Ukraine Pharmaceutical Licensing

Ukraine regulates industrial manufacture, pharmacy compounding, wholesale, retail and commercial imports of non-active pharmaceutical ingredients under separate licensing requirements. Holding a pharmacy retail, wholesale or industrial manufacturing licence does not automatically confer either of the others; state registration of a product is also not a business licence.

Resolution No. 929 applies to legal entities registered under Ukrainian law, regardless of organisational or ownership form, and to individual entrepreneurs. The published rules do not give a general conclusion allowing or prohibiting foreign investment, foreign pharmaceutical qualifications or complex group control chains; the definition of an importer requires registration in Ukraine.

— Retail: retail activities of pharmacies and their structural units.

DLS is responsible for the national licensing pathway. Its official service page for 2026 states that Cabinet Resolution No. 1209 renamed DLS as the Ukrainian Medicines Agency, with operations during the transition before 1/1/2027 governed by the relevant provisions. For new projects, use the authority name, accounts and formats shown in the electronic services and licensing register on the submission date.

The Ministry of Health’s State Register of Medicinal Products is used to check registered medicines and their instructions for medical use. The DLS and its territorial bodies participate in site verification; this is not a system of separate business licences for each oblast, but a territorial inspection arrangement under national licensing conditions.

— Licensing authority: Ukrainian Medicines Agency / DLS, responsible for licensing decisions and the licensing register.

Retail is generally permitted only through pharmacies and their structural branches. Pharmacies and branches may supply finished medicinal products and medicines prepared under pharmacy conditions; procurement must be from entities holding a manufacturing, wholesale or import licence. Prescription medicines should be supplied in accordance with the Ministry of Health’s prescription rules, and the scope of non-prescription medicines should be checked against the relevant lists and product information.

Online retail is not an automatic entitlement arising from displaying products on an ordinary website. Operators must conduct business through a pharmacy/branch included on the list of online retail operators and must have a website, order-storage/dispatch area, qualified personnel, written procedures, and their own or contracted delivery arrangements capable of maintaining storage and transport conditions.

— Online delivery generally must not handle controlled medicines, potent/toxic/radioactive medicines, immunobiological products, or prescription medicines that do not meet the requirements for electronic prescriptions.

Wholesale is conducted through medicinal product warehouses/bases and covers obtaining medicinal products from licensed manufacturers or other licensed entities, their storage and transport, and supply to other licensed wholesalers, retailers, manufacturers, healthcare institutions, and others. Its recipients and quality chain differ from pharmacy retail to the public.

Wholesalers must operate a documented quality system in accordance with GDP and good storage practice, covering supplier qualification, temperature control, batch traceability, segregation, recalls, complaints, outsourcing and internal self-inspections. Medicinal products may be procured only from entities holding a manufacturing, wholesale or import licence.

— Warehouse transaction records must be retained for at least three years and include the date, product name, batch number, quantity, expiry date, and supplier/recipient information.

Industrial manufacturing includes batch production, quality control, batch release, and storage and wholesale of the manufacturer’s own products. Manufacturers must demonstrate compliance with the State Pharmacopoeia of Ukraine/applicable technical requirements and GMP harmonised with EU law, through site master files, manufacturing formulae and written procedures. The manufacturing licence has specific conditions listed by site and dosage form.

Preparation in a pharmacy is not automatically included in ordinary retail. It must be performed in the pharmacy in accordance with the scope of the relevant manufacturing activity licence and the Ministry of Health’s rules for pharmacy preparation; sales of pharmacy-prepared products are also restricted to the licensed pharmacy and its branches.

— Manufacturing premises must be divided into production, storage, quality control and auxiliary areas.

Business licences and individual professional qualifications are separate tracks. Resolution No. 929 requires retail, wholesale, manufacturing and import operations to have appropriate personnel and authorised persons; an individual’s education, pharmaceutical specialist qualifications, work experience, quality training and eligibility to practise professionally are not automatically conferred by the company obtaining a licence.

The authorised person for the retail quality system is generally required to hold a master’s degree in pharmacy, relevant specialist qualification documents, two years’ experience and quality-specific training. Warehouse managers and authorised persons in wholesale have separate qualification and experience requirements; authorised persons in manufacturing and import may hold qualifications in pharmacy or the prescribed fields of chemistry, biotechnology, engineering, chemistry or biology, and must have relevant experience and quality responsibilities.

— Personnel directly engaged in retail or preparation in a pharmacy: generally at least a junior bachelor’s degree in a pharmaceutical specialty.

