On 12 March, the Center held a workshop for applicants "LIFE CYCLE OF REGISTRATION MATERIALS: PROBLEMATIC ASPECTS AND WAYS TO RESOLVE THEM". The purpose of the training was to discuss the step-by-step algorithm of actions and current issues faced by applicants in the process of submitting materials for the state registration of medicinal products to the Center – from the moment of submitting the application to receiving the registration certificate.
The course of lectures was delivered by Iryna RESHETNIAK, Acting Director of the Department of Expert Evaluation of Registration Materials; Viktoriia CHERNENKO, Head of the Directorate for Expert Evaluation of Materials on Medical Use and Nomenclature; Maryna KARDASH, Head of the Division for Expert Evaluation of Generic Medicinal Products of the Department of Expert Evaluation of Registration Materials; and Myroslava OHLOBLINA, Director of the Department for Coordination of Expert Materials. The event was led by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr HUDZENKO.
Center experts focused the attendees’ attention on the key aspects of the medicinal product registration cycle in Ukraine, legislative requirements, and typical errors in submitting applications and other registration materials. They demonstrated specific examples and discussed problematic issues.
Viktoriia CHERNENKO drew attention to the trade name of the medicinal product and the criteria used to accept proposed names. She spoke in detail about how to avoid confusion and substitution of concepts in the name of a medicinal product, which may affect its safety. She gave examples from practice.
Myroslava OHLOBLINA spoke about the start of the path of medicinal product registration at the Center, the requirements for documents, and the forms of interaction with applicants (the “Visualization” system, the interactive chatbot “Single Window/Service Center”, the Center's Telegram channel). She focused on the rules and typical mistakes in completing and submitting applications and other registration materials to the Center, and how to avoid them.
Everything you need to know about completing the registration form for a medicinal product, the procedure for conducting expert evaluation under the procedures of registration, re-registration and introduction of changes to registration materials, the concepts of full dossier, fixed combination, biosimilar, etc. – was explained in her presentation by Iryna RESHETNIAK, Acting Director of the Department of Expert Evaluation of Registration Materials. She held an interactive session with the audience, gave practical examples and answered questions.
Maryna KARDASH presented methodological approaches to compiling the materials of the registration dossier for a medicinal product. She provided an algorithm for submitting registration dossier materials for preliminary expert evaluation. Together with the audience, she analyzed examples of dossiers, their content, and errors made during completion.
Myroslava OHLOBLINA completed the training course with a presentation on the receipt of registration certificates by applicants. She drew attention to certain issues regarding the coordination of registration documents at the stage of preparing lists for orders of the Ministry of Health.
The audience highly appreciated the practicality of the course, the opportunity to discuss disputed issues with the Center's experts, and to exchange views with colleagues.
We hope that the information received and the recommendations provided will help applicants improve the quality of preparation and submission of registration materials and optimize interaction with the Center.
We remind you that the Center holds this thematic seminar on a regular basis. You can register for the next one using the contacts of the Agency 38 (044) 202-17-00 (2251).
