EBA HCC meeting with VRU Committee on public health, medical assistance and medical insurance regarding the Draft Law “On Medicines” No. 5547
On June 15, 2021 EBA HCC representatives held a meeting with and the Head of VRU Committee on public health, medical assistance and medical insurance Mykhaylo Radutskiy, the Chairperson of the Subcommittee on pharmacy and pharmaceutical activities Serhii Kuzminykh and the Chairman of the Subcommittee on prevention and control of oncological diseases Valeriy Zub regarding the Draft Law “On Medicines” No. 5547 of May 21, 2021. Based on meeting results it was decided to create a Working Group to develop the Draft Law “On Medicines” No. 5547, within which to analyze the proposals of HCC member companies and propose changes to the wording of the Draft Law.
WG activity is planned to be devoted to such key issues: complete transition to electronic eCTD format of the registration procedure of medicines and clinical trials; simplified procedures for medicines registration; MAH issue and proper responsibility; medicines verification system; new regulatory body; regulation and development of clinical trials in Ukraine.
EBA HCC hopes to continue a constructive dialogue to ensure the development of a balanced new version of the Law of Ukraine “On Medicines”.