Regulation of the Pharmaceutical Market of Ukraine

by Olha Povaliaieva
Thursday, September 1, 2022
Regulation of the Pharmaceutical Market of Ukraine

The updated law "On medicinal products" came into force, which standardizes the Ukrainian pharmaceutical market in accordance with European requirements

The minister of health of Ukraine, Viktor Lyashko, announced an update to the law On medicinal products. Addendums and amendments to the law optimize the legislation, implement the best European practices, and harmonize the legal relationship of all participants in our country's medicinal products field.

"Preparations for Ukraine's accession to the European Union are ongoing, therefore, work on legal acts regulating the pharmaceutical industry of Ukraine is extremely urgent. The updated law On medicinal products implements the best European practices in regulating the pharmaceutical industry. At the same time, a comprehensive updating of the legislative framework is an opportunity for the regulatory system and businesses to introduce new European work practices and update and unify market rules. This will contribute to improving the availability of medicines for Ukrainians all over the world, as well as better protect their rights as consumers," Viktor Lyashko.

Updates apply to the following areas of the pharmaceutical industry:

  • Standards of development, preclinical and clinical research, conditions of pharmaceutical development and registration of a medicinal product;
  • Standards for pharmaceutical production of the drug, determining the purpose and conditions of use, quality control and all sales options (wholesale, retail, distance trade);
  • Rights and obligations of all pharmaceutical market participants;
  • Creation of bases for developing the pharmaceutical sector in Ukraine, promoting investment in this industry, and eliminating barriers to international sales of pharmaceutical products of Ukrainian production.
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