Licence for Wholesale and Retail Trade in Medicinal Products: support in obtaining
A pharmacy, a pharmacy point or a pharmacy warehouse cannot operate without a licence — trade in medicines is one of the most heavily regulated activities in Ukraine. The particular feature of this licence is that it is checked “in the field”: the State Service on Medicines inspects every declared place of business before the licence is issued. In other words, you first need to have the premises, equipment and staff ready — and only then count on the authorisation. Dextra Law provides end-to-end support in obtaining a licence for wholesale and retail trade in medicinal products: from assessing the premises and staff to submitting the documents and passing the inspection.
Legal basis and licensing authority
The requirement to license trade in medicines is established by the Law of Ukraine “On the Licensing of Types of Economic Activity” No. 222-VIII and the Law of Ukraine “On Medicinal Products”. The specific requirements for the licensee are contained in the Licensing Conditions approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 of 30 November 2016. The licensing authority is the State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines).
A single Resolution No. 929 covers several different activities: (industrial) manufacture of medicines, compounding of medicines in pharmacy settings, wholesale trade, retail trade, electronic retail trade and import. The entity declares the activities it plans to carry out — and prepares a separate set of requirements for each of them.
Licence for trade in medicines: the essentials at a glance
| Parameter | Details |
|---|---|
| Licensing authority | State Service on Medicines (Derzhliksluzhba) |
| Legal basis | Law No. 222-VIII; Law “On Medicinal Products”; Licensing Conditions (CMU Resolution No. 929) |
| Who may obtain it | Legal entities and sole proprietors (FOP) |
| Licence validity | Indefinite |
| Issuance fee | One subsistence minimum for able-bodied persons (UAH 3,328 in 2026) |
| Application review period | No later than 10 working days |
| Form of the licence | Electronic — an entry in the licensing register (the paper form has been abolished) |
| Pre-issuance inspection | Mandatory, for each place of business |
| Deadline for existing licensees (Resolution No. 275) | Submit Annexes 29 and 30 by 3 November 2026 |
Through which establishments the activity is carried out
The Licensing Conditions tie each type of trade strictly to a specific type of establishment:
- Wholesale trade — through a pharmacy warehouse (base). This is a healthcare establishment that supplies medicines to other licensees, treatment-and-prevention facilities and manufacturers.
- Retail trade — through a pharmacy and its structural subdivision (a pharmacy point), as well as through a mobile pharmacy point whose details are entered in the register.
- Electronic retail trade — through a pharmacy or a pharmacy point: distance selling does not exist “on its own”; there is always a physical pharmacy establishment behind it.
- Retail trade at petrol stations — a separate format with its own requirements, limited to over-the-counter products.
- Compounding of medicines in pharmacy settings — through a pharmacy, on the basis of doctors’ prescriptions and orders from treatment-and-prevention facilities.
The key rule: trade in medicines is carried out exclusively through pharmacy establishments and may not be conducted outside them — except in the cases expressly provided for by the Licensing Conditions.
Requirements for the licence applicant
The Licensing Conditions divide the requirements into organisational, staffing and material-and-technical. In practice, it all comes down to three blocks.
Premises
A document confirming ownership of or the right to use the premises is required. The premises must correspond to their functional purpose (pharmacy, pharmacy point, pharmacy warehouse), be suitable for storing medicines in compliance with the conditions specified by the manufacturer, and have a proper layout of zones — product acceptance, storage, sales floor. The requirements for area and location differ depending on the type of establishment and the locality, so the specifics are worth checking for your site in advance: this is precisely the stage where opening plans most often fall apart.
The authorised person
This is the central figure of the licensee — it is on them that the responsibilities for the functioning of the medicines quality system are placed. As a general rule, for wholesale and retail trade a person is required with a master’s degree in “Pharmacy” (or a related field), a pharmacist-specialist certificate or a document on a qualification category, at least two years’ overall experience in the pharmaceutical field, and a completed thematic development course on ensuring the quality of medicinal products.
