According to Ukrainian media reports, the first batch of medical cannabis products has been officially registered in Ukraine, which means that patients in the country should be able to receive treatment in the coming weeks.
Famous medical cannabis company Curaleaf International announced that it has successfully registered three different oil-based products in Ukraine, which legalized medical cannabis in August last year.
Although this will be the first batch of medical cannabis companies to distribute their products to patients in Ukraine, it will by no means be the last, as there are reports that this new market for medical cannabis in Ukraine has received “great attention from international stakeholders”, many of whom hope to get a share of the pie in Ukraine. Ukraine has become a hot commodity.
However, for companies eager to enter this new market, many unique and complex factors may prolong their market launch time.
background
On January 9, 2025, the first batch of medical cannabis products were added to the Ukrainian National Drug Registry, which is a mandatory procedure for all cannabis raw materials (APIs) to enter the country.
This includes three full spectrum oils from Curaleaf, two balanced oils with THC and CBD contents of 10 mg/mL and 25 mg/mL, respectively, and another cannabis oil with THC content of only 25 mg/mL.
According to the Ukrainian government, these products are expected to be launched in Ukrainian pharmacies in early 2025. Ukrainian People’s Representative Olga Stefanishna told local media: “Ukraine has been legalizing medical marijuana for a whole year now.
During this period, the Ukrainian system has prepared for the legalization of medical cannabis drugs at the legislative level. The first manufacturer has already registered cannabis API, so the first batch of drugs will soon appear in pharmacies
The Ukrainian Cannabis Consulting Group, founded by Ms. Hannah Hlushchenko, supervised the entire process and is currently collaborating with more medical cannabis companies to introduce their products into the country.
Ms. Helushenko said, “We went through this process for the first time, and although we didn’t encounter too many difficulties, the regulatory authorities were very meticulous and carefully reviewed every detail of the registration point. Everything must strictly comply with stability and compliance requirements, including using the correct drug registration standard (eCTD) format for documents.
Strict requirements
Ms. Hlushenko explained that despite strong interest from international cannabis companies, some companies still struggle to register their products due to the strict and unique standards required by Ukrainian authorities. Only companies with excellent regulatory documents that fully comply with the drug registration standards (eCTD) can successfully register their products.
These strict regulations stem from Ukraine’s API registration process, which is uniform for all APIs regardless of their nature. These regulations are not necessary steps in countries such as Germany or the UK.
Ms. Hlushchenko stated that given Ukraine’s status as an emerging market for medical cannabis, its regulatory authorities are also “cautious about everything,” which could pose challenges for companies that are unfamiliar or unaware of these high standards.
For companies without complete compliance documents, this process can become quite difficult. We have encountered situations where companies accustomed to selling products in markets such as the UK or Germany find Ukraine’s requirements unexpectedly harsh. This is because Ukraine’s regulatory authorities strictly adhere to every detail, so successful registration requires adequate preparation
In addition, the company must first obtain approval from regulatory authorities to obtain quotas for importing specific quantities of medical marijuana. The deadline for submitting these quotas is December 1, 2024, but many of the applications have not yet been approved. Without prior approval (known as the ‘key step in the process’), companies cannot register or import their products into the country.
Next market action
In addition to helping businesses register their products, Ms. Hlushchenko is also committed to filling the education and logistics gaps in Ukraine.
The Ukrainian Medical Cannabis Association is preparing courses for doctors on how to prescribe medical cannabis, which is a necessary step to understand the market and ensure that medical professionals have confidence in prescribing. At the same time, the association is also inviting international parties interested in developing the Ukrainian medical cannabis market to join forces and help doctors understand how the industry operates.
Pharmacies also face uncertainty. Firstly, each pharmacy needs to obtain licenses for retail, drug production, and sale of narcotic drugs, which will limit the number of pharmacies capable of issuing medical cannabis prescriptions to around 200.
Ukraine will also adopt a local drug supervision and management system, which means that pharmacies must produce these preparations internally. Although medical cannabis products are considered active pharmaceutical ingredients, there are no clear instructions or regulatory frameworks for handling them in pharmacies. In fact, pharmacies are unsure of their responsibilities – whether to store products, how to record transactions, or what paperwork is needed.
Due to many necessary guidelines and frameworks still being developed, even regulatory representatives may sometimes feel confused about certain aspects of the process. The overall situation remains complex, and all stakeholders are working hard to address these challenges and clarify the process as soon as possible to seize the opportunity to enter the emerging market of Ukraine
Post time: Jan-20-2025