All licensed activities may be carried out only at locations listed in the licence register and using the declared means of conducting business. Applicants must have the right to possess or use the relevant premises; premises for retail, wholesale, manufacturing and import are all subject to verification at each location before the licence is issued.

The minimum total area for a retail pharmacy varies by location: 50 square metres in cities, 30 square metres in towns and 18 square metres in rural areas; the customer service area and storage area must also meet the applicable subdivision requirements. The total productive area of a general wholesale warehouse must be at least 250 square metres. Import and manufacturing premises must instead be configured to meet receipt, quarantine, quality-control, storage, release and process needs; retail floor-area requirements cannot be applied mechanically.

— Retail pharmacy: temperature/humidity recording and control, storage equipment, accessibility and sanitation management.

Applications may be submitted through the DLS e-services website and tracked online, or sent by post with an inventory of enclosures. Annex 1 is used for preparation in pharmacies, wholesale and retail; Annex 2 for industrial manufacturing; and Annex 3 for imports of medicinal products other than APIs. The application must list all proposed operating locations.

A manufacturing application must include site master file documents for each location; retail and wholesale applications must include information on material and technical resources and qualified personnel; and an import application must include the importer’s dossier. Information on control relationships/trading relationships and premises accessibility must also be provided in accordance with current rules. Documents prepared by the applicant must be in the state language of Ukraine and signed, or electronically signed, by an authorised person.

— Prepare centrally: entity information, authorised signatory, each location, rights to premises/equipment, control relationships and accessibility information.

The licensing authority must decide whether to issue or refuse the licence no later than ten working days after receiving the application and enclosures. The operator may commence the authorised activities only after the decision is published and entered in the licence register on the next working day; the licence is unlimited in duration. This statutory decision period is not a commitment that actual business opening, production, import clearance or product registration will be completed within that period.

Unless the law specifies another amount, the one-off licence issuance fee is equal to one subsistence minimum for persons of working age applicable on the date the authority makes its decision. Specific figures disclosed on the official fee page for 2024 are historical information only; this guide does not present them as a fixed hryvnia amount for 2026. Verify the official amount and payment account applicable on the decision date.

— The licensing authority specifies the payment account in its decision to issue the licence.

An unlimited licence does not exempt the holder from ongoing compliance. Manufacturing must operate under GMP and a documented medicinal product quality system; wholesale must operate under GDP, good storage practice, traceability, supplier controls, recalls and self-inspections; retail must maintain storage conditions, temperature and humidity controls, authorised personnel, procurement records and emergency recall procedures.

The licensing authority may conduct pre-licensing and ongoing supervisory inspections. Licence holders must retain the application and supporting documents, rights to use premises, personnel qualifications and employment relationship records, and other relevant records. Wholesale transaction traceability records must be retained for at least three years; quality certificates and batch-release documents for imports are also subject to longer periods or periods expressly specified by regulation.

— Manufacturing: quality system, GMP, self-inspections, complaints and effective recall procedures.

Generally, changes to information in the application, its annexes and documents must be notified in writing to the licensing authority within one month starting from the day after the change occurs. New retail/wholesale/pharmacy-preparation locations, a new manufacturing location or additional dosage forms, and changes to an import location each require the relevant notification under Resolution No. 929 with supporting documents; closure of a location or reduction in the scope of manufacturing must generally be notified within ten working days.

The only expressly specified transfer of licence rights is the route for heirs following the death of an individual entrepreneur; the heir must apply for reissuance within 30 calendar days. The public rules reviewed do not provide a single automatic transfer mechanism covering all corporate share acquisitions, asset sales, mergers, divisions or changes of control.

— Changes to specific conditions, dosage forms or the list of imported medicinal products in manufacturing/import licence annexes: notification is generally required within ten working days.

Medicinal products registered in Ukraine and their instructions for medical use can be checked in the Ministry of Health’s State Register of Medicinal Products. Resolution No. 929 generally requires imports, wholesale and retail to handle only medicinal products registered in Ukraine, except where expressly provided by law. Accordingly, national product registration, business licensing and quality/release controls for each batch must be managed in parallel.

Commercial imports (excluding APIs) require a separate import licence. The import licence annex specifies locations, the list of medicinal products authorised for import and specific conditions. Importers must have an importer’s dossier, a quality system, qualified personnel and authorised persons; imported medicines should normally have the manufacturer’s batch quality certificate and may not be sold or supplied before release by the authorised person.

— Ordinary product status: verify registration details and instructions for medical use in the Ministry of Health’s State Register of Medicinal Products.