<\/p>\n
The European Business Association welcomes the amendments to Clause 31-1 of the Licensing Conditions for Conducting Economic Activities in the Manufacture of Medicinal Products, Wholesale and Retail Trade in Medicinal Products, and Import of Medicinal Products (excluding active pharmaceutical ingredients).<\/p>\n
On 26 August 2026, Resolution No. 1062 of the Cabinet of Ministers of Ukraine introduced amendments to the Licensing Conditions, simplifying requirements for the storage of medicinal products and creating more flexible conditions for ensuring the continuity of the pharmaceutical market.<\/p>\n
This issue has been an important area of the Association\u2019s advocacy work. In March 2026, the EBA addressed Viktor Liashko, Minister of Health of Ukraine, calling for the relevant amendments to the Licensing Conditions approved by Resolution No. 929 of the Cabinet of Ministers of Ukraine.<\/p>\n
The need to improve the regulatory framework was driven by practical challenges faced by the pharmaceutical business under martial law. The regulations in force at the time provided for a special temporary mechanism aimed at safeguarding medicinal products, but this mechanism was limited specifically to their storage. At the same time, there was no clear legal basis for carrying out the full range of operations and activities within the relevant licensed type of economic activity at such premises.<\/p>\n
During the war, damage to or destruction of warehouse infrastructure as a result of hostilities, or the emergence of such risks, creates a need to relocate operations to safe premises quickly. Identifying suitable warehouse facilities, formalising contractual arrangements, equipping the premises and completing the procedures required by law all take time. This, in turn, may lead to the risk of forced downtime, supply delays and shortages of medicinal products. For this reason, the business community stressed the need for a more flexible regulatory mechanism that would ensure the continuity of licensed activities and the stability of supply chains even in crisis situations.<\/p>\n
The amendments represent an important step towards addressing the needs of businesses and better reflect the realities of operating in the pharmaceutical sector under martial law. The Association thanks the Ministry of Health of Ukraine for taking the business community\u2019s position into account and for working to improve the regulatory framework.<\/p>\n
The Association will continue its constructive dialogue with public authorities and advocacy efforts to further improve the regulatory conditions necessary for the stable operation of the pharmaceutical sector and to ensure patients\u2019 access to medicinal products.<\/p>\n
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The European Business Association welcomes the amendments to Clause 31-1 of the Licensing Conditions for Conducting Economic Activities in the Manufacture of Medicinal Products, Wholesale and Retail Trade in Medicinal Products, and Import of Medicinal Products (excluding active pharmaceutical ingredients). On 26 August 2026, Resolution No. 1062 of the Cabinet of Ministers of Ukraine introduced […]<\/p>\n","protected":false},"author":33544,"featured_media":768061,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n