Macedonia: Cannabis Cultivation and

Production of Hemp Extracts

Prepared by: Adil MEHMED

Preface
Cannabis cultivation for medical purposes is rapidly expanding and the cannabis market is exponentially growing
– it is expected to threefold its size in the next three years; hence, the interest for investing in this sector is
compelling. Having received requests from diaspora investors interested in investing in this sector in Macedonia
– as it is the only country in the region that has legalised cannabis cultivation and production of hemp extracts
for medical purposes – we prepared this brief with information on the Macedonian cannabis industry i.e.
cannabis cultivation and production of hemp products.1 The brief firstly presents the Cannabis Legalisation World
Map and then provides facts about cannabis in Macedonia. This is followed by an introduction of the Macedonian
companies in the cannabis sector, and a summary of the procedures for obtaining a Permit for cannabis
cultivation by the Ministry of Health (MH), and a Permit for production of hemp extracts. The document
concludes with presenting the legal provisions for cannabis cultivation in Macedonia.

Cannabis Legalisation World Map2

Argentina – Status: CBD legalised/Partially medically legalised/Decriminalised
Australia – Status: Medically legalised/Partially decriminalised

Canada – Status: Medically legalised//Full federal legalisation pending

Chile – Status: Medically legalised

Colombia – Status: Medically legalised/Decriminalised

Croatia – Status: Medically legalised

Czech Republic – Status: Medically legalised

Germany – Status: Medically legalised/Decriminalised

India – Status: Federally illegal, but legal in some states

Israel – Status: Medically legalised

Italy – Status: Medically legalised

Jamaica – Status: Partially medically legalised/Decriminalised

Macedonia – Status: Medically legalised

Mexico – Status: Medically legalised/Decriminalised

Philippines – Status: Medically legalised

Poland – Status: Partially medically legalised Turkey – Status: Medically legalised

United States – Status: medical use is legal in 31 states and the District of Columbia3.

Uruguay – Status: Legalised

1
For clarification purposes, the term cannabis refers to the plant, whereas the term hemp denotes all over-ground fresh
or dry parts of the plant.
2
http://www.cannabisbusinesstimes.com/article/cannabis-legalization-world-map/
3
http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

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Cannabis in Macedonia – Facts4
- Grown on 140 thousands sq. m area
- Of the six companies that have Permits from the MH for cannabis cultivation, only one produces cannabis
oil (NYSK Holding).
- World sales of medical cannabis are over $7B, and it is estimated that the market will increase its size
threefold in the next three years
- BIRN tried to get copies of the approvals for cannabis cultivation for medical purposes (through requests
for information of public character), but they got incomplete answers or they did not get any answers at
all
- Prime Minister Zoran Zaev called out “all investors who have resources to invest in this industry because
it is profitable”. He stated that the country expects a lot of newly-opened positions and €100M foreign
currency income

Existing Companies5
Companies that currently operate in the cannabis industry in Macedonia are the following:
o Replek Farm DOOEL, Skopje (May, 2016)6
 First producer of cannabis oil
 €400,000 investment
o NYSK Holding, Skopje (December, 2016)7
 NYSK has planted cannabis on 1,000 sq. m. where the plants are being grown indoor.
 The only company with a facility for cannabis oil extraction and is already producing bulk
final product oil.
 The whole investment, as estimated by Keskovski, is expected to be approximately
$5.5M
o MAM, Sveti Nikole (April, 2017)8
 MAM has planted cannabis on 20,000 sq. m in greenhouses
 The total investment is expected to exceed 10M EUR, and currently there are 30
employees from Sveti Nikole
 Trajce Zaev, the owner of MAM, said they have ongoing negotiations with foreign
investors for opening an oil-extraction capacity.
o Oaza Alkaloidi, Stip (August, 2017)9
 Owner: Slave Ivanovski
o Kaba Herbal, Skopje (August, 2017)10
o 5 Letters, Resen (September, 2017)11
 5,200 sq. m facilities for indoor cannabis cultivation

4
http://prizma.mk/makedonska-kanabis-revolutsija-vo-najava/
5 https://www.novamakedonija.com.mk/makedonija/hronika/%D0%BF%D1%80%D0%B5%D0%BC%D0%B8%D0%B5%D1%8
0%D0%BE%D1%82-%D0%BF%D0%BE%D1%82%D0%B2%D1%80%D0%B4%D0%B8-%D0%B4%D0%B5%D0%BA%D0%B0-
%D0%BD%D0%B5%D0%B3%D0%BE%D0%B2%D0%B8%D0%BE%D1%82-%D0%BF%D1%80%D0%B2-%D0%B1/
6
http://emagazin.mk/vesti/vest/22379
7
http://www.slvesnik.com.mk/Issues/e98cbb3c65e140648d51a1a108d6bad2.pdf
8
http://www.slvesnik.com.mk/Issues/2d30f673843b49159e15813163ffcc2a.pdf
9
http://www.slvesnik.com.mk/Issues/df612c2cedda4ebf9e85c5469d1ed1eb.pdf
10
http://www.slvesnik.com.mk/Issues/df612c2cedda4ebf9e85c5469d1ed1eb.pdf
11
http://www.slvesnik.com.mk/Issues/b5bcde690e394ba6b1af920f95ebefb7.pdf

