Significant regulatory changes for medicines: national price catalogue, mark-up limitations, amendments to the registration procedure

Please note that significant changes in the regulation of medicinal products in Ukraine have taken place in recent months, including:

• The establishment of the National Price Catalogue and the introduction of mandatory price declaration,
• The imposition of limits on wholesale and retail mark-ups on medicinal products,
• Restrictions on advertising and marketing agreements, and the requirement for equal conditions in the distribution of medicinal products,
• Amendments to the procedure for state registration of medicinal products eligible for procurement by entities authorized to carry out public health procurements,
• Regulation of the circulation, prohibition, and deregistration of medicinal products containing promotional information,
• Clarifications by the State Service of Ukraine on Medicines and Drugs Control regarding dual registration certificates and technical requirements for labeling and instructions for use,
• Establishment of the effective date for the new Law of Ukraine “On Medicinal Products” (2022) and the adoption of related legislative acts.

National price catalogue, declaration of reference prices

On February 12, 2025, the Law of Ukraine No. 4239 was adopted, establishing that manufacturers, importers, or marketing authorization holders are required to declare the manufacturer’s price in the National Price Catalogue for medicinal products. If a medicinal product does not have a declared price in the National Price Catalogue, it is prohibited from being released onto the market.

The law stipulates that the initial price declaration must be submitted no later than 120 days from the date the law enters into force (according to the legislative card on the Verkhovna Rada website — March 1, 2025, meaning no later than June 30, 2025), with the following exceptions: for medicinal products included in the National List of Essential Medicines — no later than 60 days (by April 30, 2025), for prescription medicines — no later than 90 days (by May 30, 2025). 

The declared price entered into the National Price Catalogue must be in Ukrainian Hryvnia (UAH) and must not include maximum wholesale (supply and distribution) or retail (trade) mark-ups, discounts, or value-added tax (VAT).

The declared price must not exceed the price calculated as the average of the three lowest prices for the corresponding medicinal product (by INN) in the reference countries. Price referencing does not apply to original (innovative) medicinal products. The mechanism for referencing, coordination, approval, and price registration is to be established by the Cabinet of Ministers of Ukraine. The Ministry of Health is responsible for ensuring access to reference pricing data.

As of the date of this notice, a relevant Resolution of the Cabinet of Ministers (hereinafter — the Draft Resolution) has been adopted but not yet published. The Draft Resolution includes lists of medicinal products subject to and exempt from price declaration, the procedure for referencing, the price declaration procedure, as well as the forms for the Declaration Application and Register.

The Draft Resolution provides for the calculation of reference prices in UAH for finished medicinal products (by INN) that are:

• Included in the National List of Essential Medicines;
• Prescription-only medicinal products;
• Over-the-counter medicinal products.

Reference pricing does not apply to medicinal products subject to reimbursement.

According to the Draft Resolution, reference prices are not calculated for:

• Medicinal products procured under managed entry agreements;
• Original (innovative) medicinal products;
• Medicinal products for which price data are available in fewer than three reference countries*;
• Radiopharmaceuticals, narcotic and psychotropic substances, medical gases, and medicinal products (except for combination products) that contain precursors;
• Medicinal products with no analogues (based on INN, active substance composition, or dosage form)*;
• Generic or biosimilar medicinal products that contain the same INN, active substance composition, or dosage form as an original (innovative) product for which a wholesale price has already been declared in the National Price Catalogue and which is authorized for use in Ukraine*.

* Information on such medicinal products shall be included in the National Price Catalogue without an indicated reference price, with corresponding footnotes.

According to the Draft Resolution, the price of a generic or similar biological medicinal product must not exceed 60% of the price declared in the National Price Catalogue for the corresponding original (innovative) medicinal product.

The list of original (innovative) medicinal products was published on March 31, 2025, on the website of the State Expert Center (SEC) based on information provided by applicants and is updated periodically (as of the time of publication, the list includes 1,284 medicinal products). To include a medicinal product in the list, applicants must submit a table and proof of registration as an original medicinal product. It is important to note that, according to the definition, an original (innovative) medicinal product is one that was first registered in the world based on a complete dossier concerning its quality, safety, and efficacy (full registration information).

According to the Draft Resolution, the price is calculated per unit of dosage form using the arithmetic mean of prices in the reference countries. The reference countries are Poland, Slovakia, the Czech Republic, Latvia, Hungary, Moldova, Romania, and Bulgaria. For the calculation, the four lowest reference prices among all reference countries are taken into account, excluding the lowest price.

