The Ministry of Health of Ukraine, together with the State Expert Center (the Center), has launched the second stage of the test period for re-registration of medicinal products and amendments to registration materials in the electronic common technical document (eCTD) format.
From July until the end of the current year, applicants can submit dossier materials for medicinal products in the electronic common technical document (eCTD) format to the Center under all the main procedures: state registration, re-registration, and amendments during the validity of the registration certificate.
The relevant deadlines are defined by MoH order of 08.04.2024 No. 588 “On Amendment to the Order of the Ministry of Health of Ukraine of October 13, 2023 No. 1789”.
This was discussed during the regular online meeting with representatives of relevant associations and the pharmaceutical market chaired by Deputy Minister of Health for Digital Development Mariia Karchevych. The Center was represented by specialists of the Department for Expert Evaluation of Registration Materials and the Departments of Information and Legal Support.
During the meeting, they discussed the specifics of eCTD submission in Ukraine under re-registration/variation procedures and baseline submission, and demonstrated how to work in the applicant’s electronic cabinet.
All the necessary methodological and technical groundwork for accepting registration documents from applicants in eCTD format is now in place. Testing and configuration of the unified information and analytical system (UIAS) for working with eCTD under the re-registration and amendment procedures have been successfully completed. The system supports the full life cycle of a registration dossier for medicinal products and is ready for use, ensuring optimization of application processing.
On the official website of the Center, in the section “For applicants”, all the information necessary for participation in the test period has been published, and templates of cover letters and responses to comments have been added: https://www.dec.gov.ua/speczyfikkacziya-ua-m1-ectd/
In case of technical errors when submitting documents in eCTD, and in order to meet the deadlines of registration procedures, applicants will be given the opportunity to submit documents in electronic form until the errors are eliminated.
During the meeting, a detailed presentation of the operation of the applicant’s electronic cabinet was given, and explanations were provided on how to properly submit dossier materials under re-registration and amendment procedures (of a single registration form or a package of registration forms).
Special attention was drawn to the specifics of uploading the baseline (not mandatory), additional and/or revised materials, and working Word documents in the "Working Documents" folder.
We call on pharmaceutical market representatives to participate actively in the test period!
Those wishing to participate must notify the MoH and the Center by an official letter (digital@moz.gov.ua, dec@dec.gov.ua), specifying:
- the desired date of joining the test period;
- the registration procedure or procedures under which the submission of materials is planned (registration, re-registration, variations);
- contact person.
We remind you that the eCTD test period will last until the end of the current year. From January 2025, the submission of all registration documents in eCTD format will be voluntary, and from August 2025, in accordance with the Law of Ukraine “On Medicinal Products” of 28.07.2022 No. 2469-IX, it will be mandatory.
