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The updated law “On medicines” implements the best European practices for regulating the pharmaceutical industry – Viktor Liashko

26 August 2022

The President of Ukraine has signed a draft of the new law of Ukraine “On medicines”. The law harmonizes the Ukrainian legislation regulating legal relations in the field of medicines in Ukraine with the regulatory legal acts of the European Union. It also introduces unified terminology and rules for regulating the pharmaceutical market.

“Preparations are underway for Ukraine’s accession to the European Union, so work on legal acts regulating the pharmaceutical industry of Ukraine is extremely relevant. The updated law “On medicines” implements the best European practices for regulating the pharmaceutical industry,” explains the Health minister Viktor Liashko. “At the same time, a comprehensive update of the legislative basis is an opportunity for both the regulatory system and businesses to introduce new practices of working in a European way, update and unify market rules. This will help improve the availability of medicines for Ukrainians around the world, as well as better protect their rights as consumers.”

The updated law defines:

  • conditions for creation, pharmaceutical development, preclinical research, clinical trials (studies), state registration of medicines;
  • conditions of production, production (manufacturing) in a pharmacy, purpose, application, import, wholesale and retail trade, remote trade, quality control, implementation of pharmacovigilance of medicines;
  • rights and obligations of legal entities and individuals, as well as powers of state authorities and officials in the relevant field;
  • creating conditions for the development of the pharmaceutical industry, creating a favorable investment climate, and overcoming technical barriers to international trade in medicines;

It will also:

  • improve the protection of the rights, health and interests of consumers;
  • reduce the level of corruption in the pharmaceutical market.

The law also regulates the operation of online pharmacies, because it establishes rules for remote trade of medicines to the population and supports the extraterritoriality of delivery.