On July 28, 2022, the Verkhovna Rada of Ukraine adopted Draft Law #5547 “On Medicines” (Draft Law) in the second reading and as a whole.
The American Chamber of Commerce in Ukraine (Chamber) welcomes a qualitative update of the legislation in healthcare sphere, in order to adapt it to the regulation of the European Union (EU). In particular, it concerns the issues of institutionalization of the state agency for the health technology assessment, the medicines verification system, bioequivalence and the introduction of the common electronic technical document (eCTD) format.
The business community realizes further prospects for development and aspects that seek to bring the regulatory system of Ukraine, the pharmaceutical market, and mechanisms of access to medicines for patients closer to EU norms and standards. At the same time, several issues still need to be revised.
The Chamber member companies’ experts are grateful to the Parliamentary Committee on National Health, Medical Care, and Health Insurance for the fruitful cooperation, look forward to further joint work, and are ready to provide expert support on all relevant issues as well as high-quality development of relevant legal acts.