Newsletter on medicines, Ukraine: price declarations and eCTD

We would like to draw your attention to important changes regarding price declaration for medicinal products and the transition to the eCTD format:

1. Price Declaration for Medicinal Products in the National Price Catalogue
Please note that price declaration for medicinal products has been introduced by Law of Ukraine No. 4239 dated February 12, 2025, and the Procedures for price referencing, declaration, and creation and management of the National Price Catalogue have been approved by Resolution of the Cabinet of Ministers of Ukraine No. 439 dated April 4, 2025.

Price declaration applies to all medicinal products, except those that:

• are procured under managed access agreements;
• are included in the list of medicinal products subject to reimbursement under the national health guarantees program;
• are procured by the State Enterprise “Medical Procurement of Ukraine” under state programs;
• are radiopharmaceuticals, narcotic or psychotropic substances, medical gases, or (non-combined) medicinal products containing precursors.

The declaration process was carried out in stages from April to August 2025, starting with original medicines included in the National Essential Medicines List and concluding with non-prescription medicines not included in the list.

The Resolution allows the sale of medicinal products without price declaration until November 1, 2025, after which their circulation is prohibited.
Remaining stock released prior to declaration of maximum wholesale prices may continue to be sold at previous prices for no longer than four months from the date of the first declaration.

2. Transition to the eCTD Format for Registration Dossiers
Starting from August 18, 2025, submission of registration dossiers for new marketing authorizations will be accepted exclusively in eCTD format, except for:

• registrations under the “authenticity” procedure (MoH Order No. 1391);
• registrations under the “recognition” procedure (MoH Order No. 1245).

For variations and renewals, both paper and eCTD formats are temporarily permitted.
However, once any submission for a given medicinal product has been made in eCTD, all subsequent procedures for that product must also be in eCTD format.

MoH Order No. 691 dated April 23, 2024 (as amended) approves the specifications for the eCTD format, including requirements for Module 1 and validation criteria.
Requirements for Modules 2–5 fully comply with ICH standards.

Key Aspects of eCTD Implementation in Ukraine

• The structure of Module 1, backbone file, file naming, and other technical parameters must comply with the specification approved by MoH Order No. 691;
• Documents in sections 1.0 and 1.2 must be signed using a qualified electronic signature (QES) in accordance with Ukrainian legislation;
• National-specific documents — such as the quality control methods (MQD), package leaflet, labeling, and RMP — must be placed in the “Working Documents” folder in .docx format, outside the main eCTD structure.

During the transition to eCTD, it is recommended to perform a baseline submission to provide the regulatory authority with access to all or part of the previously submitted documentation within the eCTD lifecycle.
Such a submission should include the current materials recommended for approval by the State Expert Center (SEC).

Cratia possesses the required software and extensive experience with electronic eCTD submissions in various international markets.
We offer a full range of services for the preparation, submission, and lifecycle management of registration dossiers in eCTD format.