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Ukraine has officially registered its first medical cannabis-based drugs, paving the way for patients to access treatments within weeks.
Curaleaf International has successfully listed three oil-based products in the country, following the legalization of medical marijuana in August of last year.
Although these are the first products to be distributed to Ukrainian patients, they are unlikely to be the last. The emerging market has already drawn significant attention from international players eager to introduce their offerings to Ukraine.
However, companies aiming to enter this new market face a range of unique challenges that could delay their progress.
On January 9, 2025, Ukraine added its first cannabis-based drugs to the State Register of Medicines, a required step for all pharmaceutical products entering the country.
The products include three full-spectrum oils from Curaleaf, featuring balanced THC and CBD concentrations of 10 mg/ml and 25 mg/ml, as well as a THC-only option at 25 mg/ml.
According to government statements, these medications are expected to be available in pharmacies by early 2025.
Ukrainian MP Olha Stefanishyna remarked: “It’s been a year since Ukraine legalized medical marijuana.
“During this period, the legal framework has been prepared, and the first manufacturer has registered an active pharmaceutical ingredient (API). As a result, the first products will soon reach pharmacies.”
Anna Glushchenko, founder of the Ukrainian Cannabis Consulting Group, played a key role in overseeing the registration process and now collaborates with various companies to facilitate product entry into the Ukrainian market.
She explained: “This was our first experience with this process. While there were no major obstacles, the regulator was highly meticulous, carefully examining every detail. Compliance with stability standards and proper documentation in the eCTD format was crucial.”
“We’re now assisting other companies with registration, and it’s clear that many lack the required documentation for successful API approval in Ukraine.”
Glushchenko noted that while international cannabis companies are keen to enter Ukraine, many struggle to meet the strict regulatory standards set by local authorities.
“Although the process isn’t overly complicated, only companies with flawless documentation adhering to eCTD standards can achieve successful registration,” she said.
“Just because something works in Europe doesn’t guarantee it will work in Ukraine, where regulators rigorously adhere to rules.”
The uniform API registration requirements in Ukraine are more demanding than in countries like Germany or the UK, posing additional challenges for companies.
Since the market is in its infancy, Ukrainian regulators are cautiously implementing processes, which can complicate matters for companies unfamiliar with these high standards.
“Companies without fully compliant documentation often find the process daunting. We’ve encountered cases where firms accustomed to the UK or German markets were surprised by the strict Ukrainian requirements.”
Approval for import quotas is another hurdle. Companies must secure regulatory permission to import specific quantities of medical marijuana into Ukraine.
Applications for these quotas closed on December 1, 2024, and many are still awaiting approval. Without this critical step, companies cannot proceed with product registration or imports.
Beyond assisting companies with registration, Glushchenko is addressing gaps in education and logistics within Ukraine.
The Ukrainian Medical Marijuana Association is developing courses to train doctors on prescribing medical cannabis, an essential step to ensuring healthcare professionals are confident in utilizing these treatments.
International organizations are also encouraged to collaborate and support the education of Ukrainian healthcare providers in this emerging industry.
Pharmacies face their own set of challenges, as they must acquire licenses for retail, drug manufacturing, and distribution, limiting the number of dispensaries to around 200 nationwide.
Additionally, Ukraine’s trunk system requires pharmacies to produce cannabis-based drugs in-house, adding further complexity.
“Despite being classified as active pharmaceutical ingredients, cannabis products lack clear guidelines for handling within pharmacies,” Glushchenko said.
“Pharmacies are unsure of their responsibilities regarding storage, documentation, or required paperwork. This uncertainty makes them hesitant to engage in this sector.”
Even regulators face difficulties, as many frameworks and guidelines are still under development. This creates a slow and complex process, requiring coordinated efforts from various stakeholders to resolve challenges and establish clarity.
