CHANGES IN PHARMACEUTICAL SECTOR REGULATION
On September 19, 2025, Resolution of the Cabinet of Ministers of Ukraine No. 895 of July 14, 2025 will come into force, introducing substantial amendments to the Licensing Conditions for manufacturers, importers and retailers of medicinal products.
These new provisions require immediate attention, as they impose new transparency obligations, expand the scope of compliance with the 20% quota for product sales, and introduce new rules for pharmacies.
Key amendment for manufacturers and importers: Clarification of the 20% quota
The most significant changes pertain to the practical implementation of Article 20-4 of the Law of Ukraine "On Medicinal Products," which restricts the sale of a finished medicinal product to a single buyer (including related parties) to 20% of the net revenue for the previous year.
1. New obligation: Transparency of cooperation terms.
Manufacturers and importers are now mandated to publicly disclose the terms of sale of their products. This information must be available on the official website or disseminated through other channels of electronic communication (for example, e-mail, messengers).
The disclosure must include:
- Terms of concluding agreements for supply of medicinal products.
- The procedure and process for receiving, reviewing and fulfilling purchase requests.
2. The list of grounds for exceeding the 20% quota has been detailed.
The Regulation shall clarify the circumstances under which a manufacturer or importer may lawfully sell more than 20% of the volume to a single buyer. This is permitted, particularly, if:
- There is absence of requests from other buyers for the relevant volume of products.
- There is an insufficient number of concluded agreements to distribute the entire volume of products (considering the requirement to have at least five distributors, as follows from the Law).
- At the time the buyer exceeding the quota applies, all other counterparties' requests having already been fulfilled.
Important note: These exceptions do not constitute a blanket exemption. Sales exceeding the 20% of the quota must be conducted on equal terms (price, payment terms and delivery) for all buyers in similar circumstances.
Although the new rules provide more clarity, they do not eliminate all potential risks. The Antimonopoly Committee of Ukraine (AMCU), guided by its Recommendations No. 3-rk on cooperation with distributors, is expected to meticulously analyze the reasons why the manufacturer did not conclude agreements with a sufficient number of distributors. It is important to have a substantiated evidence base for each decision to decline cooperation.
New rules for pharmacy chains: Transparency and brand protection
The amendments also address the retail segment:
- Mandatory declaration: Pharmacy entities must now submit information about their affiliation with a pharmacy chain to the licensing authority. This must be done either when obtaining a license or within 6 months for existing license holders, and to notify of a change in status within 10 business days.
- Prohibition on "mimicry:" The use of trademarks, names or other intellectual property belonging to another pharmacy or chain in the name of a pharmacy is expressly prohibited. An exception applies only where pharmacies are controlled by joint beneficiaries or officially belong to the same chain.
Our recommendations and conclusions
The revised Licensing Conditions represent a market signal of strengthen oversight concerning transparency and competition.
1. For manufacturers and importers: It is necessary to urgently review and formalize your commercial policies, as well as develop a procedure for their publication. It is important to be ready to justify all refusals to conclude an agreement or all sales exceeding the 20% quota.
2. For pharmacy chains: It is advisable to verify compliance of names and signs with the new requirements, as well as to ensure timely submission of chain affiliation to avoid regulatory sanctions.
The LA Law Firm team stands ready to provide comprehensive support in adapting to the new requirements, including:
- Audit your commercial policies and contracts.
- Assist in development of compliant disclosure procedures.
- Advising on risk mitigation associated with potential AMCU inspections.
Should you have any queries or suggestions, feel free to contact Andrii Gorbatenko, Partner and Head of Antitrust and Competition at LA Law Firm, via gorbatenko@l-a.com.ua.
