The Center is publishing draft documents and technical files for the implementation of eCTD. The information is posted on a dedicated page of the official website of the Center in the For applicants section, subsection “Draft documents and technical files on eCTD implementation”.
The Center has currently published drafts of the following documents:
- Specification M1 for Ukraine with recommendations on submitting registration dossier materials in the eCTD electronic format (draft)
- Annexes to the M1 specification for Ukraine (draft)
- Validation criteria (draft)
- Technical files (draft)
- User guide for the electronic Applicant Cabinet (draft)
- Checksums of technical files
You can view the documents in Ukrainian and English at the link https://www.dec.gov.ua/speczyfikkacziya-ua-m1-ectd/
If you have any comments and suggestions regarding the technical files, please send them to the e-mail address ectd@dec.gov.ua by May 01, 2024.
We inform you that the draft MoH order “On Amendment to the Order of the Ministry of Health of Ukraine of 13 October 2023 No. 1789,” which provides for the introduction of a test period for the submission of the electronic common technical document (eCTD), has already passed approval by the Ministry of Digital Transformation and other relevant institutions and is currently undergoing registration with the Ministry of Justice of Ukraine. After the Order is approved, an official invitation to join the test period will be sent to market participants.
We will provide additional information about the next steps, as well as the start date of the test period.
