The EBA Нealth Сare committee manager joined the conference “Pharma Budget 2025”

30/ 09/ 2024

Last week, the Health Сare Committee Manager of the European Business Association, Olena Sytenok, participated in a panel discussion at the PHARMBUDGET 2025 conference, where she raised several pressing issues important to Ukraines pharmaceutical industry. In particular, she addressed the automatic recognition of GMP certificates issued by authorized bodies from countries with stringent regulatory authorities. Olena once again emphasized the importance of avoiding unnecessary procedures for providing conclusions and duplicating processes that complicate and delay the delivery of medicines to patients, the quality of which has already been verified by relevant institutions in the European Union. This issue has gained even more significance since Ukraine received EU candidate status, as no such procedure exists in the EU, and Ukraine needs to gradually align its legislation with EU standards. The additional recognition of GMP certificates in Ukraine should be abandoned now to harmonize Ukrainian legislation with European norms and avoid future extensive documentation changes. Moreover, the Law of Ukraine On Medicinal Products from July 28, 2022, does not provide for such conclusions. The Health Care Committee of the EBA has developed and submitted a draft procedure regarding GMP to the State Service of Ukraine on Medicines, in line with the new Law of Ukraine On Medicinal Products, which already incorporates European standards. Olena expressed hope that the Committees experts contributions will be considered in the development of the corresponding procedure. The discussion also covered the transparency of the preparation of bylaws for the Law of Ukraine regarding the parallel import of medicinal products, as the Law is set to come into effect in January 2025. However, as of late September 2024, the business community has not been familiarized with any bylaw or its draft provided for by this Law. We thank the organizers, Proxima Research, for the opportunity to support dialogue between business and the government to create conditions that foster the development of the pharmaceutical industry and enhance access to medicines for the population of Ukraine.

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Last week, the Health Сare Committee Manager of the European Business Association, Olena Sytenok, participated in a panel discussion at the “PHARMBUDGET 2025” conference, where she raised several pressing issues important to Ukraine’s pharmaceutical industry.

In particular, she addressed the automatic recognition of GMP certificates issued by authorized bodies from countries with stringent regulatory authorities. Olena once again emphasized the importance of avoiding unnecessary procedures for providing conclusions and duplicating processes that complicate and delay the delivery of medicines to patients, the quality of which has already been verified by relevant institutions in the European Union. This issue has gained even more significance since Ukraine received EU candidate status, as no such procedure exists in the EU, and Ukraine needs to gradually align its legislation with EU standards. The additional recognition of GMP certificates in Ukraine should be abandoned now to harmonize Ukrainian legislation with European norms and avoid future extensive documentation changes. Moreover, the Law of Ukraine “On Medicinal Products” from July 28, 2022, does not provide for such conclusions. The Health Care Committee of the EBA has developed and submitted a draft procedure regarding GMP to the State Service of Ukraine on Medicines, in line with the new Law of Ukraine “On Medicinal Products,” which already incorporates European standards. Olena expressed hope that the Committee’s experts’ contributions will be considered in the development of the corresponding procedure.

The discussion also covered the transparency of the preparation of bylaws for the Law of Ukraine regarding the parallel import of medicinal products, as the Law is set to come into effect in January 2025. However, as of late September 2024, the business community has not been familiarized with any bylaw or its draft provided for by this Law.

We thank the organizers, Proxima Research, for the opportunity to support dialogue between business and the government to create conditions that foster the development of the pharmaceutical industry and enhance access to medicines for the population of Ukraine.