Effective 16 August 2024,
Ukraine's Medical Cannabis Law enhances patient access to medical cannabis for specific conditions and regulates its use for medical, educational, and research purposes. This legislation also creates investment opportunities and simplifies industrial hemp cultivation, though recreational cannabis remains illegal.
Streamlined Industrial Hemp CultivationThe law introduces streamlined procedures for cultivating industrial hemp (agricultural plants listed in
List No. 3, Schedule 1). Businesses must be included in the Industrial Hemp Register maintained by the Ministry of Agrarian Policy and Food of Ukraine. Once registered, no additional licenses are needed, and cultivation is allowed on a declarative basis starting from 16 August 2024.
THC content in the crop must remain below 0.2% until mid-February 2027, and below 0.3% thereafter. Harvesting is only allowed after the crop has passed laboratory tests confirming compliance with these THC limits. Any crop exceeding these thresholds must be destroyed and cannot be utilized for any purpose.
Industrial hemp has significant potential for applications in food, building materials, wellness products, apparel, etc. CBD isolate is not currently classified as a controlled substance. New regulations may simplify the sale of CBD products, such as oils, cosmetics, and veterinary products, in Ukraine.
Medical Cannabis CultivationConversely, the cultivation of medical cannabis (medicinal plants listed in
List No. 4 of Schedule 1) is restricted to medical, educational, and research purposes, and for the production of medicinal products and export. The THC content must be at least 0.3% in dried straw. Determining THC threshold is done through laboratory testing by specialized enterprises or expert institutions. Only legal entities can engage in cultivation.
Cultivation is tightly regulated through government quotas and requires licensing at every stage. Cannabis must be grown indoors under strict government standards, with rigorous tracking systems including certified second-generation seeds or higher, sourced according to
Resolution No. 776, plant labeling, and electronic registration. Additionally, round-the-clock security video surveillance and security are mandatory throughout all stages of cultivation, storage, and processing. Harvesting is permitted only after the crop has passed laboratory tests confirming THC compliance.
How to Apply for a LicenseTo operate with medical cannabis, specific licensing requirements must be met. The process involves obtaining a license from the State Service of Ukraine for Medicines and Drug Control (SMDC).
This includes completing the SMDC’s application form and providing necessary documentation such as the manager’s qualifications and passport, a certificate confirming employees' clean criminal records, and a medical certificate indicating no mental disorders or substance abuse issues.
Additionally, a permit from the National Police is needed to use facilities designated for the storage and processing of medical hemp and cannabis-based products. This permit application should include a security agreement, an order for access to medical cannabis, documents verifying ownership or lease of the premises, and the company’s articles of association and site plan.
Detailed information about the facility’s resources and staff qualifications must also be provided, along with a description of all documents submitted.
It is essential to ensure the following:
• Employment of at least three qualified staff members.
• Maintenance of comprehensive documentation, including quarterly and annual reports.
• Availability of normative-technical documentation and standardization documents, such as SOPs, technological instructions, and methodologies.
• Thorough monitoring and documentation of all licensed activities in the register.
• Adherence to best practices in agriculture and manufacturing.
NB! Licensing criteria for medical cannabis are still awaiting final approval.
Licensing Requirements for Cannabis-Related ActivitiesAll operations involving medical cannabis require specific licenses, covering:
1. Import, export, and transit. The import, export, and transit of cannabis products must be carried out by licensed entities, each of which must secure a permit for every specific operation from the SMDC. The matter will be reviewed within 30 days. Furthermore, both import and export activities also necessitate authorization from the Security Service of Ukraine.
Export is allowed only to countries where such products are legally accepted. Export permits are based on quotas and require approval from the Security Service of Ukraine.
The application to the SMDC must detail the designation, quantity, and THC content of the transported cannabis-based medicines, plants, and substances. Documents are submitted by email.
Transit requires mandatory guarding and escort by the National Police's security division.
2. Cultivation. Only licensed entities can cultivate medical hemp and cannabis, following GACP standards.
3. Storage. Designated storage sites must meet approved requirements and obtain permits from the National Police.
4. Transportation. Restricted to licensed carriers using state-owned security services and GPS-equipped vehicles.
5. Wholesale and Retail. Distribution is limited to licensed pharmacies and authorized users, such as hospitals and research institutions.
6. Destruction. Cannabis-based products must be destroyed by licensed entities under strict regulatory oversight.
NB! Licensing criteria for сannabis-related activities are still awaiting final approval.
Quota SystemThe government has introduced a quota allocation system for the manufacturing, cultivation, storage, import, and export of medical cannabis. Until 1 January 2028, there will be a zero quota on the import of cannabis plants, cannabis-derived narcotics, and psychotropic substances, with exceptions for:
• Cannabis for R&D purposes.
• Cannabis plant materials for producing medicines listed in the State Register of Medicines.
• Cannabis seeds and planting materials.
Entities must submit quota applications to the SMDC. The Ministry of Health will propose quota allocations for the following year to the Cabinet of Ministers based on SMDC data.
NB! Updates to the quota allocation procedure and key regulations are expected over the coming months.
Cannabis Pharmacopoeia RequirementsUntil Ukraine includes standards for cannabis product quality, EU pharmacopoeias, including the German Pharmacopoeia, will apply. Ukraine adopted the European Pharmacopoeia’s monograph for cannabis flowers in July 2024.
Electronic RegisterIn October 2024, an electronic system will be launched to monitor the cultivation of medical hemp plants, the movement of these plants, their processed products, cannabis plant material, and the resulting medicinal products, throughout the entire process. This system will cover cannabis seeds, planting material, plants, harvests, raw materials, processed products, and finished medicinal products. It will also track narcotic and psychotropic substances derived from cannabis, waste, and samples.
The system will monitor 31 different operations, requiring daily records for most processes. If quotas are imposed, registrations will be managed within these limits to monitor quota usage and prevent breaches. The system will notify the company and the SMDC if quota limits are exceeded. The system will be accessible to the Security Service of Ukraine, the National Police, and the Ministry of Health.
ConclusionThe Medical Cannabis Law aims to establish a strict regulatory framework for cannabis products in Ukraine. By implementing stringent licensing and quota systems, the law seeks to ensure tight control and transparency across the industry. These measures are intended to improve patient access and safety while potentially offering significant opportunities for investors. However, a disciplined approach to compliance and monitoring will be essential for realizing these potential benefits and ensuring a stable and attractive market.
