Medical Cannabis and Controlled Substances in North Macedonia – Legal and Regulatory Requirements

The Law on Control of Narcotic Drugs and Psychotropic Substances of the Republic of North Macedonia regulates the cultivation, production, possession, use, trade, import, export, transit and control of narcotic drugs, psychotropic substances and plants from which narcotic drugs may be obtained. The Law establishes a classification system under which controlled substances and plants are divided into four lists, depending on the level of control applicable to them. It also establishes specific requirements for production, trade, cannabis cultivation, import and export, record-keeping, reporting, storage, inspections and regulatory compliance. For businesses operating in the pharmaceutical, healthcare, research or cannabis sectors, understanding these requirements is essential for maintaining regulatory compliance in North Macedonia. This page is part of our practice in business and corporate law. 

How Are Narcotic Drugs and Psychotropic Substances Classified in North Macedonia?

Under the Law, narcotic drugs, psychotropic substances and plants from which narcotic drugs may be obtained are classified into four lists:

• List I — prohibited substances and plants;
• List II — substances and plants subject to strict control;
• List III — substances and plants subject to control; and
• List IV — precursors regulated under the applicable legislation on precursors.

The classification of a substance or plant determines the legal requirements applicable to its production, possession, trade, import, export and other regulated activities. For substances and plants classified in Lists II and III, as well as their preparations, the Law provides a regulated framework for production and trade. These activities may be carried out by legal entities that meet the applicable requirements for the production of medicines and hold the required permit.

Production and Trade of Controlled Substances

The production and placing on the market of controlled substances classified in Lists II and III, as well as their preparations, are subject to specific licensing requirements. A legal entity must satisfy the applicable requirements for the relevant activity and hold the required permit for the production and trade of controlled substances.

The Law also regulates the premises and equipment used for these activities. Production or trade involving controlled substances through unauthorized persons, or through premises and equipment that have not been specifically approved for such purposes, may constitute an offence. Businesses involved in controlled substances should therefore verify not only whether the activity itself is permitted, but also whether their licenses, premises, equipment and personnel satisfy all applicable regulatory requirements.

Cannabis Cultivation for Medical and Scientific Purposes in North Macedonia

The Law establishes a specific regulatory regime for cannabis cultivation for medical and/or scientific purposes. A legal entity intending to cultivate cannabis must obtain the required approval from the Ministry of Health and comply with statutory requirements concerning the cultivation process, premises, security, personnel and record-keeping.

Regulatory compliance continues after the approval is obtained. Before commencing sowing or planting, the cultivator must notify the competent authorities, while the cultivation process remains subject to ongoing inspection. Cannabis cultivators must also maintain records concerning the cultivation process, including information relating to sowing, seedling production, transplanting and the number of plants.

Obtaining the initial approval is therefore only one part of compliance. Companies engaged in medical or scientific cannabis cultivation in North Macedonia must continue to satisfy the applicable regulatory requirements throughout the entire cultivation and production process.

Import, Export and Transit of Controlled Substances

The import, export and transit of substances and plants classified in Lists II and III, as well as their preparations, may be carried out only through specially designated border crossings and on the basis of a permit issued by the Agency for Medicines and Medical Devices. Applications for import or export permits must contain information concerning:

• the importer and exporter;
• the relevant substance;
• the pharmaceutical form, where applicable;
• the quantity;
• the period of import or export;
• the method of transportation; and
• the border crossing through which the shipment will pass.

For exports, the application must also be accompanied by the import permit issued by the country of destination. Businesses involved in international trade in controlled substances should therefore ensure that all required permits and supporting documentation are obtained before the shipment takes place.

Record-Keeping and Reporting Obligations

Legal entities operating with controlled substances are subject to detailed record-keeping and reporting requirements. For substances and plants classified in Lists II and III, the Law requires records to be maintained and retained for at least five years. Depending on the activity, records may include information concerning:

• imports and exports;
• transportation;
• purchases and sales;
• other forms of disposal;
• quantities held in stock; and
• quantities produced, used or otherwise disposed of.

Legal entities must also submit periodic and annual reports to the Ministry of Health. Certain quarterly reports must be submitted no later than 20 days after the end of each quarter, while the annual report concerning the previous calendar year must be submitted no later than 1 March. In addition, legal entities holding substances or plants classified in Lists II and III must conduct an annual inventory and reconcile their actual stock with the relevant records.

