https:\/\/zakon.rada.gov.ua\/laws\/show\/895-2025-%D0%BF#Text<\/a>) will come into force, introducing substantial amendments to the Licensing Conditions for manufacturers, importers and retailers of medicinal products.<\/p>\nThese new provisions require immediate attention, as they impose new transparency obligations, expand the scope of compliance with the 20% quota<\/strong> for product sales, and introduce new rules for pharmacies.<\/p>\nKey amendment for manufacturers and importers: Clarification of the 20% quota<\/strong><\/h4>\nThe 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<\/strong> for the previous year.<\/p>\n1) New obligation: Transparency of cooperation terms.<\/strong><\/p>\nManufacturers and importers are now mandated to publicly disclose the terms of sale of their products. This information must be available on the official website<\/strong> or disseminated through other channels <\/strong>of electronic communication (for example, e-mail, messengers).<\/p>\nThe disclosure must include:<\/p>\n
\n- Terms of concluding agreements <\/strong>for supply of medicinal products.<\/li>\n
- The procedure and process <\/strong>for receiving, reviewing and fulfilling purchase requests.<\/li>\n<\/ul>\n
2) The list of grounds for exceeding the 20% quota has been detailed.<\/strong><\/p>\nThe 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:<\/p>\n
\n- There is absence of requests <\/strong>from other buyers for the relevant volume of products.<\/li>\n
- There is an insufficient number of concluded agreements <\/strong>to distribute the entire volume of products (considering the requirement to have at least five distributors, as follows from the Law).<\/li>\n
- At the time the buyer exceeding the quota applies, all other counterparties’ requests having already been fulfilled<\/strong>.<\/li>\n<\/ul>\n
Important note:<\/strong> These exceptions do not constitute a blanket exemption. Sales exceeding the 20% of the quota must be conducted on equal terms<\/strong> (price, payment terms and delivery) for all buyers in similar circumstances.<\/p>\nAlthough 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.<\/em><\/p>\n
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