Medical Cannabis Operations in Ukraine: Complete List of Licenses and Permits
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On June 11, 2026, medicines based on medical cannabis were dispensed by electronic prescription in Ukraine for the first time. This marked the practical start of the implementation of medical cannabis legislation and the opening of a new segment of the pharmaceutical market.
At present, medical cannabis based medicines are already available at 36 municipal and 30 private pharmacies. In addition, approximately 180 more pharmacy outlets are registered in the system of the State Service of Ukraine on Medicines and Drugs Control and may join the distribution of these medicines once certain regulatory requirements are finally settled. This indicates a gradual expansion of the network of facilities that will work with medical cannabis based medicines.
At the same time, the production, import, storage, and distribution of such medicines fall within the sphere of controlled substance circulation and are subject to special licensing and state control requirements. This article examines which permits are required to operate in the medical cannabis market, what requirements apply to pharmacies and healthcare facilities, and what legal risks businesses should consider.
What Licenses and Permits Are Required for the Production and Handling of Medical Cannabis?
The regulatory framework for medical cannabis in Ukraine covers the entire supply chain, from the cultivation or import of cannabis plant substance, which is used as an active pharmaceutical ingredient (API), to the distribution of finished medicinal products to the end patient.
Following the adoption of Law of Ukraine No. 3528 IX, Draft Law No. 7457, and the amendments introduced by Resolution of the Cabinet of Ministers of Ukraine No. 1025 dated September 30, 2024, which updated the licensing conditions for the handling of narcotic drugs, regulation of the medical cannabis market has become significantly more detailed. The legislation effectively distinguishes between requirements depending on the source of the raw material, whether it is imported or cultivated in Ukraine.
Broadly, the structure of the medical cannabis market can be represented as follows:
Cultivation/import of cannabis substance → medicinal product manufacturing → distribution → dispensing by pharmacies under an electronic prescription
At each stage, the legislation establishes separate permit, licensing, record-keeping, and control requirements. Therefore, a single business entity may need several licenses simultaneously, depending on its chosen business model.
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License for the Handling of Narcotic Drugs, Psychotropic Substances, and Precursors
This is the basic license for all participants in the medical cannabis market in Ukraine. Pursuant to Article 8 of Law of Ukraine No. 60/95 VR, the State Service of Ukraine on Medicines and Drugs Control issues a license for the handling of narcotic drugs, psychotropic substances, and precursors for specific types of activities:
- acquisition;
- storage;
- transportation;
- sale (dispensing);
- use;
- destruction of controlled substances.
For entities engaged in the cultivation of medical cannabis, this license includes a separate type of activity, namely the cultivation of plants of the genus Cannabis. The cultivation of medical cannabis is permitted exclusively:
- in enclosed growing facilities;
- with 24-hour video surveillance;
- with law enforcement authorities having permanent and free access to the monitoring systems.
All these requirements are regulated by the Licensing Conditions established by Resolution No. 282 of the Cabinet of Ministers of Ukraine.
License for the Industrial Manufacture of Medicinal Products
This license is required for enterprises that carry out cannabinoid extraction, processing of plant-based raw materials, and serial production of finished medicinal products. The main requirements include:
- compliance with GMP standards;
- qualified personnel;
- a quality control system;
- appropriate material and technical facilities;
- internal procedures for controlling the handling of controlled substances.
Import Licenses
Since the Ukrainian medical cannabis market initially relies primarily on imported raw materials, imports are of critical importance. Here, it is necessary to legally distinguish between two different regulatory mechanisms.
Import of API (substance) requires:
- a license for the handling of narcotic drugs, with import as the relevant type of activity;
- a separate permit from the State Service of Ukraine on Medicines and Drugs Control for each shipment;
- permits for transportation and storage.
Import of finished medicinal products requires:
- a license for the import of medicinal products;
- a permit for the import of controlled substances.
The imported cannabis substance must be entered in the State Register of Medicinal Products of Ukraine as an API.
Please note: APIs and finished cannabis based medicinal products are regulated under different licensing mechanisms.
License for Retail Sale and Compounding in Pharmacies
A pharmacy that dispenses medical cannabis based medicines must have:
- a license for the retail sale of medicinal products (the Licensing Conditions established by Resolution No. 929 of the Cabinet of Ministers of Ukraine);
- a license for the handling of narcotic drugs;
- in the case of extemporaneous compounding, a permit to compound medicinal products in pharmacy conditions.
Only registered cannabis based APIs may be used. Medicinal products may be dispensed exclusively by electronic prescription, with the relevant transaction, such as dispensing, recorded in the ESORMC, the electronic system for recording the circulation of medical cannabis.
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Requirements for Pharmacies and Healthcare Facilities Engaged in the Production and Handling of Medical Cannabis Based Medicinal Products
One of the key features of the medical cannabis market is full traceability of product movement. The specific requirements include:
- National Police authorization. Mandatory for premises where controlled substances are stored or handled.
- Security and video surveillance. Facilities must be under 24-hour security and continuous video monitoring.
- State quotas. Annual quotas determine the volumes of production, import, storage.
- Electronic record-keeping in ESORMC. Each plant, batch of raw materials, and finished product is assigned a unique electronic identifier in accordance with Resolution No. 857 of the Cabinet of Ministers of Ukraine, ensuring transparency and traceability of the controlled plant.
All transactions, including movement, processing, and sale, must be recorded in ESORMC no later than the next business day.
Obligations of Pharmacies and Healthcare Facilities in the Handling of Medical Cannabis
|
Criterion |
Pharmacies |
Healthcare Facilities |
|---|---|---|
|
Personnel control |
Appointment of an authorized person |
Identification of physicians authorized to prescribe treatment |
|
Procurement |
Only from licensed suppliers |
Only from licensed suppliers |
|
Record keeping |
ESORMC + electronic prescription processing |
EHS for prescribing treatment and maintaining medical records + ESORMC for recording the receipt, use, write-off, and remaining stock of medical cannabis based medicinal products, if the healthcare facility uses finished medicinal products or medicinal products compounded in a pharmacy as part of its medical practice |
|
Storage |
Safes and designated premises |
Designated storage areas |
The full cycle of medical cannabis control includes:
- prescribing treatment through the EHS;
- checking the QR code/barcode;
- entering the data into ESORMC;
- processing the electronic prescription upon dispensing.
Any handling of cannabis outside medical, industrial, or scientific purposes remains subject to criminal liability.
Legal Support for Activities in the Medical Cannabis Sector
The launch of the medical cannabis market opens new opportunities for pharmaceutical companies, pharmacy chains, healthcare facilities, and investors. At the same time, this sector remains one of the most heavily regulated in Ukraine, and obtaining permits for medical cannabis requires an in-depth understanding of the applicable legislation.
You do not have to navigate complex legislation and bureaucracy on your own. We provide our clients with both comprehensive consultations and full legal support for medical cannabis licensing:
- conducting a legal audit of activities;
- determining the required licenses and permits;
- assisting with obtaining medical cannabis licenses;
- preparing documents for regulatory authorities;
- ensuring full compliance of activities with legal requirements.
The emergence of the first patients who have already received treatment with medical cannabis based medicines confirms the actual launch of the new market in Ukraine. Therefore, companies planning to establish a position in this segment should take care in advance to obtain the appropriate medical cannabis licenses and legal support.
Book a consultation with our specialized lawyers to discuss your business model in detail, estimate the timeframe for obtaining the required permits, and prepare your company for a successful launch in Ukraine's new pharmaceutical market.
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