The Ministry of Health has Defined New Rules for the Production of Medicines from Medical Cannabis in Pharmacies: What Will Change for Patients and Pharmacists

The Ministry of Health of Ukraine has taken a further step towards the practical implementation of a medical cannabis use system. Ministry of Health Order No. 706, dated 29 May 2026, introduced amendments to the Rules for the Production and Quality Control of Medicinal Products in Pharmacies. For the first time, the document clearly defines how Ukrainian pharmacies should produce medicinal products from the cannabis plant, who is authorised to do so, how their quality will be controlled, and the conditions under which patients can obtain such medicines.

This initiative does not concern the legalisation of the free sale of medical cannabis. The new rules apply exclusively to the production of extemporaneous medicinal products – that is, medicines prepared directly in pharmacies according to an individual doctor's prescription or an order from healthcare institutions.

What exactly did the Ministry of Health order change?

Order No. 706 supplemented the Rules for the Production of Medicinal Products in Pharmacies, approved by Ministry of Health Order No. 812, dated 17 October 2012, with a new Section XI, entirely dedicated to the production of medicines from the cannabis plant. The document introduces, for the first time, the definition of extemporaneous medicinal products derived from the cannabis plant. These are medicines produced in pharmacies exclusively: by doctor's prescription or on order from healthcare institutions. Thus, the new rules regulate the pharmacy production process itself, rather than the industrial manufacturing of medicinal products.

Does this mean that medical cannabis can be bought by anyone?

The new order does not permit the unrestricted sale of cannabis, nor does it allow its purchase without a medical indication. Such medicines will be dispensed via an electronic doctor's prescription or to therapeutic and preventive institutions. Furthermore, every transaction involving these medicines must be recorded in the electronic information system for accounting medical cannabis, in accordance with the Cabinet of Ministers of Ukraine Resolution No. 857, dated 25 July 2024.

In essence, the state is establishing full electronic control over the movement of the medicine, from the plant substance to the point it is dispensed to the patient.

Strict requirements have been set for pharmacies

The Ministry of Health order significantly strengthens the requirements for pharmacies intending to work with the cannabis plant substance. Specifically, mandatory incoming quality control of each received batch of raw material is stipulated. Pharmacies must verify: the manufacturer's quality certificates, the medicine's registration status, accompanying documents, invoices, laboratory control results, and the absence of any prohibitions from the State Medicines Service concerning the respective batch. The use of raw materials without passing such control is forbidden.

Cannabis will be stored in special premises

A separate section of the new rules addresses storage conditions. The cannabis plant substance must be kept only in its original packaging and stored in premises that comply with the Ministry of Internal Affairs Order No. 52, dated 29 January 2018, regarding facilities designated for activities involving narcotic drugs. This effectively means specially equipped premises with an enhanced level of security.

Who has the right to produce such medicines?

The Ministry of Health has also defined the range of employees permitted to participate in the production of such medicinal products. For this purpose, the pharmacy manager must appoint, by a separate order, an authorised person or a pharmaceutical analyst who is officially permitted to work with narcotic drugs, psychotropic substances, and precursors. Production of medicines without such permission is prohibited.

One of the main innovations of the order is the system of internal pharmacy control. If the medicine is merely packaged without alteration to its dosage form, it undergoes all types of internal pharmacy control except chemical analysis. However, if dilution or a change in dosage form is involved during production, the medicine is subject to a full range of controls, including chemical analysis.

Until the laboratory test results are obtained, the entire batch of medicinal products remains in quarantine and cannot be sold. Additionally, the order explicitly prohibits mixing different batches of the cannabis plant substance during the production of medicines.

What is the established shelf life?

As a general rule, the shelf life of cannabis-based medicines is 10 calendar days. However, the Ministry of Health has permitted an extension of this period to up to six months, provided there is scientifically confirmed data on the stability of each ingredient and compliance with the requirements of the Ministry of Health Standard ST-N MOZ 42-4.5:2015. This standard was approved by Ministry of Health order No. 398, dated 1 July 2015. If a pharmacy possesses the necessary material and technical resources, it can also independently conduct stability studies of the medicine or commission them from specialised laboratories, in accordance with Ministry of Health order No. 637, dated 31 December 2003.

Transportation and sale – only with special licences

The new regulations confirm that only business entities holding the appropriate licence for activities involving narcotic drugs are permitted to transport cannabis plant material and medicines derived from it. Such transportation must adhere to the Cabinet of Ministers of Ukraine resolution No. 366, dated 17 April 2008 (as amended by resolution No. 1005, dated 3 September 2024). The sale of these medicines is also exclusively permitted under the Licensing Conditions approved by Cabinet of Ministers of Ukraine resolution No. 282, dated 6 April 2016.

Additionally, pharmacies are obliged to notify the territorial body of the State Medicines Service within 10 calendar days of commencing the dispensing of such medicinal products.

What will change for patients?

For patients, the new order does not introduce new grounds for prescribing medical cannabis, nor does it expand the list of diseases for which it can be used. Its primary objective is to regulate the technical and legal mechanisms for producing medicines in licensed pharmacies, establishing uniform requirements for their quality, safety, control, and traceability.

In essence, the Ministry of Health is completing the formation of a regulatory framework that will enable the provision of individually prepared cannabis-based medicinal products to patients under strict state control. The new rules aim to ensure a balance between the accessibility of modern treatment for those who need it and the minimisation of risks associated with the illegal circulation of medicines containing narcotic substances.

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