Ukraine launches a National Price Catalogue for medicines: expanded price regulation is now in force
As part of the broader pharmaceutical reform, Ukraine has introduced a comprehensive regulatory framework to improve the transparency and affordability of medicines. Following legislative changes adopted in February 2025, which we covered in one of our previous legal alerts, the Government approved Resolution No. 439 on 4 April 2025, detailing the mechanisms of international reference pricing, price declaration, and the operation of the National Price Catalogue.
What’s changing?
The new rules significantly expand pricing controls across the pharmaceutical supply chain — from manufacturers to pharmacies — and introduce a single national database of maximum wholesale prices.
Key features include:
Launch of the National Price Catalogue
- Maintained by the Ministry of Health, operated by the State Expert Centre
- Lists declared maximum wholesale prices for most medicines
- Publicly available and mandatory for all players on the market
- Medicines not listed may not be sold (unless exempt)
- Price declarations must be submitted in UAH, and in foreign currency for imports
- Wholesale price cap for generics and biosimilars: not more than 75% of the reference/original product
- Wholesale markup limit: 8% (with some exceptions)
- Retail markups:
▪ 10–15% for publicly procured and reimbursed medicines
▪ 10–25% for prescription (Rx) medicines
▪ Up to 35% for over-the-counter (OTC) medicines - Retailers must stock at least one of the lowest-priced INN options in each dosage/form
International reference pricing
- Now applies to essential, reimbursed, and certain Rx and OTC products
- Reference countries: Bulgaria, Czechia, Hungary, Latvia, Moldova, Poland, Romania, Slovakia
- Prices based on the average of the 2nd, 3rd and 4th lowest prices (not the lowest)
- Some exemptions apply (e.g. original or single-source products, products with <4 reference countries, Managed Entry Agreements)
- Maximum wholesale price must be declared to be listed
- Prices may be re-declared every 6 months (earlier if FX fluctuation >5%)
- MAHs of reimbursed products must ensure consistency between declared and reimbursed prices
- Specific deadlines for declaration apply depending on whether the product is on the National Essential Medicines List (NEML) or not
Transition rules
- Ongoing tenders can be completed under previous pricing
- Sales under old price conditions allowed for 4 months after new listing
Pharmaceutical companies, distributors and pharmacies must review their pricing strategies, contracts, and reimbursement policies to ensure full compliance.
The reform signals Ukraine’s shift toward EU-aligned, transparent, and digital pharmaceutical regulation.