Support in Obtaining a Licence for the Use of Narcotic Drugs and Precursors
Any operations with narcotic drugs, psychotropic substances and precursors — storage, transport, acquisition, dispensing, use — are permitted only if a licence is held. No pharmacy dispensing strong painkillers, no hospital with palliative patients, and no manufacturer or research laboratory can operate without one. The cost of a mistake here is higher than in ordinary licensing: operating without a licence entails administrative and, in many cases, criminal liability. Dextra Law provides end-to-end support in obtaining this licence — from preparing the premises and personnel to filing the documents and obtaining the decision of the State Service on Medicines.
What this licence is and what “use” means
In legal terms, this is a licence to carry out economic activity involving the circulation of narcotic drugs, psychotropic substances and precursors. “Use” is one of the types of circulation covered by this licence, alongside storage, transport, acquisition, dispensing and other operations. A single licence covers the types of activity that the entity has declared and for which it has confirmed compliance with the requirements.
The legal basis comprises the Law of Ukraine “On Narcotic Drugs, Psychotropic Substances and Precursors” No. 60/95-VR, the Law of Ukraine “On the Licensing of Types of Economic Activity” No. 222-VIII and the Licensing Conditions approved by Resolution of the Cabinet of Ministers of Ukraine No. 282 of 6 April 2016. The specific substances whose circulation is controlled are set out in the Schedule approved by Resolution of the Cabinet of Ministers of Ukraine No. 770 of 6 May 2000. The licensing authority is the State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines).
Who needs the licence
The licence is required by entities that work with controlled substances in their activities. In practice, these are:
- pharmacies and pharmacy chains — for dispensing narcotic and psychotropic medicines;
- healthcare facilities — hospitals, hospices and palliative-care units that use pain relief;
- manufacturers of medicines containing controlled substances;
- research and educational institutions and laboratories — for studies and trials;
- veterinary establishments — for the relevant preparations;
- entities working with medical cannabis — at every stage of circulation.
An applicant for the licence may be a legal entity registered in Ukraine that meets the licensing conditions. A sole proprietor may obtain the licence only on condition that they hold a licence for medical or veterinary practice.
Licence for the circulation of controlled substances: the essentials at a glance
| Parameter | Details |
|---|---|
| Licensing authority | State Service on Medicines (Derzhliksluzhba) |
| Legal basis | Law No. 60/95-VR; Law No. 222-VIII; Licensing Conditions (CMU Resolution No. 282); Schedule (CMU Resolution No. 770) |
| Who may obtain it | Legal entities; sole proprietors holding a licence for medical or veterinary practice |
| Licence validity | 5 years |
| Issuance fee | One-off; UAH 3,328 in 2026 |
| Methods of submission | In person or by post with an inventory of the enclosure |
| Outcome | Entry in the Unified Licensing Register (the licence exists in electronic form) |
Which activities the licence covers
A broad list of operations with controlled substances is subject to licensing: development, production, manufacture, storage, transport, acquisition, sale (dispensing), import into and export from Ukraine, use and destruction. The cultivation of plants included in the relevant table of the Schedule is licensed separately. The entity declares the types it plans to engage in, and it is for those types that it prepares its premises, personnel and documents.
Requirements for the licence applicant
This is one of the most heavily regulated areas of licensing, and the requirements concern not only paperwork but also the physical organisation of the work:
- Premises and storage. Equipped storage locations that meet security requirements — with a security alarm and proper access protection.
- National Police permit. For the use of the sites and premises intended for activities involving controlled substances; for certain precursors the requirements differ.
- Qualified personnel. As a general rule, at least three employees of the appropriate qualification; for pharmacies, the 2025 changes lowered the threshold to two, depending on volumes.
- Fitness of the manager. A specialist’s certificate confirming the fitness of the manager or the responsible unit to work with controlled substances.
- Medical certificates for personnel. Confirming the absence of mental disorders associated with the abuse of alcohol, narcotic drugs or psychotropic substances. Important: the State Service on Medicines accepts such certificates only from state or municipal healthcare facilities — private ones do not qualify.
- Absence of a criminal record. Employees with direct access to controlled substances must have no unspent or outstanding conviction for offences related to illicit circulation, including those committed outside Ukraine.
Documents for obtaining the licence
The application in the prescribed form is accompanied by, among other things:
- a copy of the specialist’s certificate confirming the manager’s fitness;
- healthcare-facility certificates confirming the absence of the relevant mental disorders among personnel;
- information confirming the absence of personnel’s convictions for offences related to the illicit circulation of controlled substances;
- information on the National Police permit for the use of the premises;
- documents on ownership of or right to use the premises;
- information on the state of the material and technical base and the qualifications of personnel.
The licensing procedure: step by step
- Preparing the base. Equipping storage and premises, selecting and formalising personnel, and organising record-keeping and safekeeping.
- Obtaining permits and certificates. The National Police permit for the premises, medical certificates from a state or municipal facility, and the fitness certificate.
- Filing the application with the State Service on Medicines. In person or by post with an inventory of the enclosure. During martial law, a simplified procedure for issuing the licence applies.
