From application to registration certificate – what applicants should know and be able to do at all stages of registration of medicinal products in Ukraine.
As part of the training events program, the Center held a seminar for applicants, “Life Cycle of Registration Materials: Problem Areas and Ways to Resolve Them.”
The purpose of the training was to discuss the step-by-step algorithm of actions, typical errors, and current issues that applicants face when submitting registration materials for medicinal products to the Center – from the moment of filing the application to receiving the registration certificate.
For the first time on this topic, the organizer was the Center's Agency for Methodological and Scientific-Practical Work. According to Head of the Agency Oleksandr HUDZENKO, the preparation took into account applicants' requests, the results of surveys on the quality of work and communications of the SEC, as well as the most frequent errors in registration materials encountered by the Center's experts.
In particular, the following issues were discussed:
- requirements for the preparation and submission of applications and registration materials to the Single Window/Service Center: analysis of typical errors and ways to optimize;
- rules for completing the registration form submitted during registration/re-registration/introduction of amendments in accordance with current legislation;
- trade name of a medicinal product: criteria applied when considering the acceptance of proposed names. The presenters dwelt in detail on how to avoid confusion and substitution of concepts in the name of a medicinal product, which may affect its safety. Examples from practice were given;
- methodological approaches to preparing registration dossier materials;
- forms of the Center's interaction with applicants at all stages of medicinal product registration and obtaining the registration certificate: the "Visualization" system, the interactive chatbot "Single Window/Service Center," the Center's Telegram channel, and free online expert consultations.
Lectures were delivered by Myroslava OHLOBLINA, Director of the Department for Coordination of Expert Materials; Iryna RESHETNIAK, Acting Director of the Department for Expert Evaluation of Registration Materials; Viktoriia CHERNENKO, Head of the Directorate for Expert Evaluation of Medical Use Materials and Nomenclature; and Maryna KARDASH, Head of the Division for Expert Evaluation of Generic Medicinal Products of the Department for Expert Evaluation of Registration Materials.
31 participants took part in the seminar. The audience showed considerable activity and asked many practical questions. The offline format of the meeting helped applicants, together with the Center's specialists and other colleagues, to work through the most controversial issues that arise when preparing registration materials. For their part, the seminar speakers noted the applicants' high level of interest in cooperation and their desire to improve and to jointly raise the quality, efficacy and safety of medicinal products in Ukraine.
We hope that the information received and the recommendations provided will help applicants improve the quality of preparing and submitting registration materials and optimize interaction with the Center.
Participants can send their feedback and suggestions about the seminar they attended to the Agency's e-mail address amsw@dec.gov.ua. All of them will be taken into account when preparing the next training sessions.
We also draw the attention of applicants and all interested parties to the fact that this seminar will be held on a regular basis. We therefore encourage those interested to register now for the next one, which will take place in November (the date will be announced separately). For registration details, call 38 (044) 202-17-00 (2251).