To declare a price, an Application must be submitted via the Applicant’s Electronic Cabinet to the State Expert Center of the Ministry of Health of Ukraine (SEC of the MoH of Ukraine). On April 4, 2025, the SEC published draft instructions for price declaration, and on April 7, a preliminary step-by-step guide for document submission was released. To declare a price, the following steps must be completed:

• Obtain a power of attorney from the Marketing Authorization Holder (MAH) of the medicinal product in favor of a representative who will carry out the price declaration. The representative may be a distributor, regulatory partner, or another natural or legal person. The power of attorney must be duly legalized.
• Submit the Application for price declaration through the Applicant’s Electronic Cabinet. The Application must be signed using a qualified electronic signature under Ukrainian legislation.

According to the Draft Resolution, the declaration of wholesale prices does not apply to:

• Medicinal products procured under managed entry agreements;
• Medicinal products subject to reimbursement;
• Medicinal products procured by the State Enterprise “Medical Procurement of Ukraine”;
• Radiopharmaceuticals, narcotic and psychotropic medicinal products, medical gases, and medicinal products (except combination products) containing precursors;
• Medicinal products intended for the provision of healthcare services related to specific immunoprophylaxis of infectious diseases included in the National Immunization Schedule of Ukraine.

Limitations on wholesale and retail mark-ups

Law No. 4239 establishes that the maximum wholesale (supply and distribution) markup must not exceed 8 percent, except in cases provided by legislation. The wholesale markup is applied to the price listed in the National Price Catalogue, inclusive of applicable taxes and duties. Maximum wholesale and retail mark-ups are set by the Cabinet of Ministers of Ukraine.

According to the Resolution of the Cabinet of Ministers of Ukraine No. 168 dated February 14, 2025, the following maximum wholesale and retail mark-ups have been established:

As of March 1, 2025, both scheduled and unscheduled inspections will resume to monitor compliance by business entities engaged in the wholesale and retail trade of medicinal products and medical devices with the requirements for the formation, establishment, and application of state-regulated prices.

Restrictions on advertising, marketing agreements, and equitable distribution of medicines 

Law No. 4239 stipulates that contracts for marketing services, medicinal product promotion services, and other services related to distribution at points of sale may only be concluded between the manufacturer or importer of medicinal products and a pharmacy and/or pharmacy chain. Contracts for advertising services (advertising outside of retail locations) may only be concluded by business entities that are not affiliated parties.

Practices, methods, and actions that result in price reductions — including deferred discounts, credit notes, bonuses, or other forms of retrospective price adjustments — may be applied under a procedure to be established by the Cabinet of Ministers of Ukraine (as of the time of this publication, such a procedure has not yet been adopted). Failure by business entities to comply with these requirements constitutes a violation of the licensing conditions for wholesale, retail, and import operations related to medicinal products.

According to Resolution of the Cabinet of Ministers of Ukraine No. 168, dated February 14, 2025, the provision of marketing services, medicinal product promotion services, informational services, and other services related to the distribution of medicinal products to end consumers is prohibited until the Cabinet of Ministers of Ukraine introduces a specific system for referencing wholesale prices for all medicinal products.

Law No. 4239 also stipulates that manufacturers and marketing authorization holders must distribute medicinal products under equal conditions to all distributors — with no more than 20% of the total volume of a specific medicinal product to be sold to any single entity. A manufacturer or importer may exceed the 20% threshold for a particular distributor only if other distributors have not submitted purchase requests covering the entire available volume of the product.

Simplified State Registration for the Authorized Procurement Entity

Law No. 4239 introduces significant amendments to the state registration procedure for medicinal products that may be procured by an entity authorized to carry out healthcare-related procurements (State Enterprise “Medical Procurement of Ukraine”).

Under the “authenticity” procedure (expert review period: 7 working days), the list of eligible medicinal products has been significantly expanded. It now includes products registered by the competent authority of the United Kingdom or an EU Member State, products included in the United States President’s Emergency Plan for AIDS Relief (PEPFAR), those that have received Tentative Approval by the U.S. Food and Drug Administration, and those prequalified by the World Health Organization (WHO).

For the standard registration procedure (expert review period: 30 working days), regardless of the country of manufacture, a new provision specifies that a medicinal product may be used in Ukraine for a period of five years from the date of its state registration. After this period, continued use is allowed only upon re-registration.

Relevant amendments were also introduced to the Procedure for State Registration (Re-registration) of Medicinal Products by Resolution of the Cabinet of Ministers of Ukraine No. 39 dated January 17, 2025.

