What the official information on a medicinal product submitted for expert evaluation to the Center should look like was discussed at the workshop held at the Center on April 2, 2024.
The purpose of the training is to improve applicants' awareness of national and European sectoral legislation and to discuss procedural issues and problems related to the preparation of registration materials.
The speakers were specialists of the Directorate for Expert Evaluation of Materials on Medical Use of Medicinal Products and Nomenclature of the Department of Registration Materials Expert Evaluation (DREM) of the Center, headed by the Head of the Directorate Viktoriia Chernenko. The training was organized by the Agency for Methodological and Scientific-Practical Work of the Center.
Their experience and knowledge were shared by employees of the department for expert evaluation of materials on the medical use of medicinal products under the full dossier, Hanna Soldatenko, Oksana Kryvoruk, and Olha Omelchenko; the department for expert evaluation of materials on the medical use of generic medicinal products, Iryna Shumna and Iryna Vozniak; the department for expert evaluation on the medical use of traditional and other medicinal products, Yuliia Tereshkovych and Oksana Nesterova; and the Head of the Department for Expert Evaluation of Materials on the Medical Use of Medicinal Products and Nomenclature of DERM, Viktoriia Chernenko.
Hanna Soldatenko addressed the general requirements for the instructions for medical use of a medicinal product and drew attention to the specifics of presenting information in individual sections of the instructions, illustrating the theoretical material with clear examples.
Oksana Kryvoruk presented the general requirements for the summary of product characteristics. The report focused on comparing the requirements set out in Annex 22 to the Procedure with the provisions of the EMA Guideline on summary of product characteristics 2009, in terms of adapting domestic legislation to European Union legislation.
Iryna Vozniak reviewed the requirements for the text of labeling on primary and secondary packaging, focusing on the specifics of preparing labeling for different types of medicinal products, and summarized the errors made when drawing up the labeling text. Particular attention was paid to the requirements for applying labeling in Braille, provided for people with visual impairments.
Olha Omelchenko addressed typical lexical and grammatical errors in the texts of instructions. The speaker drew the attention of those present to the importance of observing the norms and rules of Ukrainian orthography and clearly showed what negative consequences neglecting them can lead to.
Oksana Nesterova outlined the regulatory requirements for the registration dossier during the registration of medicinal products with well-established medical use, emphasized the specifics of demonstrating the efficacy and safety of medicinal products, and identified the factors to be taken into account when choosing the type of application. She also drew attention to errors that applicants often make in the registration dossier.
Yuliia Tereshkovych acquainted the seminar participants with the special requirements for registration dossier materials for traditional medicinal products, emphasizing the adaptation of these requirements to European Union legislation. Typical errors in drafting the draft instructions for medical use of traditional medicinal products were analyzed.
Iryna Shumna considered the specifics of the expert evaluation of registration dossier materials when introducing changes. Referring to the classification of changes under the current legislation, the speaker specified the types of changes and the criteria for determining a technical error.
Viktoriia Chernenko raised the issue of the ban on advertising of medicinal products and reviewed the updated criteria for the advertising ban defined by MoH of Ukraine order No. 422, as amended.
During the discussion, the seminar participants received practical recommendations on preparing and maintaining registration documentation. The Directorate's openness to dialogue and cooperation with applicants, and its readiness to provide consultations and answers to problematic issues, were emphasized.
To improve work efficiency, applicants are also invited to send the topics that interest them for further coverage. This can be done by e-mail to the Agency for Methodological and Scientific-Practical Work of the Center amsw@dec.gov.ua
