Ucrania
Autoridad Centro Estatal de Expertos del Ministerio de Salud (DEC) Sitio oficial ↗
eCTD v3.2.2 · UA M1
En vigorUkraine implemented eCTD in three phases under Clause 6, Article 13 of the Law "On Medicinal Products" (2022 edition): a pilot from 1 May to 31 December 2024 (new registrations from May; re-registrations and variations from July), a dual-format transition (paper or eCTD) from 1 January to 17 August 2025, and mandatory eCTD from 18 August 2025. Technical requirements were approved by MoH Order No. 691 of 23 April 2024: Modules 2–5 fully follow ICH eCTD v3.2.2, while Module 1 is the Ukraine-specific specification (amended by Order No. 733 and Order No. 909; current edition v1.2), published with annexes, validation criteria and the ua-regional DTD/XSL package on the DEC's dedicated page. The "authenticity" (Order No. 1391) and "recognition" (Order No. 1245) procedures are outside eCTD.
Three things to watch during the transition: variations/re-registrations may still be filed on paper, but a product is locked to eCTD after its first eCTD submission; a baseline submission is recommended early to bring historical dossier content into the lifecycle; and Module 1 sections 1.0 and 1.2 require a Ukrainian qualified electronic signature (QES), which takes time to arrange.
Anuncios y novedades
Preguntas frecuentes
When did eCTD become mandatory in Ukraine?
Under Clause 6, Article 13 of the Law of Ukraine "On Medicinal Products" (2022 edition), registration dossiers must be filed in eCTD from 18 August 2025. A pilot ran from 1 May to 31 December 2024, followed by a dual-format transition (paper or eCTD) from 1 January to 17 August 2025. The "authenticity" (Order No. 1391) and "recognition" (Order No. 1245) procedures are outside eCTD.
Do variations and re-registrations also have to use eCTD?
Variations and re-registrations may still be filed on paper or in eCTD for now; however, once any submission for a given medicinal product has been made in eCTD, all subsequent procedures for that product must continue in eCTD. During the transition a baseline submission is recommended to bring previously filed dossier content into the eCTD lifecycle.
Which specification version is Ukraine eCTD based on?
Requirements for Modules 2–5 fully follow ICH eCTD v3.2.2; Module 1 follows the UA M1 specification approved by MoH Order No. 691 of 23 April 2024 (amended by Orders No. 733 and No. 909; current edition v1.2), with the technical package (ua-regional.dtd, ua-envelope.mod, ua-regional.xsl, etc.) and validation criteria published alongside. Documents in Module 1 sections 1.0 and 1.2 must be signed with a qualified electronic signature (QES). There is no official v4.0 information yet.