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Meeting of the EBA Health Сare Committee with the State Expert Centre of the Ministry of Health of Ukraine

07/ 05/ 2025
  On 23 April 2025, a working meeting took place between the Health Care Committee of the European Business Association and representatives of the State Expert Centre (SEC) of the Ministry of Health of Ukraine. The discussion focused on current issues related to changes in the regulatory framework governing the registration and re-registration of medicinal products. Particular attention was paid to the new approaches in the assessment of registration dossier materials and the expected updates to procedural requirements. Topics included changes to labelling requirements in light of the implementation of Ukraine’s medicinal product verification system, a review of the preliminary assessment procedure for registration materials, and efforts to align the registration (and re-registration) process and post-registration modifications with European Union legislation. The ЕВА expresses its gratitude to the SEC leadership and experts for their constructive cooperation and openness to dialogue. As a result of the meeting, the parties agreed to maintain regular communication to ensure a shared understanding of the processes, prevent misunderstandings, and avoid delays on the part of both the state regulator and the business community. The European Business Association remains committed to fostering transparent and predictable conditions for the pharmaceutical sector in Ukraine.

On 23 April 2025, a working meeting took place between the Health Care Committee of the European Business Association and representatives of the State Expert Centre (SEC) of the Ministry of Health of Ukraine.

The discussion focused on current issues related to changes in the regulatory framework governing the registration and re-registration of medicinal products. Particular attention was paid to the new approaches in the assessment of registration dossier materials and the expected updates to procedural requirements.

Topics included changes to labelling requirements in light of the implementation of Ukraine’s medicinal product verification system, a review of the preliminary assessment procedure for registration materials, and efforts to align the registration (and re-registration) process and post-registration modifications with European Union legislation.

The ЕВА expresses its gratitude to the SEC leadership and experts for their constructive cooperation and openness to dialogue. As a result of the meeting, the parties agreed to maintain regular communication to ensure a shared understanding of the processes, prevent misunderstandings, and avoid delays on the part of both the state regulator and the business community.

The European Business Association remains committed to fostering transparent and predictable conditions for the pharmaceutical sector in Ukraine.

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