On February 12, 2025, the new Law of Ukraine No. 4239-IX was adopted, amending the legislation regarding the state registration of medicinal products and regulating several other issues in the pharmaceutical market. In particular, changes were made to the Law of Ukraine “On Medicinal Products” and other regulatory acts.
Simplified Procedure for State Registration of Medicinal Products
The Law introduces a simplified procedure for the state registration of medicinal products purchased by the state enterprise “Medical Procurements of Ukraine” (MPU). This procedure applies to medicines registered in the United Kingdom (previously – only in the USA, Switzerland, Japan, Australia, Canada, EU countries, or through the EU centralized procedure), as well as to medicinal products from the PEPFAR database, with temporary FDA approval or from WHO prequalification lists.
Key Innovations:
- Processing Speed: 7 days for verifying the authenticity of registration materials and 5 days for decision-making.
- Registration Duration: 5 years with the possibility of re-registration.
- Documentation: Clarified list of required documents and excluded technical grounds for registration refusal.
Creation of the National Price Catalogue
One of the key innovations is the creation of the National Price Catalogue, which will contain the declared price by the manufacturer or importer for all medicinal products circulating in Ukraine. The exceptions are medicines purchased by the MPU and medicines supplied under managed access agreements (MEAs).
Catalogue Features:
- Medicinal products not listed in the catalogue cannot be sold.
- A separate reference pricing mechanism for innovative products.
- The catalogue will be updated monthly.
Price and Markup Regulation
The Law establishes a maximum wholesale markup of 8% for all medicinal products included in the National Price Catalogue. Selling products at prices exceeding those listed in the catalogue (considering markups and VAT) is prohibited.
Pharmacy and Pharmacy Chain Obligations:
- Availability of medicinal products with the three lowest procurement prices listed in the catalogue.
- Prohibition of sales at prices exceeding those in the catalogue, except in cases provided by legislation.
Restrictions on Marketing and Advertising Services
The Law is supplemented with an article that establishes restrictions on marketing and advertising services in the retail sale of medicinal products. From now on, contracts for marketing, advertising, and other services related to the sale of medicines to end consumers can only be concluded directly between manufacturers and pharmacies. This excludes marketing agencies, distributors, and other intermediaries.
Purpose of Changes:
- Minimize abuses arising from marketing payments that have impacted the prices of medicinal products.
- Increase transparency and control over pricing in the pharmaceutical market.
Restrictions on the Volume of Medicinal Product Sales
The Law is supplemented with an article that requires manufacturers and importers of medicinal products to ensure equal terms for the sale of these products throughout the calendar year. The sales volume of a single product to one business entity (including related entities) cannot exceed 20% of the net revenue from its sale in the previous year within Ukraine.
Purpose of Changes:
- Prevent excessive market concentration.
- Ensure equal access to medicinal products for various market participants.
Entry into Force
The Law has not yet been signed by the President. A gradual implementation of its provisions is anticipated, with the main part coming into effect two months after publication. The Cabinet of Ministers will need to develop a series of subordinate regulatory acts to implement this law.