Pharmacy Licence: how to open a pharmacy in Ukraine in 2026
The pharmacy business is attractive for its steady demand, but entry into it works differently from most sectors. Here you cannot register first and “fine-tune” to the requirements later: a pharmacy licence is issued only after the state has inspected the specific premises, equipment and staff. In other words, the money for rent, renovation and fittings goes out before you obtain the right to operate. A mistake at the start is not a “get fined and move on” situation — it is months and budget invested in a site that does not meet the standards. This material is Dextra Law’s practical guide along the whole path: from choosing the form of business to opening the pharmacy’s doors to its first customers.
What a pharmacy licence is and why you cannot get it “on the fly”
The retail trade in medicinal products is a licensed type of economic activity. Without a licence, a pharmacy, a pharmacy point or a pharmacy warehouse cannot operate, and trade in medicines outside pharmacy establishments is prohibited, except for a few exceptions expressly set out in the legislation.
The key feature of this licence is the mandatory inspection before issuance. The licensing authority examines each declared place of business: whether the premises exist, whether they meet the standards, and whether the required equipment and qualified staff are in place. This is exactly why opening a pharmacy is not about “filing an application and waiting”, but about preparing a fully ready site and only then launching the procedure.
It is worth distinguishing the establishment formats from the outset, because both the requirements and the documents depend on them:
- Pharmacy — the main retail establishment with a sales floor, where medicines are dispensed to the end consumer.
- Pharmacy point — a structural subdivision of a pharmacy with lower area requirements.
- Pharmacy warehouse (base) — for wholesale trade and supply to other licensees and healthcare facilities.
- Electronic retail trade — online sale, always backed by a physical pharmacy or pharmacy point.
Legislative base: what pharmacy licensing rests on
To find your way with confidence, it helps to keep the full “stack” of documents in view, not just one resolution.
| Document | What it governs |
|---|---|
| Law “On Medicinal Products” | The basic framework for the circulation of medicines, including retail trade |
| Law “On the Licensing of Types of Economic Activity” No. 222-VIII | The general licensing procedure, deadlines and grounds for refusal |
| Licensing Conditions (CMU Resolution No. 929) | An exhaustive list of requirements for premises, staff and documents |
| CMU Resolution No. 275 (2026) | The latest amendments to the Licensing Conditions, new annexes and a deadline for existing pharmacies |
| Order of the Ministry of Health No. 455 of 30.05.2013 | Good Pharmacy Practice (GPP) — quality standards for pharmacy services |
| Law “On Electronic Commerce” | Rules for distance (electronic) retail trade in medicines |
The licensing authority is the State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines). The licence is indefinite and exists in electronic form as an entry in the licensing register; there is no separate paper form. A decision to issue or refuse is taken no later than 10 working days from receipt of the application — but that is the review period, not the time to opening: the bulk of the time is eaten up by preparing the site.
Step zero: the form of business and taxation
A pharmacy licence can be obtained by both a legal entity and a sole proprietor (FOP). The choice between a limited liability company (TOV) and a sole proprietorship is not a formality but a decision that shapes liability, the ability to bring in investors and ease of scaling. A FOP is simpler to administer and suits a single pharmacy; a TOV is more logical if you are planning a chain, partners, or a sale of the business in the future.
On taxation there is a nuance that is often overlooked. A pharmacy can operate on either the general system or the simplified one (single tax), if it fits within the latter’s limits. But single-tax payers who sell medicines and medical devices for cash are required to use an RRO or a software RRO (cash register) — the simplified system does not exempt them from it. The relevant activity code (KVED) for retail is 47.73, “Retail sale of pharmaceutical goods in specialised stores”. The specific tax system is worth calculating with an accountant for your expected turnover, because at the scale of a chain the general system often turns out to be more advantageous.
Premises: the main filter of the whole project
It is the premises that most often decide the fate of the opening. The requirements depend on the type of establishment and on whether it is in a city or a village. The figures below are minimums, and they should be checked against the current wording of the Licensing Conditions, since the norms have been liberalised several times in recent years.
| Type of establishment | Minimum area |
|---|---|
| Pharmacy in a city | Sales floor — at least 18 m² |
| Pharmacy in a village | Total area — at least 18 m²; sales zone — at least 6 m² |
| Pharmacy point | At least 10 m² |
Besides the floor area, there are requirements as to location and layout. A pharmacy must be in a building removed from the housing stock, or in a built-in isolated space on the ground floor with a separate exit to the outside from the sales floor. The premises are zoned for the technological process — goods acceptance, storage, sales floor — and for village pharmacies the requirements for separate rooms were recently relaxed: it is enough to allocate a sales zone within the total area. A mandatory condition is equipment for storing medicines in compliance with the conditions specified by the manufacturer, and devices to monitor temperature and humidity. This is not bureaucracy: the cold chain for some products is a question of their fitness for use.
