Ukraine expands price regulation of medicines

Following introduction by the parliament of Ukraine of amendments to the legislation on medicines in February 2025, Ukraine has significantly expanded price regulation for medicines by establishing a new National Price Catalogue that sets maximum wholesale prices for most of the medicines on the market. 

On 4 April 2025 by Resolution No. 439, the Government adopted detailed regulations on international reference pricing, declaration of maximum wholesale prices and the National Price Catalogue.

Wholesale prices for generics and biosimilars are capped at 75% of the declared maximum price of the original (i.e. reference) medicines. Pharmacies must stock at least one of the cheapest options under the international non-proprietary name (INN), form and dosage as listed in the National Price Catalogue. These changes will increase transparency on the pharmaceutical market and make medicines more affordable.

Key changes effective from March to April 2025:

• New price mark-ups:
  • Wholesale markups are capped at 8% (some narrow exceptions apply).
  • Retail markups range from 10% to 35%, depending on how and where a medicine is sold. (For publicly procured or reimbursed medicines, the retail mark-up will remain in the range of 10% to 15%, prescription (Rx) medicines will be 10% to 25%, and over-the-counter (OTC) – 35%).
• National Price Catalogue launched:
  • The catalogue is maintained by the Ministry of Health (MOH) and administered by the State Expert Centre of MOH.
  •  The catalogue is publicly available and will include declared prices for a wide list of medicines.
  • Medicines not listed in the catalogue cannot be sold, unless specifically exempted.
  • Selling above registered prices is prohibited.
  • Declaration of maximum wholesale prices is the precondition for listing in the catalogue.
  • The prices in the catalogue may be re-declared every 6 months, unless specific exemptions apply. A selected foreign exchange rate fluctuation of over 5% constitutes ground for re-declaration by the MAH for imported medicines.
• Reference pricing expanded:
  • Reference pricing now covers not only essential and reimbursed medicines, but also certain Rx and OTC drugs.
  • Bulgaria, Czechia, Hungary, Latvia, Moldova, Poland, Romania and Slovakia are defined as the reference countries. 
  • Prices are based on the average of the second, third and fourth lowest (excluding the first lowest) in the reference countries.
  • Some medicines are exempt, including original (regardless of patent status), other single-source medicines, generics and biosimilars with the reference product available on the market, medicines with prices registered in less than 4 reference countries, Managed Entry Agreements etc.
• Price declaration rules:
  • Most medicines must now have declared maximum wholesale prices in the catalogue in the local currency (UAH). Prices for imported medicines are listed in the catalogue in UAH along with the selected foreign currency.
  • Generics and biosimilars must be no more than 75% of the reference medicine’s price.
  • If a medicine is commercialised through centralised public procurement or the outpatient reimbursement programme Affordable Medicines, and also through private retail, its price will be listed in the catalogue.
  • For out-of-pocket or public procurement sales, MAHs of medicines that are also eligible for reimbursement under the Affordable Medicines outpatient reimbursement programme must declare prices that do not exceed the reimbursed prices.
  • MAHs for original medicines listed in the National Essential Medicines List (NEML) must declare prices by 27 April, and for those not listed in the NEML – by 7 May.
• Transition period:
  • Purchasers may complete public tenders launched prior to the listing of the respective prices in the catalogue under the previous pricing rules.
  •  Wholesalers and retailers may continue to sell medicines purchased as of the date the maximum wholesale price is listed in the catalogue under the previous rules, but for no longer than four months following the listing.

What this means for the industry: 

Pharma companies, distributors, and pharmacies must adjust pricing practices to comply with the new rules. Medicines not properly declared or priced above the permitted level are at risk of being banned from sale. Companies should also monitor upcoming restrictions on marketing payments and retroactive price changes.

For further information and guidance on the National Price Catalogue and Ukraine’s health care sector, contact your CMS client partner or CMS expert Borys Danevych, Partner and Head of Life Sciences & Healthcare at CMS Ukraine, Mykhailo Sus, Senior Associate, or Volodymyr Omelchenko, Associate.