The Ministry of Health of Ukraine, together with the State Expert Center, is launching a test period for submitting registration dossier materials for medicinal products in the form of an electronic common technical document (eCTD) for the state registration of medicinal products.
This was announced during an online meeting with representatives of the pharmaceutical market on 10 May by Deputy Minister of Health for Digital Development, Digital Transformation and Digitalization Mariia Karchevych. She called on applicants to register to participate in the test period and to begin the procedure of submitting registration materials.
In accordance with MoH order No. 588 of 08.04.2024 “On Amendment to the Order of the Ministry of Health of Ukraine of 13 October 2023 No. 1789,” the test period begins and will be in effect during the following dates:
- from May until the end of 2024 – for materials submitted under the procedure of state registration of medicinal products;
- from July until the end of 2024 – for materials submitted under the procedures for state re-registration of medicinal products and amendments to registration materials during the validity of the registration certificate.
Applicants who wish to take part in the test period must notify the MoH and the Center of this by an official letter to the e-mail addresses digital@moz.gov.ua and dec@dec.gov.ua, specifying:
- the date from which you are ready to join the test period;
- the registration procedure or procedures under which submission is planned during the test period;
- contact person.
On the occasion of the start of the test period, specialists of the State Expert Center gave a presentation of the applicant's electronic cabinet and explained how to properly submit dossier materials. They demonstrated, using an example, the process of uploading an eCTD dossier through the applicant's cabinet to the Unified Information Automated System UIAS for eCTD, and answered all clarifying questions.
According to Artem Klieb, Head of the Information Technology Department of the State Expert Center, all the necessary legal and technical framework for starting the eCTD test period is currently in place. Thus, in accordance with order of the Ministry of Health No. 691 of 23.04.2024, the Specification of Module 1 in Ukraine and the Validation Criteria were approved, and the software of the EIAS for working with eCTD (applicant's cabinet, pharma decisions, electronic archive) was updated.
On the official website of the Center, in the “For applicants” section, the information required for participation in the test period and for the preparation and submission of eCTD has been updated. Answers for applicants to the most frequently asked questions have been published.
You can read the materials at the link https://www.dec.gov.ua/speczyfikkacziya-ua-m1-ectd/
It was emphasized that in the event of technical errors when submitting documents in eCTD, and in order to meet the deadlines for registration procedures, applicants will be given the opportunity to submit documents in electronic form until the errors are identified and eliminated.
If technical support or consultations are needed, applicants may contact the Technical and Software Support Division of the Center at the e-mail address ectd@dec.gov.ua