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 o Medical 420, Bitola (December, 2017)12
o Farma Medica Cannabis, Valandovo (May, 2018)13
 Co-Founders: Katerina Bojovik Zaeva and Boban Zaev
 Boban Zaev has big plans about making an investment, which will allegedly open 500
new positions
 Slave Ivanovski’s (Oaza Alkaloidi) name appears amongst the owners
o F&M, Vrapciste, Gostivar (July, 2018)14

Licencing Procedures
a. Procedure for obtaining a Permit for cannabis cultivation. The legal entity interested in cannabis
cultivation prepares an elaborate and submits it to the MH. The MH then forms a Special Commission
(Commission) comprising of representatives from the MH, the Ministry of Agriculture, Forestry and
Water Economy (MAFWE), and the Agency for Medicines and Medical Devices (AMMD). Within 7 to 10
days upon receipt of the elaborate, the Commission conducts a field inspection and prepares an Opinion
Report (positive or negative) which is then forwarded to the Government of the Republic of Macedonia
(Government). If the Opinion Report is positive, the Government issues a Consent and forwards it to the
MH. The MH then grants a Permit for cannabis cultivation. Before commencement of cannabis
cultivation, the legal entity submits a Request for cannabis sowing/planting to the MAFWE which grants
a Permit for sowing/planting (depending whether seeds are sowed or seedlings are planted).
b. Procedure for obtaining a Permit for production of hemp extracts. On the other hand, the procedure
for obtaining a Permit for production of hemp extracts is much simpler: the legal entity submits a Permit
Request15 with supporting documents to the AMMD, which makes a decision upon reviewing the
Request. The supporting documents for obtaining the Permit are the following:
1. List of pharmaceutically-dosed forms that will be produced
2. Technically-Technological Elaborate – Extensive Site Master File
3. Documents (such as undergraduate degree in pharmacology, pharmacy competency exam, job
contract etc.) for the employees responsible for production, quality control and labelling of the hemp
extracts for trade
4. Proof of record of the legal entity in the Central Register of the Republic of Macedonia
5. Permit for usage of the facility where the production of hemp extracts will take place
6. Property list as proof of ownership of the facility, or facility lease agreement
7. Proof of paid administrative tax and other costs associated with obtaining a Permit for Production of
Hemp Extracts according to the bylaws on medicines.

Furthermore, depending on the type of production of hemp extracts, the producer needs to have the following
premises available:

1. Warehouse for receipt and storage of raw materials, with fulfilled quarantine requirements while
the quality control takes place
2. Warehouse for receipt and storage of packaging materials, with fulfilled quarantine requirements
while the quality control takes place

12
http://www.slvesnik.com.mk/Issues/5129020c4df94e0d9e7e0e698c353d84.pdf
13
http://vlada.mk/sednica/70
14
http://vlada.mk/taxonomy/term/5
15
https://malmed.gov.mk/wp-content/uploads/2.14-Pravilnik_za_obrazecot_na_baranjeto_i_potrebnata_dokumantacija-
_za_proizvodstvo_na_ekstrakti_od_konop-Sl_vesnik-br.90-od-2016.pdf

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 3. Space for production and packaging
4. Space for temporary storage of semi-products
5. Space for control of raw and packaging materials
6. Control lab
7. Warehouse for storage of products under declared keeping requirements, with fulfilled quarantine
requirements while the quality control takes place
8. Separate warehouse; secured warehouse for storage of:
I. Raw materials categorized in the group of opium drugs, psychotropic substances and
precursors of opium drugs
II. Medicines that contain opium drugs and psychotropic substances
III. Hazardous chemicals
IV. Raw materials and products that are not approved in the quality control procedure i.e.
recalled items
9. Shipping facility
10. Office
11. Wardrobe
12. Sanitary facilities
The cost associated with the procedure for obtaining a Permit production of hemp extracts is 1,000 EUR. The
deadline for granting a Permit for production of hemp extracts products is 90 days.

Legal Matters on Cannabis Cultivation

Eligibility criteria
In the section "Cultivation of hemp intended for the production of narcotic drugs" of the Law on control of opium
drugs and psychotropic substances, it is stipulated that cannabis cultivation is allowed for medical and/or
scientific purposes. The cultivation of cannabis is allowed only for legal entities that possess a Permit for cannabis
cultivation issued by the MH, upon prior Consent from the Government.

