G/TBT/N/UKR/381

14 April 2026

(26-2887)

Committee on Technical Barriers to Trade

Original: English

2.

Agency responsible:

Ministry of Health of Ukraine

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Medicines, medical immunobiological products, blood products

5.

Details of notified document(s) (title, number of pages and languages, means of access): Resolution of the Cabinet of Ministers of Ukraine 377 "Certain Issues Relating to the Distribution of Medicines, Medical Immunobiological Products and Blood Products During the Period of Martial Law" of 25 March 2026; (3 page(s), in Ukrainian)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/UKR/26_02039_00_x.pdf

https://zakon.rada.gov.ua/laws/show/377-2026-%D0%BF#Text

Secretariat of the Cabinet of Ministers of Ukraine

Department of International Trade Policy

12/2 Hrushevskoho Str.

Kyiv 01008

Tel: +(38 044) 256 65 07

Email: ep@kmu.gov.ua

Website: https://www.kmu.gov.ua/

6.

Description of content: The Resolution has been developed with the aim of ensuring proper state control over the quality of medicines, medical immunobiological products and blood products manufactured and supplied to Ukraine during the period of martial law, ensuring the re-registration process of medicines, as well as preventing the risk of medicines of inadequate quality, safety and efficacy from entering the Ukrainian market.

The Resolution introduces amendments to Resolution of the Cabinet of Ministers of Ukraine of 15 January 1996 No. 73 "On approval of the Procedure for control of compliance of immunobiological products used in medical practice with state and international standards", Resolution of the Cabinet of Ministers of Ukraine of 26 May 2005 No. 376 "On approval of the Procedure for state registration (reregistration) of medicines and the fees for their state registration (reregistration)", Resolution of the Cabinet of Ministers of Ukraine No 902 "On Approval of the Procedure for State Quality Control of Medicinal Products Imported to Ukraine" of 14 September 2005 and Resolution of the Cabinet of Ministers of Ukraine No. 1446 "Some issues of state registration of medicines, vaccines or other medical immunobiological products for the treatment and/or specific prevention of acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus, subject to for emergency medical use" of 29 December 2021.

In particular, it is established that for a period of six months from the date of entry into force of this Resolution:

• applications for the re-registration of medicines, the validity of registration certificates of which expired (or expires) during the period of martial law and has been extended for one year (until 1 January 2028), shall be submitted to the Ministry of Health;

• where active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine are used in the manufacture of finished medicines, the applicant shall introduce the relevant changes to the registration dossier;

• the manufacture of finished medicines using active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine is permitted;

• the placing on the market and use of registered finished medicines manufactured and released using active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine shall be permitted until the expiry date of such medicines.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Reducing trade barriers and facilitating trade

8.

Relevant documents:

Resolution of the Cabinet of Ministers of Ukraine No. 376 "On Approval of the Procedure for State Registration (Reregistration) of Medicines and Fees for Their State Registration (Reregistration)" of 26 May 2005;

Resolution of the Cabinet of Ministers of Ukraine No 902 "On Approval of the Procedure for State Quality Control of Medicinal Products Imported to Ukraine" of 14 September 2005;

Resolution of the Cabinet of Ministers of Ukraine No. 1446 "Some issues of state registration of medicines, vaccines or other medical immunobiological products for the treatment and/or specific prevention of acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus, subject to for emergency medical use" of 29 December 2021;

Resolution of the Cabinet of Ministers of Ukraine No. 73 "On approval of the Procedure for control of compliance of immunobiological products used in medical practice with state and international standards" of 15 January 1996.

Relevant notifications:

• G/TBT/N/UKR/300

• G/TBT/N/UKR/301

• G/TBT/N/UKR/316/Add.1

• G/TBT/N/UKR/328/Add.1

• G/TBT/N/UKR/318/Rev.1

• G/TBT/N/UKR/337/Rev.1/Add.1

9.

Proposed date of adoption: 25 March 2026

Proposed date of entry into force: 1 June 2026; This Resolution shall enter into force two months after its official publication on 1 April 2026, i.e. 1 June 2026.

10.

Provision of comments

Final date for comments: 13 June 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Secretariat of the Cabinet of Ministers of Ukraine

Department of International Trade Policy

12/2 Hrushevskoho Str.

Kyiv 01008

Tel: +(38 044) 256 65 07

Email: ep@kmu.gov.ua

Website: https://www.kmu.gov.ua/