We would like to draw your attention to the fact that in recent months there have been significant changes in the regulation of medicinal products in Ukraine:

1. Creation of the National Price Catalog and introduction of mandatory price declaration.

On February 12, 2025, the Law of Ukraine No. 4239 was adopted, which stipulates that manufacturers, importers or holders of registration certificates are obliged to declare the manufacturer’s price in the National Catalog of Prices for Medicinal Products. In the absence of a declared price for a medicinal product in the National Price Catalog, it is prohibited to put such a product on the market.

2. Restrictions on wholesale and retail markups for medicinal products.

Law No. 4239 stipulates that the maximum supply and distribution (wholesale) markup shall not exceed 8 percent, except as otherwise provided by law. The supply and distribution markup is calculated on the price specified in the National Price Catalog, including taxes and fees. Maximum wholesale and retail markups shall be established by the Cabinet of Ministers of Ukraine.

3. Restrictions on advertising and marketing agreements, sale of medicinal products on equal terms.

Law No. 4239 stipulates that the conclusion of contracts for the provision of marketing services, promotion services and other services related to the sale of medicines at the point of sale is permitted exclusively between the manufacturer or importer of medicines and a pharmacy and/or pharmacy chain. The conclusion of agreements on advertising services (advertising) outside of retail outlets is allowed only by business entities that are not related parties. Practices, methods and actions that lead to a reduction in purchase prices, including deferral of discounts, credit notes, bonuses or other forms of reverse price adjustment, may be applied in accordance with the procedure established by the Cabinet of Ministers of Ukraine (as of the date of this news item, the procedure has not been adopted). Failure of business entities to comply with such requirements is a violation of the license conditions for the wholesale, retail trade and import of medicines.

4. Changes to the procedure for state registration of medicinal products that may be procured by a person authorized to carry out procurement in the healthcare sector.

Law No. 4239 introduces significant changes to the procedure for state registration of medicinal products that may be procured by a person authorized to carry out procurement in the healthcare sector (SE “Medzakupili Ukrainy”).

The list of medicinal products for the “authenticity” procedure (examination period is 7 working days) has been significantly expanded: products registered by the competent authority of the United Kingdom, a member state of the European Union, included in the United States President’s Emergency Plan for AIDS Relief, having a preliminary approval by the competent authority of the United States of America (Tentative Approval), or prequalified by the WHO are included.

5. Regulation of circulation, its prohibition and cancellation of registration of medicinal products with advertising information.

Law No. 4239 stipulates that the conclusion of agreements on the provision of marketing services, promotion services and other services related to the sale of medicinal products at the point of sale is allowed only between the manufacturer or importer of medicinal products and a pharmacy and/or pharmacy chain. The conclusion of agreements on advertising services (advertising) outside of retail outlets is allowed only by business entities that are not related parties. Practices, methods and actions that lead to a reduction in purchase prices, including deferral of discounts, credit notes, bonuses or other forms of reverse price adjustment, may be applied in accordance with the procedure established by the Cabinet of Ministers of Ukraine (as of the date of this news item, the procedure has not been adopted). Failure of business entities to comply with such requirements is a violation of the license conditions for the wholesale, retail trade and import of medicines.

6. Clarifications of the State Administration on Medicinal Products regarding two registration certificates and technical requirements for labeling and instructions for use.

In its letter dated 10.03.2025, the State Administration on Medicinal Products draws attention to the situation when some medicinal products have two registration certificates approved by different orders of the Ministry of Health on state registration of a medicinal product.

This is due to the fact that during the period of martial law, the validity of old registration certificates is automatically extended with the entry of information on the extension of the validity of the registration certificate for such a medicinal product in the State Register of Medicinal Products of Ukraine (according to clause 1¹ of the Procedure for State Registration (Re-registration) of Medicinal Products, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 376 dated 26.05.2005).

The State Administration of Ukraine on Medicines and Drugs Control points out that the registration materials may be amended, in particular regarding the safety or efficacy of the drug, and insufficient information or false information in the instruction for medical use or package leaflet belongs to the second class of non-compliance of medicines, which leads to the issuance of an order to ban the circulation.

In another letter dated 10.03.2025, the State Administration on Medicinal Products clarifies the requirements for the minimum font size and line spacing in instructions and labeling, the definition of Dido points and interlinearity, and recommendations for the readability of instructions for medical use and labeling.

7.Establishing the date of entry into force of the new Law on Medicinal Products (2022) and approving related legislative acts.

Law No. 4239 stipulates that the Law on Medicinal Products (2022) shall enter into force on January 1, 2027, except for certain provisions that shall enter into force on January 1, 2028, in particular:

• conducting inspections of clinical trials;
• licensing of import of investigational medicinal products;
• peculiarities of import of active substances (APIs) in terms of compliance with GMP and GDP requirements;
• registration of business entities engaged in the import, production and wholesale of APIs;
• introduction of a national system of verification of registered medicinal products.