Required conditions
The legal entity is obliged to:
- Have adequate space, surfaces or land for cultivation, drying, and storage of cannabis, equipped
accordingly to the production; i.e. a processing capacity of the legal entity for cannabis cultivation;
o the space should be atmospherically protected and enclosed with at least 4-metre-high fence,
with brinov element in front of the fence in three rows of buckets and a barbed wire above the
fence;
- Have a 24-hour video surveillance over the whole space;
- Have a 24-hour presence of physical security;
- Have at least four employees of which at least one person is a graduated pharmacist with at least three
years of work experience in the field of pharmacy and at least one person is a graduated agronomist –
agriculture programme with at least three years working experience in the field.

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Procedure for obtaining a Permit for sowing cannabis
The legal entity that has a Permit for cannabis cultivation issued by the MH, before the commencement of
planting is obliged to submit a Request to the MAFWE for obtaining a Permit for sowing cannabis. The Request
shall be supplemented by the Permit for cannabis cultivation issued by the MH (certified photocopy by a notary);
a document for certified seed material; elaborate/plan for cultivation of hemp which contains information on
how the plant will be cultivated, quantity (number of seeds, seedlings, stems, wet and dry weight).
A Permit for sowing cannabis is issued by the MAFWE within 15 days from the day of receipt of the complete
Request. The legal entity, after receiving the Permit for sowing hemp from the MAFWE, is obliged to notify the
MH, the MAFWE, the AMMD, and the Commission before beginning the sowing/planting of the hemp seed. The
legal solution stipulates that during the period from sowing/planting to hemp harvest, the Commission will
conduct an inspection at least twice over the cannabis cultivation.

Records of cultivating, harvesting, and drying hemp

The cannabis cultivator is obliged to keep a record of the cultivated cannabis (sowing, seedling production,
transplanting, and number of stems). The cannabis cultivator is obliged to register and report all changes and
deviations in the cultivation of cannabis, which were previously planned in the elaborate, to the MH and the
MAFWE.
The cannabis cultivator is obliged, before commencing the harvest, to inform the MH about the day of
commencement of the hemp harvesting. After the completion of the hemp harvest, an inspection of the
harvested items is performed by the Commission for the purpose of determining the number of collected stems
and wet mass. The form, content and manner of keeping records for all stages of the cannabis cultivation shall
be prescribed by the MH.

"After a harvest, the collected plant/hemp is dried in a special purpose-built orderly space, sized depending on
the quantity of cultivated hemp located in the same location where the hemp is grown. The cannabis cultivator
must have the dried plant/hemp packaged in a cardboard box and sealed with a safety seal. Furthermore, the
cardboard box with the dried plant/hemp is obligatory marked with the following data: name and head office of
the legal entity (cultivator/producer), year of production, name of raw material, net and gross dry mass, form
(leaf, flower, plant, whole, chopped) and packaging date. The cannabis cultivator shall submit a Report to the
MAFWE and the AMMD for the completed process of cultivation and the total dry mass which was obtained", is
defined in Article 29-f of the respective legal solution.

Legal restrictions
In the respective legislation it is stipulated that the cannabis cultivated in the Republic of Macedonia can be
processed only in the Republic of Macedonia exclusively by a legal entity that has a Permit for production of
hemp extracts. The transfer of hemp to the processing site is carried out by the hemp producer accompanied by
representatives from the Ministry of Interior, at the expense of the producer.

Export-Import
A Permit from the AMMD must be obtained prior to the import of seeds and seedlings. According to the latest
amendments of the respective legislation, the legal entity is obliged to provide only a proof of origin of the
seeds/seedlings that are to be imported; a quality certificate of the seeds/seedlings is not mandatory.
Macedonian companies in the cannabis industry use both seeds and seedlings in their cultivation processes.
Replek Farm, for example, imports a middle product – dried cannabis flower from which it produces extracts.

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According to the existing legislation, only export of final products (extracts, granules, oil and similar) is permitted.
The companies that cultivate cannabis in Macedonia are not allowed to export the plant and therefore freeze
the flowers (fresh or dried). It is recommended that a prospective company finds placement for its plants or
builds an extraction facility before commencing cannabis cultivation. Furthermore, the final products can be
classified, and hence exported, as three types, depending on the THC content present in the product:

a) Food – below 0.001% THC;

b) 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);
c) Medicine – above 0.2% THC

The AMMD is the official body that grants a Permit for export of Border Line Products and Medicines. The export
duty amounts to 1,000 MKD, regardless of the quantity exported. In the case of Medicines, the procedure is more
complicated and requires greater control and documentation.