- Review of the application. The State Service on Medicines checks the documents and decides to issue or refuse the licence; as a general rule, the period does not exceed 10 working days.
- Obtaining the licence. The licence exists in electronic form — as an entry on the licensee in the Unified Licensing Register.
Validity, fee and re-issuance
Unlike most licences, which are issued indefinitely, a licence for the circulation of narcotic drugs, psychotropic substances and precursors is valid for five years. A one-off fee is charged for its issuance, the amount of which is tied to the subsistence minimum for able-bodied persons (UAH 3,328 in 2026). When data change or the types of activity expand, the licence is re-issued, so any material changes in the licensee’s operations should be tracked in good time.
Medical cannabis: a new area under licensing control
A separate and relatively new layer is the circulation of medical cannabis. Law of Ukraine No. 3528-IX, brought into force on 16 August 2024, permitted the circulation of cannabis for medical, scientific and scientific-technical purposes, and Resolution of the Cabinet of Ministers of Ukraine No. 1123 of 30 September 2024 integrated these matters into Licensing Conditions No. 282.
The entire chain falls under licensing control — from cultivation or import to manufacturing the medicine and dispensing it to the patient at a pharmacy. Enhanced requirements have been set for cultivation: indoor (enclosed-soil) growing, round-the-clock video surveillance with National Police access, and state control over transport. Circulation is recorded in an electronic system, and the preparations are dispensed by electronic prescription. For business, this means a new but tightly controlled niche, entry into which requires the same licensing procedures with additional “cannabis-specific” requirements.
What changed for pharmacies in 2025–2026
Regulation is gradually being simplified where this does not undermine control. The 2025 changes eased the requirements for pharmacies and improved patients’ access to pain relief — in particular, by lowering the minimum number of qualified personnel. At the same time, licensees were required to submit updated information to the State Service on Medicines within a set deadline — by 18 February 2026. This means the matter concerns not only those who are only now obtaining a licence, but also those already operating who must bring their documents into line with the new requirements.
Refusal, suspension and revocation of the licence
The State Service on Medicines may refuse to issue a licence if the applicant does not ensure the safety of the activity and the recording and safekeeping of the substances, has submitted inaccurate data, or if the management or personnel include persons with the relevant medical contraindications or an outstanding conviction for “narcotics” offences. An issued licence may be suspended or revoked for a breach of the licensing conditions. Because of the high cost of such decisions, the documents and the actual state of the business must fully match before the application is filed.
Liability for operating without a licence
The circulation of controlled substances without a licence is unlawful and may be classified as an administrative or criminal offence — depending on the circumstances and the type and quantity of the substances. For a business, this is a risk not only of fines but also of the suspension of its activity and the holding of its officers liable. That is why legal status should be arranged before the actual work with substances begins, not after.
How Dextra Law supports obtaining the licence
This is a case where the main work is to prepare the business so that it passes inspection without remarks. Dextra Law’s lawyers take the process on:
- Readiness audit. We assess the premises, storage, personnel and record-keeping processes against the licensing conditions and draw up a preparation plan.
- Support with permits and certificates. We help obtain the National Police permit, correctly arrange the medical certificates at a state or municipal facility, and the fitness certificates.
- Preparation of the document package. We draw up the application and information in the prescribed forms and check them for completeness and consistency.
- Submission and communication with the State Service on Medicines. We submit the documents, support the review and handle the licensing authority’s queries.
- Cannabis and re-issuance. We support entry into the medical-cannabis area and the re-issuance of the licence when data change or activities expand.
Most refusals in this area arise from premises that fall short, “private” certificates that the State Service on Medicines does not accept, or inconsistent staffing documents. When these points are closed in advance, licensing goes through smoothly.
Frequently asked questions
Yes. Any circulation of narcotic drugs, psychotropic substances and precursors without a licence is prohibited and entails administrative or criminal liability.
The State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines). It also decides on the refusal, suspension or revocation of the licence.
Yes, but only on condition that the sole proprietor holds a licence for medical or veterinary practice. In most cases the applicants are legal entities.
No. Certificates confirming the absence among employees of mental disorders associated with the abuse of alcohol, narcotic drugs or psychotropic substances are accepted by the State Service on Medicines only from state or municipal healthcare facilities. If such certificates are obtained at a private clinic, the licensing authority will not accept them, so personnel should be referred to a state or municipal facility from the outset.
As a rule, yes — for the use of premises intended for work with controlled substances. For certain precursors the requirements may differ, so this point is checked for the specific activity.
Its circulation has been legalised for medical and scientific purposes and is fully subject to licensing control — from cultivation to dispensing at a pharmacy, with additional requirements on security and record-keeping.
Yes. The 2025 changes required existing licensees to submit updated information to the State Service on Medicines — this must be done within the set deadline, by 18 February 2026.
Need support in obtaining the licence?
The Dextra Law team will assess your business’s readiness for licensing, prepare the premises, personnel and documents, and support the procedure from filing the application to the entry in the Unified Licensing Register. Contact us to discuss your situation and draw up an action plan.
