G/TBT/N/UKR/387

8 June 2026

(26-4188)

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

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft Order of the Ministry of Health of Ukraine "Certain Issues Related to the Importation into the Customs Territory of Ukraine, Accounting, Storage, Use, Destruction, Disposal or Exportation from the Customs Territory of Ukraine of Investigational Medicines"; (9 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_03006_00_x.pdf

https://members.wto.org/crnattachments/2026/TBT/UKR/26_03006_01_x.pdf

https://moz.gov.ua/uk/povidomlennya-pro-oprilyudnennya-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-deyaki-pitannya-shodo-vvezennya-na-mitnu-teritoriyu-ukrayini-obliku-zberigannya-vikoristannya-znishennya-utilizaciyi

Secretariat of the Cabinet of Ministers of Ukraine

Department of International Trade Policy

12/2 M. Hrushevskogo 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 draft Order has been developed in accordance with the requirements of Paragraph 20 of Article 10 of the Law of Ukraine "On Medicines" No. 2469-IX of 28 July 2022, taking into account relevant European Union legislation.

The draft Order:

1) approves the Requirements for the importation into the customs territory of Ukraine, accounting, storage, use, destruction, disposal or exportation from the customs territory of Ukraine of investigational medicines and auxiliary medicines, which shall apply to the importation in Ukraine, accounting, storage, use, destruction, disposal or exportation from Ukraine of both unregistered and registered investigational medicinal products and auxiliary medicinal products used in the course and within the framework of clinical studies (trials);

2) establishes that:

the requirement that investigational medicines (excluding active pharmaceutical ingredients (APIs)), manufactured and released by the manufacturer's qualified person for use in clinical trials in Ukraine and imported from countries that are not Member States of the European Union or members of the European Free Trade Association that are parties to the Agreement on the European Economic Area, may be imported into the customs territory of Ukraine exclusively by business entities engaged in the importation of investigational medicines, shall apply from 1 January 2028;

from the date of entry into force of this Order until 1 January 2028, investigational medicinal products imported into the customs territory of Ukraine from countries that are not Member States of the European Union or members of the European Free Trade Association that are parties to the Agreement on the European Economic Area may be imported by the sponsor or by a person authorized by the sponsor on the basis of a power of attorney and/or a contract for the importation of investigational medicinal products into the customs territory of Ukraine.

7.

Objective and rationale, including the nature of urgent problems where applicable: Quality requirements; Harmonization

8.

Relevant documents:

Law of Ukraine No. 2469-IX "On Medicines" of 28 July 2022;

Order of the Ministry of Health of Ukraine No. 184 of 16 February 2026 "Certain Issues Concerning the Procedure for Conducting Clinical Studies (Trials) of Medicines"

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use;

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;

Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections.

Relevant notifications:

• G/TBT/N/UKR/301

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: 1 January 2027; 1 January 2027; This Order shall enter into force simultaneously with the enactment of the Law of Ukraine of 28 July 2022 No. 2469-IX "On Medicines", i.e. 1 January 2027, except for paragraphs 5–8 of Section II "Importation into the Customs Territory of Ukraine of Investigational Medicinal Products, Auxiliary Medicinal Products, and Ancillary Materials" of the Requirements, approved by this Order, which shall take effect on 1 January 2028.

10.

Provision of comments

Final date for comments: 23 July 2026 (45 days from notification)

[ ] 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 M. Hrushevskogo Str.

Kyiv 01008

Tel: +(38 044) 256 65 07

Email: ep@kmu.gov.ua

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