A working meeting of the management with representatives of the Healthcare Committee of the European Business Association and member companies of the Association took place at the State Expert Center of the Ministry of Health of Ukraine.
The focus of the discussion was the draft Procedure prepared by the Center for bringing registration materials for medicinal products, as well as labelling and packaging, into compliance with the requirements of Law of Ukraine No. 2469-IX "On Medicinal Products".
During the meeting, the parties discussed the proposed approaches and the specifics of their practical implementation, in particular the issues that may arise for applicants when bringing registration materials, labelling and packaging into compliance with the new requirements. EBA representatives also voiced the reservations and problematic aspects that business has drawn attention to.
The meeting was attended by the Director of the State Expert Center Edem Adamanov, heads and experts of the Center's relevant structural units. The European Business Association was represented by Yevhen Kudriavets, Head of the EBA Subcommittee on Medicinal Product Registration, Anna Bezruk and Tetiana Puzhaieva, representatives of the EBA Healthcare Committee; Association member companies also joined online.
It is important for the State Expert Center that the development of approaches determining the procedure for applicants after the new Law enters into force takes place in an open professional dialogue with all stakeholders. This format makes it possible to identify in advance issues that may arise in practice and to take them into account when finalizing the document.
The State Expert Center and the European Business Association will continue the working dialogue to establish clear and practical rules that will ensure a predictable transition to the new regulatory system and continuity of procedures.
