On 21 December 2023, the Ukrainian parliament has passed the Law legalising the medical cannabis market and establishing the framework for its operation
Co-author Ihor Korohod
The Law covers the use of cannabis in medical, industrial and scientific fields and will come into force six months after its publication.
Key takeaways:
Licencing
Each of the activities carried out in the medical cannabis market requires licencing. These include, in particular, the cultivation of cannabis for medical purposes, its import, transportation, manufacture of medicinal products and their distribution.
Traceability requirement
The Law stipulates that medicinal cannabis is allowed in medical practice, provided that control and traceability are ensured at all stages of its circulation.
The Law provides for a set of strict requirements for entities engaged in operations with medical cannabis, including operational transparency and security of the places of cultivation, storage, and processing of such cannabis.
State registration
The Law classifies cannabis plant matter as an active pharmaceutical ingredient that is allowed to be used in the manufacture of medicinal products.
The use of medicinal cannabis is allowed in medical practice exclusively in the form of medicinal products approved for use by the Ukrainian government. Preclinical studies and clinical trials of medicinal products made from medicinal cannabis are carried out following the procedure established by the legislation on medicinal products.
The permissible percentage of tetrahydrocannabinol in cannabis for medical purposes is to be determined by the government of Ukraine.
End consumers
The Law stipulates that the sale of medicinal products made from cannabis for medical purposes shall be made exclusively based on a doctor’s prescription under an electronic prescription. The Ministry of Health is to approve a list of diseases and conditions for which patients can be prescribed medicines based on medical cannabis.
