The Ministry of Health of Ukraine, together with the State Expert Center, introduced the possibility of submitting applications for state registration (re-registration) of medicinal products, as well as making changes to registration materials in electronic form through the Single Window of the Ministry of Health. About this informs press office of the Ministry of Health.
The initiative is part of the process of digitalization and optimization of the procedure for submitting registration documents, in particular in the eCTD format. The procedure for submitting an electronic application involves several stages. First, the applicant creates a PDF file of the application and signs it with a qualified electronic signature (QES).
Next, it is necessary to log in to the applicant’s electronic account, the template of the letter for obtaining access is posted on the website of the DEC. After that, the applicant fills out a short electronic form in his personal account, adds a PDF file of the application, signed by the KEP, and a scanned copy of the power of attorney. The application is then sent to the Single Window.
After receiving the documents, they are checked in the Single Window of the Ministry of Health. If comments are found, the application is returned to the applicant for revision. If there are no comments, a referral is made and sent to the Ministry of Health for approval.
After approval of the documents by the Ministry of Health, the State Expert Center registers referrals. Applicants can check the status of registration on the website of the DEC in the section “To applicants – Checking the receipt of referrals”.
Currently, the electronic filing system covers applications for registration, re-registration and amendment procedures, including the correction of technical errors. Further plans include expanding the functionality to handle other types of applications, in particular for clinical trials.
