For the first time, the Ukrainian government has regulated in detail the procedure for the circulation of medical cannabis, setting deadlines for applications for quotas for 2025 and updating licensing conditions. This decision is an important step towards regulating the use of cannabis for medical purposes, which could improve patient access to essential medicines and promote market transparency.
The procedure for applying for quotas
The first step for businesses seeking to obtain quotas for medical cannabis in 2025 is to determine the annual demand for plants, narcotic drugs and psychotropic substances. By 20 November 2024, all business entities already operating in the field of circulation of such products must submit to local state administrations a calculation of their annual demand. This calculation is included in Annex 1 of the new Procedure.
Thereafter, by 1 December 2024, companies are required to submit an application to the State Service of Ukraine on Medicines and Drugs Control (SMDC) to obtain a quota for the production, storage, import, and export of medical cannabis. This includes related materials, including planting material. Such an application must comply with Annex 2 of the Procedure.
For companies intending to cultivate medical cannabis, it is important to submit a separate application for a quota to the State Service of Ukraine on Medicines and Drugs Control by 15 December 2024.
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Quotas formation
Quotas are determined based on demand from businesses, taking into account their actual or planned turnover. This helps to avoid excessive imports and ensure the transparency of the circulation of cannabis for medical purposes. Imports in excess of the established quotas are prohibited. However, if there is a need to reallocate quotas, this can be done upon written application of both companies, but only within the annual quotas approved by the government.
Only companies that have obtained a licence are eligible to apply for a quota. Once the quotas are approved by the Cabinet of Ministers of Ukraine, licensed companies may apply for a permit to import medical cannabis in the established volumes.
Read also: Ukraine Legalizes Medical Cannabis: What’s Next
Updated rules for the circulation of medical cannabis
In addition to defining the process for obtaining quotas, the government has also updated other aspects regulating the circulation of medical cannabis:
- Annual renewal of quotas — business entities must submit annual applications for quotas to ensure that production and consumption volumes are in line.
- Waste disposal — the procedure for the disposal of medical cannabis waste has been established, which provides for the destruction of product residues in accordance with state standards.
- Internal Accounting and Inventory — updated requirements for accounting systems that companies must maintain to control the circulation of medical cannabis.
- Reporting — new requirements for reporting the amount of medical cannabis stored, produced and used by businesses have been established.
- Cultivation — specific norms and requirements for enterprises engaged in the cultivation of medical cannabis have been defined.
These updates are designed to ensure transparency and control of the medical cannabis market in Ukraine, preventing illicit trafficking and abuse.
Read also: Ukraine is getting closer to legalize: cannabis has been removed from the list of especially dangerous substances
New licence conditions enter into force
On 1 December 2024, a resolution of the Cabinet of Ministers of Ukraine will come into force, updating the licensing conditions for all stages of medical cannabis circulation. These new requirements cover all processes, from cultivation and production to storage and sale, which will create a clear legal framework for the medical use of cannabis in Ukraine.
Thus, the updated procedure and established quotas will help expand the medical cannabis market, create new opportunities for medical research, and improve patients’ access to essential cannabis-based medicines.
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