Inpharmatis

On 16 February 2025, it will be a year and a half since the on the of for medical purposes came into effect in . Law of Ukraine No. 3528-IX officially entered into force on 16 August 2024.

Key Provisions of the Law
🔹 Medical Use: The law permits the use of - for treating conditions such as chronic pain, cancer, and post-traumatic stress disorder.
🔹 Prescription Requirement: Cannabis-based are available only via doctor’s prescription.
🔹 Cultivation and Production: Cannabis can be cultivated and processed by licensed entities under strict regulations, including 24-hour video surveillance and compliance with ( ) standards.
🔹 Regulatory Oversight: The Ministry of Health is responsible for approving the list of qualifying medical conditions and overseeing the implementation of the law.
🔹 Industrial and Scientific Use: The law also allows cannabis cultivation for industrial and scientific purposes, with the maximum permissible tetrahydrocannabinol (THC) content in dried h**p straw set at 0.3% from 16 February 2027.

Also, the State Expert Centre of Ukraine presented methodological recommendations on the use of medical cannabis "Medical cannabis: clinical and pharmacological characteristics and regulations for use". The document is based on the latest and (Israel, Canada and other countries) and will become a practical guide for doctors when prescribing therapy to patients.

🌐 More info - https://inpharmatis.com/methodological-recommendations-for-doctors-on-the-use-of-medical-cannabis-have-appeared-in-ukraine/

⚠️ On 18 November 2025, the Minister of Health of the Republic of signed Order No. 146 introducing amendments to the rules for and re-registration of and medical devices, originally approved by Order No. ҚР ДСМ-16 dated 9 February 2021.

The new amendments affect key aspects of working with ( ), particularly their validity periods, as well as the specific features of registering . Although the volume of changes is relatively small, they are significant for stakeholders in the pharmaceutical market and aim to harmonise national legislation with the rules of the Eurasian Economic Union ( ).

📌 Key Changes - https://inpharmatis.com/kazakhstan-updates-the-rules-for-registering-strategically-important-medicines-and-maintaining-the-national-drug-registry/

👉 Why This Matters

🔹 The amendments establish a transitional mechanism that balances compliance with EAEU requirements and maintaining the availability of medicines for the population of Kazakhstan.

🔹 The changes create a strong foundation for integrating the into the EAEU framework while minimising the risk of disruptions in the supply of .

🔹 Pharmaceutical companies still have time until the of the to their in accordance with the updated requirements.

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