{"id":661614,"date":"2025-08-04T21:02:34","date_gmt":"2025-08-04T18:02:34","guid":{"rendered":"https:\/\/eba.com.ua\/?p=661614"},"modified":"2025-08-04T21:08:10","modified_gmt":"2025-08-04T18:08:10","slug":"novi-pravyla-dlya-farmatsevtychnogo-sektoru","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/novi-pravyla-dlya-farmatsevtychnogo-sektoru\/","title":{"rendered":"[:ua]\u041d\u043e\u0432\u0456 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 \u0434\u043b\u044f \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u0441\u0435\u043a\u0442\u043e\u0440\u0443[:en]Changes in Pharmaceutical Sector Regulation[:]"},"content":{"rendered":"<p><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-661615 size-large\" src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-1024x512.png\" alt=\"\" width=\"1024\" height=\"512\" srcset=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-1024x512.png 1024w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-300x150.png 300w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-768x384.png 768w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-650x325.png 650w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-800x400.png 800w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en-100x50.png 100w, https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/banner-31.07.25-en.png 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/p>\n<p style=\"font-weight: 400;\"><strong>Key changes: The government has clarified the 20% sales quota for medicinal products and tightened requirements for pharmacy chains.<\/strong><\/p>\n<p style=\"font-weight: 400;\">On September 19, 2025, Resolution of the Cabinet of Ministers of Ukraine No. 895 of July 14, 2025 (<a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/895-2025-%D0%BF#Text\">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>\n<p style=\"font-weight: 400;\">These new provisions require immediate attention, as they impose new transparency obligations, expand the scope of compliance with the <strong>20% quota<\/strong> for product sales, and introduce new rules for pharmacies.<\/p>\n<h4 style=\"font-weight: 400;\"><strong>Key amendment for manufacturers and importers: Clarification of the 20% quota<\/strong><\/h4>\n<p style=\"font-weight: 400;\">The most significant changes pertain to the practical implementation of Article 20-4 of the Law of Ukraine &#8220;On Medicinal Products,&#8221; which restricts the sale of a finished medicinal product to a single buyer (including related parties) to <strong>20% of the net revenue<\/strong> for the previous year.<\/p>\n<p><strong>1) New obligation: Transparency of cooperation terms.<\/strong><\/p>\n<p style=\"font-weight: 400;\">Manufacturers and importers are now mandated to publicly disclose the terms of sale of their products. This information must be available <strong>on the official website<\/strong> or disseminated <strong>through other channels <\/strong>of electronic communication (for example, e-mail, messengers).<\/p>\n<p style=\"font-weight: 400;\">The disclosure must include:<\/p>\n<ul>\n<li><strong>Terms of concluding agreements <\/strong>for supply of medicinal products.<\/li>\n<li><strong>The procedure and process <\/strong>for receiving, reviewing and fulfilling purchase requests.<\/li>\n<\/ul>\n<p><strong>2) The list of grounds for exceeding the 20% quota has been detailed.<\/strong><\/p>\n<p style=\"font-weight: 400;\">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:<\/p>\n<ul>\n<li><strong>There is absence of requests <\/strong>from other buyers for the relevant volume of products.<\/li>\n<li><strong>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<li>At the time the buyer exceeding the quota applies,<strong> all other counterparties&#8217; requests having already been fulfilled<\/strong>.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><strong>Important note:<\/strong> These exceptions do not constitute a blanket exemption. Sales exceeding the 20% of the quota must be conducted <strong>on equal terms<\/strong> (price, payment terms and delivery) for all buyers in similar circumstances.<\/p>\n<p style=\"font-weight: 400;\"><em>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.<\/em><\/p>\n<h4 style=\"font-weight: 400;\"><strong>New rules for pharmacy chains: Transparency and brand protection<\/strong><\/h4>\n<p style=\"font-weight: 400;\">The amendments also address the retail segment:<\/p>\n<ul>\n<li><strong>Mandatory declaration:<\/strong> Pharmacy entities must now submit information about their <strong>affiliation with a pharmacy chain<\/strong> 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.<\/li>\n<li><strong>Prohibition on &#8220;mimicry:&#8221;<\/strong> The use of trademarks, names or other intellectual property belonging to <strong>another pharmacy or chain <\/strong>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.<\/li>\n<\/ul>\n<h4 style=\"font-weight: 400;\"><strong>Our recommendations and conclusions<\/strong><\/h4>\n<p style=\"font-weight: 400;\">The revised Licensing Conditions represent a market signal of strengthen oversight concerning transparency and competition.<\/p>\n<ol>\n<li style=\"font-weight: 400;\"><strong> For manufacturers and importers: <\/strong>It is necessary to urgently <strong>review and formalize your commercial policies<\/strong>, 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.<\/li>\n<li style=\"font-weight: 400;\"><strong>For pharmacy chains: <\/strong>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.<\/li>\n<\/ol>\n<p style=\"font-weight: 400;\">The LA Law Firm team stands ready to provide comprehensive support in adapting to the new requirements, including:<\/p>\n<ul>\n<li>Audit your commercial policies and contracts.<\/li>\n<li>Assist in development of compliant disclosure procedures.<\/li>\n<li>Advising on risk mitigation associated with potential AMCU inspections.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\"><em>Should you have any queries or suggestions, feel free to contact<\/em> <strong><em>Andrii Gorbatenko<\/em><\/strong><em>, Partner and Head of Antitrust and Competition<\/em> <em>at LA Law Firm, via <a href=\"mailto:gorbatenko@l-a.com.ua\">gorbatenko@l-a.com.ua<\/a>.<\/em><\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Key changes: The government has clarified the 20% sales quota for medicinal products and tightened requirements for pharmacy chains. On September 19, 2025, Resolution of the Cabinet of Ministers of Ukraine No. 895 of July 14, 2025 (https:\/\/zakon.rada.gov.ua\/laws\/show\/895-2025-%D0%BF#Text) will come into force, introducing substantial amendments to the Licensing Conditions for manufacturers, importers and retailers of [&hellip;]<\/p>\n","protected":false},"author":4489,"featured_media":661619,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[24,23],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Changes in Pharmaceutical Sector Regulation - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/novi-pravyla-dlya-farmatsevtychnogo-sektoru\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Changes in Pharmaceutical Sector Regulation - European Business Association\" \/>\n<meta property=\"og:description\" content=\"Key changes: The government has clarified the 20% sales quota for medicinal products and tightened requirements for pharmacy chains. On September 19, 2025, Resolution of the Cabinet of Ministers of Ukraine No. 895 of July 14, 2025 (https:\/\/zakon.rada.gov.ua\/laws\/show\/895-2025-%D0%BF#Text) will come into force, introducing substantial amendments to the Licensing Conditions for manufacturers, importers and retailers of [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/eba.com.ua\/novi-pravyla-dlya-farmatsevtychnogo-sektoru\/\" \/>\n<meta property=\"og:site_name\" content=\"European Business Association\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-04T18:02:34+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-04T18:08:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/08\/LA_Law_Firm_04082025.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Katia Chaikovska\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Katia Chaikovska\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/eba.com.ua\/novi-pravyla-dlya-farmatsevtychnogo-sektoru\/\",\"url\":\"https:\/\/eba.com.ua\/novi-pravyla-dlya-farmatsevtychnogo-sektoru\/\",\"name\":\"[:ua]\u041d\u043e\u0432\u0456 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 \u0434\u043b\u044f \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u0441\u0435\u043a\u0442\u043e\u0440\u0443[:en]Changes in Pharmaceutical Sector Regulation[:] - 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