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EBA proposes to speed up the implementation of the new Law on Medicines

14/ 07/ 2023
  On July 11, 2023, the Health Care Committee of the European Business Association addressed the Committee of the Verkhovna Rada of Ukraine on National Health, Medical Assistance, and Medical Insurance, as well as the Ministry of Health of Ukraine, with a proposal to accelerate the implementation of the new Ukrainian Law on Medicines, Law No. 2469-IX, dated July 28, 2022. As is known, Law No. 2469-IX resulted from joint efforts by stakeholders in Ukraines pharmaceutical industry and is crucial for implementing EU regulations in the field. Its adoption coincided with the most challenging and decisive period in the existence of our state, which objectively necessitated determining the timing of its implementation, linked to the ending of the state of war. Thanks to the Armed Forces of Ukraine, and the consolidation of efforts by government bodies and society, we can confidently speak about the possibility of reforming Ukraines pharmaceutical industry and its European integration. The current provision in the Law for its implementation after 30 months from the ending of the state of war creates significant uncertainty regarding the time required to prepare changes to other regulatory acts, establish a new state control body, and prepare business operations for their implementation. Maintaining the same positions expressed during the preparation of Law No. 2469-IX for the second reading in the Verkhovna Rada of Ukraine, the EBA Committee believes that a reasonable timeframe for implementing provisions in Law No. 2469-IX is two to three years. Considering the above, the EBA proposes implementing Law No. 2469-IX from January 1, 2026, with exceptions for certain provisions that already have defined transitional periods. We are confident that such a decision would have a significant impact on providing patients in Ukraine with access to modern and effective medication treatment, provide a clear understanding of the strategic directions for the industrys development, and be a determining factor in the success of the initiative to expand the Agreement on Conformity Assessment and Acceptance of Industrial Goods (ACAA) between Ukraine and the EU in the field of medicines and overall Eurointegration.

On July 11, 2023, the Health Care Committee of the European Business Association addressed the Committee of the Verkhovna Rada of Ukraine on National Health, Medical Assistance, and Medical Insurance, as well as the Ministry of Health of Ukraine, with a proposal to accelerate the implementation of the new Ukrainian Law on Medicines, Law No. 2469-IX, dated July 28, 2022.

As is known, Law No. 2469-IX resulted from joint efforts by stakeholders in Ukraine’s pharmaceutical industry and is crucial for implementing EU regulations in the field. Its adoption coincided with the most challenging and decisive period in the existence of our state, which objectively necessitated determining the timing of its implementation, linked to the ending of the state of war. Thanks to the Armed Forces of Ukraine, and the consolidation of efforts by government bodies and society, we can confidently speak about the possibility of reforming Ukraine’s pharmaceutical industry and its European integration.

The current provision in the Law for its implementation after 30 months from the ending of the state of war creates significant uncertainty regarding the time required to prepare changes to other regulatory acts, establish a new state control body, and prepare business operations for their implementation.

Maintaining the same positions expressed during the preparation of Law No. 2469-IX for the second reading in the Verkhovna Rada of Ukraine, the EBA Committee believes that a reasonable timeframe for implementing provisions in Law No. 2469-IX is two to three years.

Considering the above, the EBA proposes implementing Law No. 2469-IX from January 1, 2026, with exceptions for certain provisions that already have defined transitional periods.

We are confident that such a decision would have a significant impact on providing patients in Ukraine with access to modern and effective medication treatment, provide a clear understanding of the strategic directions for the industry’s development, and be a determining factor in the success of the initiative to expand the Agreement on Conformity Assessment and Acceptance of Industrial Goods (ACAA) between Ukraine and the EU in the field of medicines and overall Eurointegration.

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