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The EBA joined the discussion of amendments to the draft law №5815

03/ 10/ 2023
  The Chairman of the Clinical Trials Subcommittee Andrii Biliavskyi and the Executive Director of the Subcommittee Iryna Magdik participated in a working meeting at the Ministry of Health of Ukraine with the participation of representatives of the Verkhovna Rada, the Ministry of Health, law enforcement agencies, and scientists to discuss the provisions of Draft Law No. 5815 and formulate relevant amendments to the Criminal Code. The Subcommittees experts actively participated in the development and support of Draft Law No. 5815 in terms of improving liability for violation of the established procedure for preclinical studies, clinical trials and state registration/re-registration of medicines. The next stage of the discussion confirmed the relevance of regulating the issue of criminal liability in the clinical trials industry and the need for changes in the current legislation. We thank the Chairman of the Verkhovna Rada Committee on Law Enforcement Serhii Ionushas, MP Valerii Zub, First Deputy Minister of Health of Ukraine Serhii Dubrov, Deputy Minister of Health of Ukraine for European Integration Maryna Slobodnichenko for supporting the need for changes and for the fruitful discussion! We continue to work and hope for a quick finalization and approval of the draft law concept for its further adoption by the parliamentarians!
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The Chairman of the Clinical Trials Subcommittee Andrii Biliavskyi and the Executive Director of the Subcommittee Iryna Magdik participated in a working meeting at the Ministry of Health of Ukraine with the participation of representatives of the Verkhovna Rada, the Ministry of Health, law enforcement agencies, and scientists to discuss the provisions of Draft Law No. 5815 and formulate relevant amendments to the Criminal Code.

The Subcommittee’s experts actively participated in the development and support of Draft Law No. 5815 in terms of improving liability for violation of the established procedure for preclinical studies, clinical trials and state registration/re-registration of medicines. The next stage of the discussion confirmed the relevance of regulating the issue of criminal liability in the clinical trials industry and the need for changes in the current legislation.

We thank the Chairman of the Verkhovna Rada Committee on Law Enforcement Serhii Ionushas, MP Valerii Zub, First Deputy Minister of Health of Ukraine Serhii Dubrov, Deputy Minister of Health of Ukraine for European Integration Maryna Slobodnichenko for supporting the need for changes and for the fruitful discussion!

We continue to work and hope for a quick finalization and approval of the draft law concept for its further adoption by the parliamentarians!

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