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Health Care

05/ 07/ 2021
  EBA HCC initiated a multilateral discussion of the Draft Law “On Medicines” At EBA HCC initiative a Round table discussion was held on July 5, 2021 devoted to the Draft Law “On Medicines”, that for the first time brought together the representatives of all major government regulators in the pharmaceutical sector and associations operating in the field of all stages of medicines circulation. In the framework of the professional discussion the following issues were discussed: elaboration of the Industry Development Strategy; construction of mechanisms for accelerated access to innovative treatment, which in the EU for member states takes place through the registration of medicines by the European Medicines Agency, and is currently implemented in Ukraine under simplified registration procedures; creation of a single regulatory body for medicines from scratch with a special status, ensuring full transparency, non-corruption and sustainability; consideration of proposals for International Technical Assistance Projects (EBRD “UMA” project, SAFEMed USAID); implementation of the Medicines Verification System according to EU principles; recognition procedure for GMP certification documents from countries with a strict regulatory environment; requirements for MAH; risk-oriented state quality control of medicines in addition to the mechanism of licensing activities; operation of the online trade of medicines, etc. EBA HCC expresses gratitude to the representatives of the VRU Committee on Public Health, Medical Assistance and Medical Insurance, Ministry of Health of Ukraine, State Service of Ukraine for Medicines and Drugs Control, SE State Expert Center of the Ministry of Health of Ukraine, American Chamber of Commerce in Ukraine, APRаD, AIPM Ukraine, APAU and PHARMUKRAINE for a professional, open discussion and readiness for further cooperation!
01/

EBA HCC initiated a multilateral discussion of the Draft Law “On Medicines

At EBA HCC initiative a Round table discussion was held on July 5, 2021 devoted to the Draft Law “On Medicines”, that for the first time brought together the representatives of all major government regulators in the pharmaceutical sector and associations operating in the field of all stages of medicines circulation.

In the framework of the professional discussion the following issues were discussed:

  • elaboration of the Industry Development Strategy;
  • construction of mechanisms for accelerated access to innovative treatment, which in the EU for member states takes place through the registration of medicines by the European Medicines Agency, and is currently implemented in Ukraine under simplified registration procedures;
  • creation of a single regulatory body for medicines “from scratch” with a special status, ensuring full transparency, non-corruption and sustainability;
  • consideration of proposals for International Technical Assistance Projects (EBRD “UMA” project, SAFEMed USAID);
  • implementation of the Medicines Verification System according to EU principles;
  • recognition procedure for GMP certification documents from countries with a strict regulatory environment;
  • requirements for MAH;
  • risk-oriented state quality control of medicines in addition to the mechanism of licensing activities;
  • operation of the online trade of medicines, etc.

EBA HCC expresses gratitude to the representatives of the VRU Committee on Public Health, Medical Assistance and Medical Insurance, Ministry of Health of Ukraine, State Service of Ukraine for Medicines and Drugs Control, SE “State Expert Center of the Ministry of Health of Ukraine”, American Chamber of Commerce in Ukraine, APRаD, AIPM Ukraine, APAU and PHARMUKRAINE for a professional, open discussion and readiness for further cooperation!

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