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UA M1 eCTD Specification

Approved documents on the implementation of eCTD in Ukraine
To receive technical support, you can send your questions to the email ectd@dec.gov.ua

Answers to the most frequently asked questions about eCTD (F.A.Q.)

Order of the Ministry of Health of Ukraine dated 23.04.2024 No. 691

Order of the Ministry of Health of Ukraine dated 29.04.2024 No. 733

Order of the Ministry of Health of Ukraine dated 08.04.2024 No. 588

Order of the Ministry of Health of Ukraine dated 29.05.2024 No. 909

  UA M1 v1.2
Specification V1.2 Download
Annexes Download
Validation criteria Download
DTD Download
User guide for the applicant's electronic cabinet Download
Templates  
eCTD cover letter Download
Template of responses to comments Download
Template of a letter in case of technical
problems
Download
Template of a letter requesting access to the Applicant's Cabinet (registration procedures)  Download
Template of a letter requesting access to the Applicant's Cabinet (QC, SP) Download
Checksum  
ua-regional.dtd 2490411d203beb65034aa9808153e633
ua-envelope.mod 883578d24b17f7185c0ee177573df22b
ua-leaf.mod 03bdb97b4b9ab4108356ac033cbe594a
ua-regional.xsl 0e096bc6f89a3912dfb9b09d0356a224
For reference only, previous outdated versions
Specification V1.0 Download

Requirements documents regarding the implementation of eCTD in Ukraine. email ectd@dec.gov.ua.

Answers to the most frequently asked questions eCTD (FAQ)

  UA M1 v1.2
Specification v1.2 Download
Annexes Download
Validation Criteria Download
DTD Download
User Guide for the Electronic Applicant Cabinet Download
Checksum  
ua-regional.dtd 2490411d203beb65034aa9808153e633
ua-envelope.mod 883578d24b17f7185c0ee177573df22b
ua-leaf.mod 03bdb97b4b9ab4108356ac033cbe594a
ua-regional.xsl 0e096bc6f89a3912dfb9b09d0356a224
Exclusively for familiarization, previous outdated versions
Specification V1.0 Download