A workshop “Documents Accompanying a Medicinal Product: Summary of Product Characteristics, Package Leaflet, Labeling of Medicinal Product Packaging. Alignment with EU Standards” was held at the State Expert Center of the Ministry of Health of Ukraine. The event was devoted to current changes in approaches to the informational support of medicinal products and to practical aspects of implementing the new regulatory requirements.
During the seminar, participants discussed the regulatory changes provided for by the Law of Ukraine “On Medicinal Products” No. 2469-IX, which enters into force on 1 January 2027. The seminar was conducted by the heads of the Department for Expert Evaluation of Materials on the Medical Use of Medicinal Products and Nomenclature.
Oksana Nesterova, Head of the Department for Expert Evaluation of Materials on the Medical Use of Blood Products and Vaccines, presented to the participants the new regulatory model of information support for a medicinal product.
During the seminar, among other things, the procedure for approving the summary of product characteristics was discussed. The comparative structure of the package leaflet and the summary of product characteristics, and the key differences between them, were also reviewed. Attendees’ attention was drawn to the updated list of excipients.
During the discussion, the importance of public consultation on regulatory acts currently being prepared for approval was specifically emphasized. Participants were encouraged to take part in working on the documents that will define the new model of information support for medicinal products in Ukraine.
Yuliia Tereshkovych, Head of the Department of Expert Evaluation of Materials on the Medical Use of Traditional and Other Medicinal Products, spoke about the specifics of preparing the package leaflet of a medicinal product. The presentation emphasized that the package leaflet is an important communication tool between the manufacturer, the healthcare professional and the patient, and must be written in the state language in a form understandable to the user. Particular attention was paid to the requirements for simplicity of wording, logical presentation, clear explanation of the risks of use, and the avoidance of any promotional elements in the package leaflet.
Current requirements for the labeling of the packaging of a finished medicinal product were presented by Iryna Vozniak, Head of the Division for Expert Evaluation of Medical Use Materials of Medicinal Products under the Full Dossier. During the presentation, participants learned about the key changes and rules for packaging design and the specifics of adapting medicinal product labeling to modern European approaches.
A separate block of the seminar was devoted to the rules for creating names of medicinal products and the criteria for their acceptability, developed by the State Expert Center. Head of the Directorate for Expert Evaluation of Materials on Medical Use Viktoriia Chernenko familiarized the participants with approaches to assessing the names of medicinal products, the criteria for their acceptability, and typical reasons for rejecting proposed names during expert evaluation. Attention was also drawn to the need to avoid names that may be misleading as to the composition, properties or therapeutic effect of a medicinal product.
During the seminar, participants received explanations on preparing the accompanying documentation for medicinal products in accordance with the new regulatory requirements that bring the Ukrainian regulatory system closer to European Union standards.