Amendments regarding circulation, prohibition, and deregistration of medicinal products

Resolution of the Cabinet of Ministers of Ukraine No. 39 dated January 17, 2025, establishes that a batch of a medicinal product manufactured before the entry into force of the Law of Ukraine No. 3910-IX dated August 21, 2024, “On Amendments to the Law of Ukraine ‘On Medicinal Products’ Regarding the Labelling of Medicinal Products” (i.e., before January 18, 2025), which bears labeling that does not meet the new requirements, may still be imported into the territory of Ukraine, placed on the market, and used until its expiration date, as indicated on the packaging.

At the same time, Resolution No. 39 expands the grounds for full or temporary prohibition of use and cancellation of state registration of a medicinal product, including:

If the applicant fails to fulfill the obligation to obtain a certificate confirming compliance of manufacturing conditions with GMP requirements, particularly if the State Service of Ukraine on Medicines and Drugs Control issues a decision to refuse such certification;

In case of violations of labeling requirements related to the presence of any promotional information, or information about persons who are not the manufacturer or the applicant (marketing authorization holder), until the labeling is brought into compliance.

Clarifications from the State Service of Ukraine on Medicines and Drugs Control (SMDC)

In its letter dated March 10, 2025, the SMDC draws attention to situations in which two valid marketing authorizations exist for certain medicinal products, each approved by different orders of the Ministry of Health of Ukraine (MoH) regarding the state registration of the medicinal product. This situation arises because, during the period of martial law, the validity of previous marketing authorizations is automatically extended, with corresponding information on the extension being entered into the State Register of Medicinal Products of Ukraine (under Clause 1¹ of the Procedure for State Registration (Re-registration) of Medicinal Products, approved by Resolution of the Cabinet of Ministers of Ukraine No. 376 dated May 26, 2005).

The SMDC emphasizes that changes may be made to the registration dossier, particularly concerning the safety or efficacy of the product. A lack of sufficient information or inaccurate information in the package leaflet or instructions for medical use is classified as Class II non-compliance for medicinal products and may result in an order to prohibit distribution.

In a separate letter dated March 10, 2025, the SMDC also provides clarification on requirements for the minimum font size and line spacing in instructions and labeling, specifying Didot points sizes, and land ine height ratios (leading), and providing recommendations on the readability of the instructions for medical use and labeling.

Entry into force of the Law of Ukraine “On Medicinal Products” (2022) and adoption of related acts

Law No. 4239 establishes that the Law of Ukraine “On Medicinal Products” (2022) will enter into force on January 1, 2027, except for certain provisions, which will become effective from January 1, 2028, including:

• Inspections of clinical trials,
• Licensing of the import of investigational medicinal products,
• Requirements for the import of active pharmaceutical ingredients (APIs) concerning GMP and GDP compliance,
• Registration of business entities engaged in the importation, manufacturing, and wholesale trade of APIs,
• Introduction of a national system for the verification of registered medicinal products.

By Resolution of the Cabinet of Ministers of Ukraine (CMU) No. 287 dated March 14, 2025, the Procedure for the Importation of Medicinal Products into the Territory of Ukraine (hereinafter – Resolution No. 287) was approved. This Resolution will take effect on January 1, 2027, the same date as the entry into force of Law No. 2469. Until then, the import of medicinal products is regulated, among others, by CMU Resolution No. 902 dated September 14, 2005, “On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine.”

Resolution No. 287 defines the importation procedure for medicinal products into Ukraine by importers, parallel importers, and distributors. It applies to all medicinal products imported into Ukraine except for:

• Medicines containing, consisting of, or manufactured from human or animal cells, which are governed by special law;
• Investigational products and those intended for compassionate use;
• Unregistered medicinal products (except those brought in under the parallel import mechanism).

According to the Resolution, medicinal products may be imported by:

• Distributors or parallel importers from an EU Member State or a country of the European Free Trade Association (EFTA) that is party to the European Economic Area (EEA) Agreement;
• Importers from other countries (i.e., those not listed above).

Medicinal products manufactured and released in countries with strict regulatory authorities (SRAs) may be imported without additional laboratory quality control in Ukraine. In the case of importing active pharmaceutical ingredients (APIs) or bulk products, the importer must independently collect samples for laboratory quality testing.

Specific requirements are established for the importation of medicinal products under the parallel import mechanism, including:

• Batch certification by a Qualified Person,
• Entry of relevant data into the State Register.

The Resolution also introduces a system for informational notifications by importers or distributors to the state control authority for each batch of medicinal products placed on the market. In this context, the Qualified Person of the importer or parallel importer, or the Responsible Person of the distributor, shall be accountable for the completeness and accuracy of the data provided in the informational notice.