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American Chamber of Commerce calls to include pharmaceuticals in ACAA agreement, speed up its signing

KYIV. Sept 15 (Interfax-Ukraine) – Companies and investors, united by the American Chamber of Commerce, are calling for inclusion of pharmaceutical products in the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) and expediting the signing of the document.

According to a press release by the chamber, such an appeal was adopted following the results of the round table talk "Agreement on Conformity Assessment and Acceptance of Industrial Products – a Step towards Improvement of Healthcare System Regulation in Ukraine" with the participation of business representatives, government authorities and international experts, held in Kyiv on Wednesday.

"Preparation for the ACAA signing provides for measures to adapt the legislation of Ukraine to the legislation of the European Union, in particular, medical devices, medical devices for in vitro diagnostics, active medical devices that are implanted. The Ministry of Health is currently developing technical regulations for medical devices based on the relevant EU regulations. Measures will also be taken to ensure the implementation of presidential decree No. 369/2021, which, in particular, refers to the ACAA signing," Oleksandr Komarida, First Deputy Minister of Health of Ukraine, said.

In turn, Maryna Buchma, Co-Chair of the Healthcare Committee at the American Chamber of Commerce, Director of Government Affairs at TEVA, noted that the chamber has been working on the issue of expanding the list of industries for several years in a row, according to which the ACAA agreement should be concluded, within the framework of the EU-Ukraine Association Agreement, and inclusion in the Pharmaceutical Industry Mutual Recognition Agreement.

"Over the past year, we have deepened cooperation with the Ministry of Economy, which is key in this process. We believe that the ‘industrial visa-free regime’ for the pharmaceutical sector will be an impetus for the development of domestic production and, of course, useful for international manufacturers represented in Ukraine," she said.

The importance of this step is due not only to European integration processes, but also to the need for further development of the healthcare sector, Buchma said.