The Ukrainian Ministry of Health has approved new rules for the compounding of medicinal products from medical cannabis in pharmacies. The document regulates the production of medications based on individual doctors' prescriptions and establishes strict requirements for their storage, quality control, and dispensing; however, it does not permit the over-the-counter sale of medical cannabis. This was reported by Dengi.ua, citing a legal analysis on YURLIGA.
What Has Changed
The new regulations were approved by Ministry of Health Order No. 706, dated May 29, 2026. The document supplements the existing rules for compounding medicines in pharmacies with a dedicated section for preparations derived from active cannabis plant substances.
This applies exclusively to extemporaneous (compounded) medications - preparations manufactured directly in a pharmacy based on an individual electronic prescription from a physician or an order from a healthcare facility. The changes do not apply to the industrial production or over-the-counter sale of medical cannabis.
Who Will Be Eligible to Receive These Preparations
The Ministry of Health emphasizes that the new rules do not expand the list of conditions for which medical cannabis is prescribed, nor do they allow such medications to be purchased without a medical indication.
Medications will be dispensed strictly based on a doctor’s electronic prescription or issued directly to healthcare facilities. Furthermore, every transaction involving these medications must be recorded in the state’s electronic medical cannabis tracking system, which will allow for monitoring their movement at every stage.
What Requirements Apply to Pharmacies?
Pharmacies handling medical cannabis are required to conduct mandatory incoming quality control inspections on each batch of raw materials. These inspections must verify quality certificates, registration documents, laboratory test results, and the absence of any ban on the use of a specific batch of the product.
In addition, cannabis plant material must be stored only in its original packaging in specially equipped facilities with enhanced security measures that comply with the requirements of legislation governing the circulation of narcotic drugs.
Only employees with official authorization to work with narcotic and psychotropic substances will be permitted to manufacture these medications. The pharmacy director will designate them by separate order.
How Quality Will Be Controlled
Mandatory in-process quality control will be implemented for these compounded medications. If a change in dosage form or dilution occurs during the manufacturing process, the medication must undergo a comprehensive suite of tests, including chemical analysis.
Until the results of laboratory tests are received, the entire batch of medications will be held in quarantine storage and cannot be released for sale. It is also prohibited to use different batches of the cannabis plant material in the manufacturing process.
What This Means for Patients
As a general rule, the shelf life of manufactured medications will be 10 calendar days. If there is confirmed data on the stability of the components, this period may be extended to six months.
The Ministry of Health notes that the primary goal of the new regulations is not to expand access to medical cannabis, but to establish a transparent mechanism for compounding medications in licensed pharmacies. This should ensure that patients have access to the necessary medications under strict government oversight of quality, safety, and legality.