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EBA and the SEC discussed changes to medicinal product registration materials in line with Law No. 2469-IX

02/ 09/ 2026
  On 28 August, representatives of the European Business Associations Health Сare Committee held a working meeting with the State Expert Centre of the Ministry of Health of Ukraine (SEC). The meeting focused on the SECs draft aimed at bringing medicinal product registration materials into line with the requirements of Ukraines Law No. 2469-IX On Medicinal Products. Business community representatives raised the key concerns and problematic issues that companies may face when transitioning to the new regulatory requirements. Participants discussed the proposed approaches and specific provisions of the draft that require further work. Following the meeting, it was agreed that the Association would provide the SEC with additional amendments and proposals to the draft. Participants also agreed to hold a further working meeting to examine these in detail and jointly explore possible solutions. The Association thanks the State Expert Centre of the Ministry of Health of Ukraine for its openness to dialogue and its willingness to discuss the business communitys position during the development of the new regulation.
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On 28 August, representatives of the European Business Association’s Health Сare Committee held a working meeting with the State Expert Centre of the Ministry of Health of Ukraine (SEC).

The meeting focused on the SEC’s draft aimed at bringing medicinal product registration materials into line with the requirements of Ukraine’s Law No. 2469-IX “On Medicinal Products”.

Business community representatives raised the key concerns and problematic issues that companies may face when transitioning to the new regulatory requirements. Participants discussed the proposed approaches and specific provisions of the draft that require further work.

Following the meeting, it was agreed that the Association would provide the SEC with additional amendments and proposals to the draft. Participants also agreed to hold a further working meeting to examine these in detail and jointly explore possible solutions.

The Association thanks the State Expert Centre of the Ministry of Health of Ukraine for its openness to dialogue and its willingness to discuss the business community’s position during the development of the new regulation.

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