The first medical cannabis products have officially been registered in Ukraine, meaning patients should be able to access treatment in the coming weeks.
Curaleaf International has successfully registered three separate oil-based products in the country, which legalised medical cannabis last August.
While it will be the first to see its products distributed to patients in the country, it will not be the last, as sources suggest the new market has received ‘considerable attention from international stakeholders,’ many of which are eager to introduce products in Ukraine.
However, for businesses keen to break into this new market, there are a number of unique complexities that could prolong the rollout of the market.
What happened?
On January 09, 2025, the first products were added to Ukraine’s State Register of Medicinal Products, a process which is required for all API’s coming into the country.
These included three full-spectrum oils from Curaleaf, two balanced oils with either 10mg/ml or 25mg/ml of THC and CBD, and one with just 25mg/ml of THC.
According to the government, these products should be ‘available in Ukrainian pharmacies in early 2025.’
Olga Stefanyshyna, a People’s Deputy of Ukraine, told local media: “A year has passed since Ukraine adopted a law on the legalisation of medical cannabis.
“During this time, the Ukrainian system has been prepared at the legislative level for the legalisation of medical drugs. The first manufacturer has already registered an active pharmaceutical ingredient (API), so the first medicines will soon appear in pharmacies.”
The Ukrainian Cannabis Consulting Group, founded by Hanna Hlushchenko, oversaw the entire process and is now working with more companies to bring products into the country.
She told Business of Cannabis: “We had to navigate this process for the first time, and while there weren’t major difficulties, the regulator was highly meticulous, scrutinising every detail of the registration points. Everything had to strictly adhere to stability and compliance requirements, including documentation in the proper eCTD format (the standard for registering pharmaceuticals).
“Currently, we are assisting other companies with registration, and we’re already seeing that many lack the proper documentation needed to successfully register APIs in Ukraine.”
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Strict requirements
She explained that, despite significant interest from international cannabis businesses, some companies are struggling to get their products registered due to the strict and unique standards demanded by Ukrainian authorities.
“Ultimately, while the process itself isn’t overly complex, only companies with excellent regulatory documentation in full compliance with eCTD standards can successfully register their products,” she continued.
“The logic that something worked elsewhere in Europe does not guarantee it will work in Ukraine, where regulators follow the rules to the letter.”
These strict regulations stem from Ukraine’s active pharmaceutical ingredient (API) registration process, which is uniform across all APIs regardless of their nature and is not a necessary step in countries like Germany or the UK.
According to Ms Hlushchenko, given the market is so new, Ukrainian regulators are also ‘approaching everything cautiously’, which can create challenged for companies unfamiliar or unsuspecting of these high standards.
“For companies without fully compliant documentation, the process can become quite difficult. We’ve already encountered cases where companies, accustomed to selling in markets like the UK or Germany, find Ukraine’s requirements unexpectedly demanding.
“This is because the Ukrainian regulator follows every detail by the book, making thorough preparation essential for successful registration. These stricter standards may pose critical challenges for some companies entering the Ukrainian market.”
Furthermore, companies must first secure regulatory approval for a quota to import specific amounts of medical cannabis into the country.
The deadline for the submission of these quotas passed on December 01, 2024, and many of these applications are yet to be approved.
Without prior approval, described as a ‘critical step in the process,’ companies cannot proceed with registration or import their products into the country.
Next steps for the market
Aside from helping businesses get their products registered, Ms. Hlushchenko is also working to plug the educational and logistical gaps inside the country.
The Ukrainian Association of Medical Cannabis is working to prepare courses for doctors to educate them on how to prescribe medical cannabis, an ‘essential’ step to build an understanding of the market and ensure healthcare professionals are confident in prescribing.
It is also now inviting international parties interested in developing the Ukrainian market to join forces and help educate doctors around how the industry operates.
Pharmacies also face uncertainties. Firstly, each will need to acquire licences for retail trade, manufacturing of medicines and trafficking in narcotic substances, limiting the number capable of handling medical cannabis to around 200.
Ukraine will also use a magistral system, meaning pharmacies will be required to produce these preparations in-house.
“While cannabis products are considered active pharmaceutical ingredients, there is no clear instruction or framework for handling them within pharmacies,” Ms. Hlushchenko continued.
“Ukrainian pharmacies are unsure about their responsibilities—whether they should stock the products, how to document their transactions, or what paperwork is required. These uncertainties make pharmacies hesitant to engage.
“Even regulatory representatives sometimes struggle with aspects of the process, as many of the necessary guidelines and frameworks are still under development. The overall situation remains complex, and progress is slow as various stakeholders work to address these challenges and clarify the process.”
This article was originally published by Business of Cannabis and is reprinted here with permission.
The post Ukraine Registers First Products Ahead of Medical Cannabis Rollout appeared first on Cannabis Health News.
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Author: Business of Cannabis