A practical piece of advice we repeat to every client: show the premises to a lawyer before signing the lease, not after the renovation. A check “on the shore” costs hours of work; a mistake costs months and budget.
The authorised person and staff
The authorised person is the central figure of the licensee, responsible for the medicines quality system. For retail trade, this must be a specialist 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 field, and a completed thematic development course on ensuring the quality of medicinal products. In addition, the establishment must have a manager with appropriate qualifications.
An exception is made for the retail trade of over-the-counter medicines at petrol stations: there, education at the level of a professional junior bachelor in “Pharmacy” is sufficient, with no experience requirement, provided there is at least one authorised person. There is no such relaxation for a classic pharmacy.
Which documents are submitted
The document package is compiled for each place of business. The core is as follows:
- an application for a licence in the prescribed form (Annex 1);
- information on the material and technical base and qualified staff — in the form corresponding to the type of activity (for retail trade, Annex 5, together with information on belonging to a pharmacy chain);
- 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 (Annex 30);
- for electronic retail trade — separate information (Annex 24) and, if necessary, a copy of the contract with a postal operator;
- an inventory of documents in two copies (Annex 8) — where submitted on paper.
All documents are drawn up in the state language. Annexes 29 and 30 are relatively new, and they deserve particular attention — more on them below.
A step-by-step plan for opening a pharmacy
Let us bring it all into a single route. The order of the steps is not random — it is built so as not to spend money before there is confidence that the site will “take off”.
- Concept and location. Decide on the format (pharmacy or pharmacy point), city or village, approximate footfall and product range. The area requirements depend on this.
- Form of business. Choose a TOV or a FOP, register the entity, add KVED 47.73, and decide on the tax system.
- Legal audit of the premises. Check the premises for compliance with the norms on area, floor level, separate entrance and the possibility of zoning — before signing the lease.
- Lease or purchase. Formalise the right to use the premises in documents: without this, the licence cannot be obtained.
- Renovation and zoning. Set up the zones, install storage equipment and devices for monitoring temperature and humidity.
- Staff. Formalise the authorised person and the manager; check their diplomas, certificates and experience.
- Document package. Prepare the application and information in the relevant forms, including Annexes 29 and 30, reconciled with the actual state of the site.
- Submission to the State Service on Medicines. Submit the documents electronically or on paper with an inventory.
- Inspection and decision. Undergo the inspection of the place of business; based on the results, the State Service on Medicines decides to issue the licence and makes an entry in the register.
- Connecting to the systems and launch. Register in the electronic healthcare system, if needed conclude a contract with the NHSU under the Affordable Medicines programme — and open.
What Resolution No. 275 changed, and why it concerns even existing pharmacies
The most topical news of the season. CMU Resolution No. 275 of 2 March 2026 amended the Licensing Conditions and entered into force on 3 May 2026. It supplemented the conditions with new annexes and expanded the list of documents, and two of them are now mandatory for everyone: 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).
The main point is that this is not only about new pharmacies. 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 has widened the subject of oversight: it now checks not only the material and technical base, but also the ownership structure of the business and the pharmacy’s accessibility. Anyone who has been operating for a long time and assumes that “the licence is already there” risks missing this deadline — and that is a direct threat to the licence.
After opening: a pharmacy is a regime, not a one-off procedure
Obtaining the licence is half the job. Then continuous compliance begins, and it is monitored.
- Electronic healthcare system. A retail-trade pharmacy registers in the Register of Business Entities of the eHealth system (ESOZ) and works through a medical information system — pharmacists see electronic prescriptions and dispense against them.
- Affordable Medicines. To dispense reimbursed products, a pharmacy concludes a contract with the National Health Service of Ukraine (NHSU). This is not an obligation but an opportunity — and at the same time a powerful driver of footfall.
- New places and changes. Activity may be carried out only at places entered in the register; a new place is a separate procedure before opening. Closure of a place or a change of data is notified within the set deadlines, and repairs — no later than 10 working days before the works begin.
- Retention of documents. For the term of the licence, you must keep the documents confirming the accuracy of the submitted data: title documents for the premises, the technical passport, the diplomas and certificates of the manager and the authorised person, the staffing schedule and orders.
