia comes from blog and news websites. The reader should be aware that in the case of cannabis cultivation in Macedonia, the information we present here does not have the same level of confidence as it does in most of our reporting.
Cannabis License Regulations in Macedonia
Defining Cannabis in Macedonia
Article 1 of the Law on Control of Narcotic Drugs and Psychotropic Substances sets out the following definitions (grammar and punctuation has been corrected):
"Hemp" are all aboveground fresh or dry parts of the plant, except the seeds of different cannabis plant species (cannabis sativa, cannabis indica and cannabis ruderalis).
"Hemp seed oil" is a fatty oil, whether or not refined, obtained by cold pressing or other extraction from seeds of plants belonging to different species of the genus Cannabis and not containing more than 10 mg/kg of tetrahydrocannabinol (THC). Its primary application is in cosmetics and hygiene products, lubricants, dyes or as food.
"Cannabis oil / hemp oil" is a liquid resinous extract obtained by extracting oleoresin from aboveground parts (excluding seeds) of plants belonging to different species of the genus Cannabis and has a high content of cannabinoid components, especially tetrahydrocannabinol (THC). "
Since Macedonia is defining all dried flower as “hemp” there is already a major issue since marijuana and hemp are quite different and have different medical (and recreational) properties. Sarah Friedman for CBD Testers (July 3, 2020) reports that CBD oils with less than 0.2% THC can be sold without a prescription in North Macedonia. To get a prescription for medical cannabis you would have to see a radiologist, oncologist, neurologist, or infectious disease specialist. But if CBD which comes from hemp is regulated differently than medical marijuana, why are they defined the same? Perhaps it is a translation or interpretation issue, but it is truly ambiguous if these regulations are applied to all cannabis, just medical marijuana, or if they are intended for actual hemp. Other blog and news articles do corroborate that hemp and medical marijuana are treated differently.
Laws for Getting a Cannabis License in Macedonia
Article 29 requires growers to keep detailed records of cultivation and report any deviation to the Ministry of Health and the Ministry of Agriculture, Forestry and Water Economy.
Article 29-a requires legal entities to obtain consent from the Government of the Republic of Macedonia and have a “hemp” cultivation permit issued by the Ministry of Health. Again, the term hemp is used but the law is intended for medical marijuana.
Article 29-b sets out specific requirements for cultivation facilities:
- Land for cultivation must have adequate space for growing, drying, and storage
- It must be “equipped in accordance with the production, ie processing capacity of the legal entity for hemp cultivation”
- Land must be protected with a fence that is at least 4-meters high
- There must be 24-hour video surveillance over the whole space
- There must also be 24-hour physical security
- The entity must employ at least four people
- At least one employee must be a B.Sc. pharmacist with at least three years of work experience in the field of pharmacy
- At least one employee must be an agronomist with at least three years of work experience (this may also require them to have worked with the agriculture department)
Article 29-b also details the application requirements for getting approval for “hemp” cultivation. Again, the word hemp is used but this regulation seems to be applied to medical cannabis. Cultivation applications do not appear to be available anywhere online, but according to the law, they require the following information:
- Name of legal entity
- Proof of legal entity registration with the Central Register of the Republic of Macedonia
- Location of the cultivation site
- Proof of ownership or lease agreement for the cultivation site
- Name, contact information, and credentials of the person or persons responsible for obtaining “hemp” cultivation approval
- Proof that administrative fees have been paid
- All of this information must be submitted after being certified by a notary public
Supposedly, approval is granted from the Ministry of Health within 30 days of obtaining consent from the Government of the Republic of Macedonia. The Minister of Health, along with the Ministry of Agriculture, Forestry and Water Economy, the Agency for Medicines and Medicinal Products, and a specialist in the field of medicinal plants will all evaluate the cultivation space and equipment to ensure it meets requirements.
The law indicates that the Minister of Health also prescribes additional (unpublished) detailed requirements for the space, equipment, staff, the manner of providing and storing the space where hemp is grown.
Kiril Kolemisevski (January 1, 2019) and Health Europa (July 7, 2020) both report that these requirements are specifically for GACP and EU-GMP to be met. They both indicate that cannabis cultivation facilities in Macedonia must be GMP certified under EU-GMP regulations.
Kolemisevski also explains that after getting approval to cultivate cannabis in Macedonia from the Health Ministry, a separate authorization to begin planting needs to be obtained from the Ministry of Agriculture, Forestry and Water Economy (Article 29-c). He also clarifies that a manufacturing authorization by the Agency for Medicinal Products and Medical Devices is a third and separate requirement. This third authorization is where strict EU-GMP requirements are enacted.
Article 29-c requires license applicants to submit a request to begin growing from the Ministry of Agriculture, Forestry and Water Economy. This request needs to contain the following information:
- “Hemp” cultivation approval issued by the Ministry of Health (notarized photocopy)
- Seed certification documents
- A cultivation plan with “elaborate” information such as cultivation method and quantities of seeds, seedlings, stems, and wet and dry yield weights
Article 29-e requires growers to notify the Ministry of Health of the day cultivation begins and also when harvest will begin. There will be an inspection by the agency to ensure records corroborate with the actual harvested material.
Article 29-e requires that “hemp” grown in Macedonia to be processed only in Macedonia. Health Europa (July 7, 2020) explains that North Macedonia prohibits the export of dried cannabis flower and has a very small domestic market. Bulk cannabis oil and finished products can qualify for export, but companies must get additional certifications and invest more in meeting EU regulations.
Article 29-f requires harvested cannabis to be dried and stored in a specified location at the cultivation site. The grower is required to pack dried cannabis in a cardboard box and seal it with tamper-evident tape. The box must be labeled with specific identifying data and cultivation information. After that, the grower submits a report of their total yield in dry mass.
Improvements to Macedonian Cannabis Law
Health Europa (July 7, 2020) reports that The Association of Medical Cannabis Cultivators in North Macedonia (MAKKANABIS) is working to propose amendments that would establish a separate law and regulatory body for the cannabis industry. They are also proposing legislative changes to allow the export of dry cannabis flower and permit the use of the whole plant for industrial applications. MAKKANABIS does not have any information detailing this on their website, however. It is not clear what role this association is playing in the Macedonia cannabis market.
Should You Consider Cultivating Cannabis in Macedonia?
Sarah Friedman for CBD Testers (July 3, 2020) reports that getting your cannabis cultivation license in Macedonia is not cheap or fast. Some estimate that growers will need to invest up to $1 million before even paying for the license and becoming a registered entity.
Karanovic & Partners for Lexology report that over 30 companies are currently licensed to grow cannabis in Macedonia. That being said, it does not seem like the best place to invest in cannabis cultivation. The country is not likely to adopt a recreational market, and clearly has a lot of work to do to make its medical cannabis market accessible to international investors and cultivation companies.
That said, if you are interested in getting a cannabis cultivation license in Macedonia, GrowerIQ has the EU-GMP expertise you’ll need to have a compliant cultivation business. The GrowerIQ Seed-to-Sale Software is designed specifically to meet such regulatory requirements. It tracks your genetic materials and cultivation weights, keeps records and creates reports, and supports GACP and GMP standard operating procedures.
Find Out More
From initial consulting to business planning and intricate facility management, GrowerIQ can help you at any stage of your cannabis venture. We can empower your business to thrive in any cannabis market, compliant with regulations. If you're interested in kickstarting a licensed operation in Macedonia, click the button to find out how GrowerIQ can fit your needs, or sign up using the form below to get in touch with our professional cannabis consultants. We'll help you devise a comprehensive plan for you to become a licensed producer.
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