{"id":739975,"date":"2026-05-07T16:13:02","date_gmt":"2026-05-07T13:13:02","guid":{"rendered":"https:\/\/eba.com.ua\/?p=739975"},"modified":"2026-06-02T17:10:39","modified_gmt":"2026-06-02T14:10:39","slug":"vnesennya-informatsiyi-pro-importera-obgovorennya-eba-iz-dets-ta-derzhliksluzhboyu","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/vnesennya-informatsiyi-pro-importera-obgovorennya-eba-iz-dets-ta-derzhliksluzhboyu\/","title":{"rendered":"[:ua]\u0412\u043d\u0435\u0441\u0435\u043d\u043d\u044f \u0456\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u0457 \u043f\u0440\u043e \u0456\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u0430: \u043e\u0431\u0433\u043e\u0432\u043e\u0440\u0435\u043d\u043d\u044f EBA \u0437 \u0414\u0415\u0426 \u0442\u0430 \u0414\u0435\u0440\u0436\u043b\u0456\u043a\u0441\u043b\u0443\u0436\u0431\u043e\u044e[:en]Inclusion of importer information: EBA discussion with the State Expert Centre and the State Service on Medicines[:]"},"content":{"rendered":"

<\/p>\n

The Health \u0421are Committee of the European Business Association continues its active work in preparation for the implementation of the new Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX<\/a>, effective from 1 January 2027.<\/p>\n

On 1 May, a working meeting took place between the pharmaceutical business and state authorities to discuss the inclusion of importer information in marketing authorisation dossiers and the procedure for submitting relevant amendments. The regulatory side was represented by officials from the State Expert Centre of the Ministry of Health of Ukraine (SEC) and the State Service of Ukraine on Medicines and Drugs Control, including Yuliia Zarudska, Director of the Department for Quality Control of Medicines and Blood at the State Service, Olena Semenchenko, Director of the Department for the Assessment of Registration Materials at the SEC of the Ministry of Health, as well as other SEC representatives.<\/p>\n

The business community highlighted uncertainty regarding the application of paragraph 8 of Cabinet of Ministers Resolution No. 287<\/a>, which provides for the mandatory inclusion of importer information in marketing authorisation dossiers as of 1 January 2027. At the same time, Law No. 2469-IX establishes a five-year transitional period during which medicinal products registered prior to its entry into force may be placed on the market without the application of new restrictions, with documentation to be gradually brought into compliance. According to the business community, this transitional period should also cover the requirement to include importer information in registration dossiers.<\/p>\n

At present, however, compliance with Resolution No. 287 is complicated by the absence of an approved implementation mechanism. As a result, there remains uncertainty regarding the legality of importing medicinal products falling under the transitional period but lacking importer information in their registration dossiers. Businesses also expressed concerns regarding the practical implementation of these requirements under the new legislation and the potential need to re-submit amendments once the final regulatory approach is adopted.<\/p>\n

State authorities provided clarifications on the existing regulatory mechanisms, including the application of the Ministry of Health Order No. 426<\/a>, the classification of such changes as variations, requirements for supporting documentation, and specific aspects of completing registration forms.<\/p>\n

However, companies emphasised the importance of receiving an official clarification on the application of these provisions in order to minimise the risk of import disruptions and ensure the continuity of medicinal product supply.<\/p>\n

The Health \u0421are Committee of the Association thanks the regulatory authorities for initiating a substantive dialogue on this issue. Following the discussion, participants agreed to continue consultations and to hold an additional working meeting coordinated by the State Service on Medicines to further develop aligned approaches and obtain an official position on the application of the relevant requirements.<\/p>\n

<\/p>","protected":false},"excerpt":{"rendered":"

The Health \u0421are Committee of the European Business Association continues its active work in preparation for the implementation of the new Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX, effective from 1 January 2027. On 1 May, a working meeting took place between the pharmaceutical business and state authorities to discuss the inclusion of importer […]<\/p>\n","protected":false},"author":33544,"featured_media":739976,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\nInclusion of importer information: EBA discussion with the State Expert Centre and the State Service on Medicines - 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\/vnesennya-informatsiyi-pro-importera-obgovorennya-eba-iz-dets-ta-derzhliksluzhboyu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inclusion of importer information: EBA discussion with the State Expert Centre and the State Service on Medicines - European Business Association\" \/>\n<meta property=\"og:description\" content=\"The Health \u0421are Committee of the European Business Association continues its active work in preparation for the implementation of the new Law of Ukraine \u201cOn Medicinal Products\u201d No. 2469-IX, effective from 1 January 2027. 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