- GPP. Good Pharmacy Practice is not a declaration but a standard against which the quality of pharmacy services and pharmaceutical care is assessed.
The electronic pharmacy: special attention to prescription medicines
Online sale of medicines is legal, but with clear limits. A retail-trade licensee may carry out electronic retail trade in compliance with the Licensing Conditions and the Law “On Electronic Commerce”, organising delivery itself or through postal operators — and with mandatory preservation of 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 dispensing regime — and here the price of carelessness is measured not in a fine but in the licence.
Why pharmacies are refused: typical mistakes
In most cases the problem is not in the idea itself, but in the details that surface too late:
- the premises are already leased and renovated but do not pass on area, floor level or separate entrance;
- the authorised person lacks the required qualifications, experience or a completed thematic development course;
- the documents are internally contradictory — the information on the material and technical base does not match the actual state of the site;
- the new Annexes 29 and 30 are ignored, or the deadline for existing licensees is missed;
- online sale is built without regard to the restrictions on prescription and controlled products.
How Dextra Law supports the opening of a pharmacy
Pharmacy licensing is the field where a lawyer earns their value long before the application. We come in at the stage where expensive mistakes can still be avoided cheaply, and we run the project through to the first receipt at the till. Dextra Law takes on:
- Legal audit of the premises. We assess the site for compliance with the requirements before the lease or renovation — the cheapest point at which to find a problem.
- Business structure. We help choose between a TOV and a FOP, register the entity, and select the tax system for your model.
- Staffing. We check the documents of the authorised person and the manager and prepare the staffing package to meet the Licensing Conditions.
- The full document package. We draw up the application and information in the forms, including Annexes 29 and 30, and reconcile them with each other and with the actual state of the pharmacy.
- Inspection support. We prepare the establishment for inspection and handle the interaction with the State Service on Medicines through to the entry in the register.
- Bringing into line with Resolution No. 275. We help existing pharmacies meet the 3 November 2026 deadline and close the new requirements without risk to the licence.
- Development and protection. We support the opening of new places, entry into electronic retail trade, connection to Affordable Medicines, and disputes over refusal, suspension or revocation of the licence.
Instead of assembling the procedure yourself from dozens of rules and risking months, you get a ready-made route and a team that walks it with you. That is the difference between “opening a pharmacy someday” and “opening a pharmacy on time”.
Frequently asked questions
The State Service of Ukraine on Medicines and Drugs Control (the State Service on Medicines). A decision is taken no later than 10 working days from receipt of the application.
A one-off state fee is charged for issuance, equal to one subsistence minimum for able-bodied persons (UAH 3,328 in 2026). The main costs of opening are the premises, renovation, equipment and staff, not the licence itself.
Indefinitely. The licence exists as an entry in the licensing register; there is no separate paper form.
Yes. The Licensing Conditions apply both to legal entities and to sole proprietors. The choice between a TOV and a FOP depends on the scale of your plans and questions of liability.
For a pharmacy in a city, the sales floor must be at least 18 m²; for a pharmacy in a village, the total area must be at least 18 m² with a sales zone of at least 6 m²; a pharmacy point must be at least 10 m². The norms should be checked against the current wording of the Licensing Conditions.
Yes, and this is the key feature. The presence and conformity of the material and technical base and the qualifications of the staff are checked at each place of business before the licence is issued.
Yes. Single-tax payers who sell medicines for cash are required to use an RRO or a software RRO regardless of the group.
Submit to the State Service on Medicines the information on the absence of control by residents of the aggressor state (Annex 29) and the information on the accessibility of the premises (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 checked at each place of business before the licence is issued.
Yes. Single-tax payers who sell medicines for cash are required to use an RRO or a software RRO regardless of the group.
Submit to the State Service on Medicines the information on the absence of control by residents of the aggressor state (Annex 29) and the information on the accessibility of the premises (Annex 30) — this is required by Resolution No. 275.
Yes, through a pharmacy or pharmacy point in compliance with the Licensing Conditions and the electronic commerce legislation. But narcotic, psychotropic, potent, poisonous products and those requiring special storage conditions are not sold at a distance.
Ready to open a pharmacy?
The Dextra Law team will take your pharmacy through the entire path — from checking the premises to the entry in the licensing register — and, if you already operate, will help you meet the new 2026 requirements on time. Contact us and we will draw up a clear action plan with deadlines for your project.