Inspection and Regulatory Control

Compliance with the Law on Control of Narcotic Drugs and Psychotropic Substances is subject to inspection by the competent authorities. Inspectors may prohibit the production or trade of controlled substances where statutory requirements have not been fulfilled or where there is an immediate risk to human health or the environment. Inspectors may also order other measures and establish deadlines for bringing operations into compliance.

Following an inspection, the inspector must prepare a record of the findings. Where irregularities are identified, the inspector may issue a decision requiring specific corrective measures within a prescribed period. For certain irregularities, the Law provides for an education and corrective procedure, including an eight-day period for removing the identified irregularity. If the irregularity is not remedied, the competent authority may initiate a misdemeanor procedure.

Practical Checklist

Companies involved in controlled substances, pharmaceutical products or cannabis cultivation in North Macedonia should verify the following before commencing or continuing operations: (1) Classification — determine whether the relevant substance or plant falls within List I, II, III or IV and what activities are legally permitted for that classification. (2) Licensing — verify that the legal entity holds all required permits for production, trade, cultivation, import or export. Operating without the required permit is expressly identified as an offence. (3) Premises and equipment — confirm that the relevant premises and equipment satisfy the statutory requirements and have the necessary approvals. Using unauthorized premises or equipment may also constitute an offence. (4) Record-keeping — establish procedures for recording all relevant transactions, quantities and movements of controlled substances, and ensure records are retained for at least five years. (5) Reporting deadlines — calendar all quarterly (within 20 days of quarter end) and annual (by 1 March) reporting deadlines and ensure reports are submitted to the Ministry of Health on time. (6) Annual inventory — conduct the required annual inventory and reconcile physical stock with the relevant records. (7) Import and export — before any international shipment, verify that all required permits from the Agency for Medicines and Medical Devices have been obtained and that the shipment passes through an authorised border crossing. (8) Cannabis cultivation — where applicable, verify that all Ministry of Health approvals, pre-sowing notifications, cultivation records and inspection requirements have been satisfied. 

Frequently Asked Questions

Can a company freely trade in psychotropic substances in North Macedonia?

No. Trade in controlled substances is subject to specific statutory requirements and, for substances classified in Lists II and III, requires the relevant permit.

Does a general pharmaceutical license allow a company to trade in controlled substances?

Not necessarily. The Law requires legal entities dealing with substances classified in Lists II and III to meet the applicable requirements for pharmaceutical production and to hold the relevant permit for production and trade.

Can controlled substances be imported into North Macedonia?

Yes, where the applicable statutory conditions are satisfied. Import, export and transit of substances and plants classified in Lists II and III require a permit from the Agency for Medicines and Medical Devices and may be carried out only through specially designated border crossings.

How long must records concerning controlled substances be kept?

For records covered by the relevant provisions of the Law, the retention period is at least five years.

Are companies required to submit reports to the Ministry of Health?

Yes. The Law provides for periodic and annual reporting obligations concerning controlled substances, including information on quantities imported, exported, produced, acquired, supplied and held in stock. Quarterly reports are due within 20 days of each quarter end; the annual report is due by 1 March.

Is cannabis cultivation legal in North Macedonia?

The Law allows cannabis cultivation for medical and/or scientific purposes, subject to the prescribed approvals from the Ministry of Health and ongoing regulatory conditions throughout the cultivation process.

Can a company start cultivating cannabis immediately after obtaining approval?

No. Additional requirements apply before sowing or planting, including notification of the competent authorities. Compliance is ongoing — the cultivation process remains subject to inspection throughout.

What can happen if an inspection identifies non-compliance?

Depending on the nature of the irregularity, the competent inspector may order corrective measures, establish a deadline for compliance or prohibit production or trade. Failure to remedy certain irregularities within the prescribed period may result in a misdemeanor procedure.

What are the main compliance risks for companies dealing with controlled substances?

The main risks include: operating without the required permit; operating outside the scope of a permit; using unauthorized premises or equipment; failing to maintain records; failing to submit required reports on time; discrepancies between stock and records; and non-compliance with the specific requirements applicable to cultivation, import, export and handling of controlled substances. Several of these violations are expressly identified in the Law as offences.

Last updated: August 2026

Note: The above does not constitute legal advice and in no way can be accepted or understood as an instruction to act in a specific case. Each legal situation has its own characteristics that should be reviewed at separately, and for that reason we recommend that you contact a professional – a lawyer – for legal advice.