Cannabis law and legislation in Ukraine

Medical use

Ukraine has recently adopted a new legal framework for medical cannabis, which will enhance patients’ access to cannabis-based treatment. It also notably eases regulations on the cultivation, processing and use of industrial hemp. The Law regulating the circulation of cannabis in Ukraine (the “Cannabis Law”) is set to take effect on 16 August 2024.

Under the Cannabis Law, cultivation, processing, manufacturing and compounding, wholesale and retail, import and export are permitted for: (i) medical cannabis; (ii) products of its processing; and (iii) cannabis substances, all solely for medical, R&D and educational purposes.

Licensing and quota requirements

Any medical cannabis-related activities in Ukraine are subject to licensing.

Cultivation, storage, manufacturing, pharmacy compounding, import and export of medical cannabis and cannabis substances are subject to quota allocation by the government. The Ukrainian government allocates quotas annually on the basis of proposals from the Ministry of Health, submitted based on the quota applications from companies, healthcare, R&D and educational institutions.

Until 2028, the Cannabis Law establishes a zero quota for the import of cannabis plants and cannabis substances, except for:

  • cannabis plants and substances for R&D purposes;
  • cannabis plant materials for pharmaceutical manufacturing and compounding;
  • finished and authorised for marketing cannabis-based medicines;
  • cannabis seeds and planting material for cultivation.

Regulatory requirements for cannabis-based medicines

For medical practice, cannabis-based products must either be authorised for marketing (registered) as finished medicinal products, or produced by pharmacies licensed for pharmaceutical compounding. Both options require the use of authorised (registered) active pharmaceutical ingredients (APIs) and excipients in compliance with Pharmacopoeial standards.

In Ukraine, patients can only obtain cannabis medicines through electronic prescriptions. They are allowed to possess and travel with these medicines, provided that the quantities do not exceed those specified in the prescription.

Cultivation of medical cannabis

Medical cannabis is defined as cannabis plants grown from certified seeds of medicinal plant species, with a tetrahydrocannabinol (THC) content of 0.3% or more in dried straw, and used exclusively for education, R&D, manufacturing or compounding of medicinal products and cannabis substances for further medical use.

Other requirements for the cultivation of medical cannabis encompass:

  • Exclusive cultivation in closed soil as per government-regulated procedures.
  • Labelling of individual plants.
  • Tracing of individual plants through an electronic system.
  • 24/7 video surveillance.
  • Appropriate theft safeguards, including guarding of the cultivation sites by the security division of the national police.
  • Lab testing of THC content before harvesting.

Transportation and traceability rules

Cannabis Law introduces stringent rules to ensure the proper transportation of medical cannabis and cannabis substances, including the mandatory involvement of a state-owned security service provider.

Furthermore, to ensure traceability, each medical cannabis plant, batch, and package of cannabis substances, as well as cannabis medicines, must bear a distinctive electronic identifier. The retail sale of cannabis medicines must be recorded in an electronic system following a procedure approved by the government.

Recreational use

The recreational use of cannabis in Ukraine remains prohibited.

The cultivation, production, purchase, storage, transportation and sale of cannabis for recreational use triggers administrative or criminal liability depending on the volume and nature of the activity.

Industrial use

The cultivation and utilisation of industrial cannabis hemp in Ukraine are subject to specific requirements.  Presently, its cultivation and use are very restricted, permissible only within annually approved quotas set by the government, and require a licence.

As of 16 August 2024, regulations pertaining to the use of industrial hemp will undergo substantial relaxation. Industrial hemp is defined as cannabis plants grown from certified seeds of agricultural plant species, with a THC content of 0.3% or less in dried straw, and used exclusively for industrial purposes. Until 16 February 2027, the THC content in industrial hemp must not exceed 0.2% in dried straw.

The cultivation, processing and use of industrial hemp will no longer necessitate authorisation and quotas; only notification to the authorities will be required. However, the harvesting of industrial hemp will mandate preliminary lab testing of THC content. Any surpassing of the permitted THC content in the dried straw of a harvest will lead to the complete destruction of the harvest. Additionally, re-classification of industrial hemp into medical cannabis is prohibited.

Products derived from industrial hemp and its processing are not considered narcotics as long as their THC content adheres to the limits set for industrial hemp. Consequently, industrial hemp holds potential for diverse commercial and industrial applications, such as food, wellness products, apparel, building materials, etc.

CBD isolate is currently excluded from the list of controlled substances. However, due to the lack of clear regulations surrounding CBD in the past, the commercialisation of CBD-based products such as oils, cosmetics, and veterinary products carried certain risks. The implementation of new regulations regarding industrial hemp will facilitate the commercialisation of CBD-based non-medical products in Ukraine.

Furthermore, as Ukraine moves towards European standards in the food industry, CBD-based food and food supplements could potentially be required to undergo registration as novel foods under Ukrainian law.

Patentability

Ukrainian laws do not impose a general prohibition on patenting cannabis-based products. However, inventions (utility models) are not patentable if they contradict public order or the principles of morality.

Latest developments

On 21 December 2023, the Ukrainian Parliament adopted the Cannabis Law. The legalisation of medical cannabis marks a significant milestone in patient treatment in Ukraine. Cannabis medicines are expected to be particularly beneficial in the treatment of conditions such as oncology, epilepsy, post-traumatic stress disorder (PTSD), and other conditions. Furthermore, the deregulation of industrial hemp presents benefits for agricultural businesses and fosters new investment opportunities.

Before 16 August 2024, the Ukrainian government is expected to develop new regulations dealing with medical cannabis, including:

  • A list of permitted forms of cannabis medicines for finished medicines and for pharmacy compounding.
  • A list of diseases/conditions eligible for the prescribing of cannabis medicines.
  • A regulation on prescribing and the medical use of cannabis medicines.
  • Guidelines regarding the procedure for acquiring plant seeds for medical cannabis cultivation.

Over the next few months, the government will also amend key existing regulations related to medical cannabis, including:

  • Updating the list of controlled psychoactive and narcotic substances.
  • Amending procedures for conducting activities involving the circulation of psychoactive and narcotic substances.
  • Revising the procedure for annual quota allocation to extend it to medical cannabis.
  • Revising the rules for compounding and quality control of medicines in pharmacies.

The Ukrainian Pharmacopoeia will undergo updates to incorporate requirements for cannabis-based APIs, medicines, their packaging, storage conditions, shelf life, as well as quality control methods. In the interim, the pharmacopoeias of EU member states, including the German Pharmacopoeia, will be applicable.

Portrait ofBorys Danevych
Borys Danevych
Partner
Kyiv (CMS CMNO)
Portrait ofAnastasiia Maistruk
Anastasiia Kulykova
Associate
Kyiv (CMS CMNO)