For the retail trade of over-the-counter medicines at petrol stations, the requirements are softer: education at the level of a professional junior bachelor in “Pharmacy” is sufficient, with no experience requirement, while the entity must have at least one authorised person.
Ownership structure
Control over the licensee’s activity by residents of states carrying out armed aggression against Ukraine is not permitted. If the fact of such control is documented, the State Service on Medicines takes a decision to revoke the licence.
Which documents are submitted
The application (for pharmacy compounding, wholesale, retail and electronic retail trade — in the form of Annex 1) is accompanied by supporting documents for each place of business:
- information on the material and technical base and qualified personnel — in a form depending on the type: retail trade (Annex 5, together with information on belonging to a pharmacy chain), wholesale trade (Annex 6), compounding in pharmacy settings (Annex 4), electronic retail trade (Annex 24), trade at petrol stations (Annex 25);
- a copy of the contract with a postal operator — for electronic retail trade, if delivery is carried out with the involvement of the post;
- information on the absence of control over the activity by residents of the aggressor state (Annex 29);
- information on the accessibility of the places of business for persons with disabilities and other low-mobility groups of the population (Annex 30);
- an inventory of documents in two copies (Annex 8) — where submitted on paper.
All documents are drawn up in the state language and signed by the licence applicant or a person authorised to act on behalf of the legal entity.
What Resolution No. 275 changed: new requirements and the 3 November 2026 deadline
This is the most topical block for the pharmacy business. Resolution of the Cabinet of Ministers of Ukraine No. 275 of 2 March 2026 amended Licensing Conditions No. 929 and entered into force on 3 May 2026. It expanded the list of documents attached to the application and supplemented the Licensing Conditions with new Annexes 26—30.
Two new documents apply to everyone without exception:
- Annex 29 — information on the absence of control over the activity by residents of the aggressor state;
- Annex 30 — information on the accessibility of the places of business for persons with disabilities and other low-mobility groups of the population.
Most importantly, the requirement concerns not only those who are only now obtaining a licence. Existing licensees are required to submit these documents to the State Service on Medicines within six months of the resolution’s entry into force — that is, by 3 November 2026. In effect, the state now checks not only the material and technical base, but also the ownership structure of the business and the accessibility of the premises.
Separately, the resolution updated the procedure regarding places of business: when a new place is created, the licensee submits a notice of change of data in the form of Annex 26.
The licensing procedure: step by step
- Preparing the site. Selecting and fitting out the premises for the type of establishment, purchasing equipment, and formalising the authorised person and staff.
- Compiling the document package. The application, information on the material and technical base and staff in the relevant form, information on the control structure (Annex 29), information on accessibility (Annex 30).
- Submission to the State Service on Medicines. By the means set out in Article 10 of Law No. 222-VIII — in particular electronically or on paper with an inventory.
- Pre-issuance inspection. The licensing authority or its territorial body necessarily checks the presence and conformity of the material and technical base and the qualifications of the staff for each place of business — within the period allotted for issuing the licence.
- Decision and entry in the register. The State Service on Medicines takes a decision no later than 10 working days from receipt of the application. The licence exists in electronic form — as an entry in the licensing register.
It is precisely the fourth step that distinguishes this licence from most others: it is not enough to fill in the paperwork correctly — what is declared must exist in reality and match the description down to the centimetre.
The licensee’s obligations after obtaining the licence
The licence is not the finish line but the start of a regime of continuous compliance:
- Electronic healthcare system. A retail-trade licensee is obliged to register in the Register of Healthcare Business Entities of the eHealth system (ESOZ) and ensure work with the system.
- New place of business. Activity may be carried out only at places whose details are entered in the licensing register. A new place is a separate procedure before it opens.
- Closure of a place. Submit an application within 10 working days of closure.
- Belonging to a pharmacy chain. Update the information within 10 working days of the changes.
