October 2024
During September and early October, the Ukrainian government adopted secondary legislation to further the implementation of the so-called Cannabis Law, which came into force on 16 August 2024[1].
Below is a brief overview of the key updates:
Electronic Information System for Accounting and Ensuring the Traceability of Medical Cannabis
On 1 October 2024, a system was officially launched whereby all medical cannabis substances, all entities planning to engage in the activities related to the circulation of medical cannabis, as well as all operations involving medical cannabis (from the purchase of plant seeds to the destruction of waste), must be registered in a special system.
Licensing Conditions Regulating the Circulation of Medical Cannabis have been adopted
On 30 September 2024, the government approved licensing conditions for the cultivation, development, production, manufacturing, storage, transportation, acquisition, sale, import and export, use, utilization, and disposal of cannabis plants, raw materials, and any medicines derived therefrom[2]. They will come into force on 1 December 2024.
The licensing conditions detail an exhaustive list of mandatory requirements for the economic activities related to the circulation of cannabis, as well as a comprehensive list of documents required to obtain a license to carry out such activities.
Manufacture and Prescription of Cannabis Medicines Subject to Regulation
On 13 September 2024, the Ministry of Health of Ukraine approved (i) a list of forms of medicines that can be manufactured at pharmacies from cannabis plant substances, (ii) a list of diseases for which such medicines can be prescribed, and (iii) the peculiarities of their prescribing and medical use[3].
- Medicines derived from cannabis plant substances can be manufactured as oral liquids, hard capsules, and oral cavity pastes (gels).
- The list of diseases for which cannabis medicines can be prescribed includes, inter alia, Parkinson’s disease, refractory epilepsy, nausea and vomiting caused by chemotherapy, and chronic neuropathic pain caused by certain conditions.
- Medicines derived from cannabis can be prescribed only if treatment by registered medicines (or unregistered medicines recommended by a foreign country’s official medical body) either fail to provide the expected effect or are poorly tolerated by patients.
We will continue to monitor future legislative and regulatory developments and will keep you informed of any changes.
Contacts
If you have any questions regarding the new law, please contact:
Anastasiya Bolkhovitinova, Partner, anastasiya.bolkhovitinova@kinstellar.com.
Larysa Gorbunova, Senior Associate, larysa.gorbunova@kinstellar.com.
[1] The Law of Ukraine “On Amendments to Certain Laws of Ukraine Regarding the State’s Regulation of the Circulation of Plants of the Cannabis Genus (Cannabis) for Use in Learning Purposes, Educational, Scientific and Scientific and Technical Activities, the Production of Narcotic Drugs, Psychotropic Substances and Medicines and to Expand Patient Access to Necessary Treatments” No. 3528-IX, dated 21 December 2023
[2] Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine No 282 dated 6 April 2016” No 1123 dated 30 September 2024.
[3] Order of the Ministry of Health of Ukraine “On Approval of the List of Forms of Medicinal Products that can be Manufactured in a Pharmacy from Cannabis Plant Substance, the List of Diseases and Conditions for which Medicinal Products that can be Manufactured in a Pharmacy from Cannabis Plant Substance are Prescribed, and the Peculiarities of Prescribing and Medical Use of Medicinal Products that can be Manufactured in a Pharmacy from Cannabis Plant Substance” No 1586 dated 13 September 2024