- Change of data. Notify the licensing authority within a month.
- Repairs or technical re-equipment. Notify in writing no later than 10 working days before the works begin, and likewise about resumption of operation.
- Retention of documents. For the term of the licence, keep the documents confirming the accuracy of the submitted data — title documents for the premises, the technical passport, documents on the education of the manager and the authorised person, the staffing schedule, orders and employment contracts.
Electronic retail trade: what to bear in mind
A retail-trade licensee may carry out electronic retail trade in compliance with the Licensing Conditions and the Law of Ukraine “On Electronic Commerce”, organising delivery itself or through postal operators — with mandatory compliance with the storage conditions specified by the manufacturer during transport.
At the same time, medicines whose circulation requires a licence for narcotic drugs, psychotropic substances and precursors, as well as potent and poisonous preparations and those requiring special storage conditions, are not sold at a distance. Prescription medicines have a separate regime — and this is the area where a mistake costs the licence.
Features of martial law
During martial law, a number of relaxations apply: pharmacies may sell medicines to one another with the right of further sale; the transport of medicines by public transport and in postal items is permitted, as is storage in warehouses whose details are not in the licensing register; wholesalers and importers may supply medicines to military administrations, units of the Armed Forces, and organisations providing humanitarian aid. These rules are temporary, so building a long-term model on them is risky.
How Dextra Law supports obtaining the licence
In this field, a lawyer is needed not so much to fill in the application as to make sure the business approaches the inspection without remarks:
- Premises and project audit. We assess the site for compliance with the requirements for a pharmacy, pharmacy point or warehouse before the lease or renovation — this is the cheapest moment to spot a problem.
- Staffing. We check the documents of the authorised person and the manager, their qualifications and experience, and prepare the staffing package.
- Document package. We draw up the application and information in the relevant forms, including the new Annexes 29 and 30, and reconcile them with each other and with the actual state of the site.
- Inspection support. We prepare the establishment for inspection at each place of business and support the interaction with the State Service on Medicines.
- Bringing into line with Resolution No. 275. We help existing licensees meet the 3 November 2026 deadline.
- Expansion and protection. We support the opening of new places, expansion into e-retail, and disputes over refusal, suspension or revocation of the licence.
The most expensive mistakes in pharmacy licensing happen not at the submission stage but earlier — when the premises are already leased and renovated, yet they do not pass the requirements. An audit at the start saves months.
Frequently asked questions
The State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines). A decision to issue or refuse is taken no later than 10 working days from receipt of the application.
The licence is indefinite. The paper form has been abolished — the licence exists as an entry in the licensing register.
Yes. The Licensing Conditions apply both to legal entities regardless of the form of ownership and to sole proprietors.
Electronic retail trade is carried out through a pharmacy or pharmacy point: there is always a physical pharmacy establishment behind it, and the application is accompanied by separate information (Annex 24) and, if needed, a contract with a postal operator.
Information on the absence of control by residents of the aggressor state (Annex 29) and information on the accessibility of the premises for persons with disabilities and low-mobility groups (Annex 30) — this is required by Resolution No. 275.
Yes, and this is the key feature. The presence and conformity of the material and technical base and the qualifications of the staff are necessarily checked at each place of business before the licence is issued.
For wholesale and retail trade — a master’s degree in “Pharmacy” (or a related field), a pharmacist-specialist certificate or a document on a qualification category, at least two years’ experience, and a thematic development course on medicines quality. For over-the-counter trade at petrol stations, the requirements are lower.
In particular, where control over the licensee’s activity by residents of states carrying out armed aggression against Ukraine is documented, and for breach of the Licensing Conditions.
Need support in obtaining a pharmacy licence?
The Dextra Law team will check your site’s and staff’s readiness for licensing, prepare the documents and support the procedure through to the entry in the licensing register. If you already hold a licence, we will help you meet the requirements of Resolution No. 275 on time. Contact us to discuss your situation and draw up an action plan.
