WTO notification · TBT
UkraineProposed measure, not in force yet
Official title
Order of the Ministry of Health of Ukraine No. 184 of 16 February 2026 'Certain Issues of the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products'
Ukraine notified this proposed TBT measure to the WTO on 14 October 2026.
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Published here:
Medicinal products
The notification sets no comment deadline. To comment, contact your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/UKR/417; it forwards comments to Ukraine.
Find your country's enquiry point on WTO ePing (opens in a new tab)Ukraine notifies 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 Medicinal Products'. The Order aims to eliminate regulatory barriers to conducting clinical trials in Ukraine and update the applicable procedural requirements in line with the provisions of Law of Ukraine No. 2469-IX of 28 July 2022 'On Medicines'. In particular, the Order approves the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products and the Requirements for the Form and Content of Informed Consent for Participation in Clinical Studies (Trials). The Procedure for Conducting Clinical Studies (Trials) of Medicinal Products establishes the main requirements for conducting clinical trials of medicinal products in Ukraine, including advanced therapy medicinal products, combined advanced therapy medicinal products, bioavailability and bioequivalence studies, and international multicentre clinical trials, involving patients or healthy volunteers. The Order was developed taking into account the provisions of Directive 2001/83/EC, Regulation (EU) No 536/2014, Regulation (EC) No 726/2004 and Commission Directive 2005/28/EC, including its provisions on the authorisation of the manufacture or import of investigational medicinal products, with the aim of regulating the conduct of clinical trials of medicinal products and the assessment of clinical trial documentation.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
Notified documents
WTO notificationSPSProposed measure, open for commentsNew
The draft Order proposes to approve the List of substances having a hormonal or thyrostatic action and of beta-agonists prohibited for use in stockfarming.
Symbol: G/SPS/N/UKR/284Comments until 29 December 2026
WTO notificationTBTProposed measure, open for commentsNew
The Law amends the Tax Code of Ukraine and certain other laws to postpone the introduction of the electronic traceability system of the circulation of alcoholic beverages, tobacco products and liquids used in electronic cigarettes. The Law postpones the introduction of the electronic excise stamp…
Symbol: G/TBT/N/UKR/422Comments until 27 November 2026
WTO notificationSPSIn force, according to its latest noticeNew
The draft Order proposes amendments to the List of food products of non-animal origin and feedstuffs of non-animal origin, the consignments of which are subject to enhanced state control when imported (sent) into the customs territory of Ukraine, approved by Order of the Ministry of Agrarian…
Symbol: G/SPS/N/UKR/275/Add.1
WTO notificationTBTProposed measure, open for commentsNew
The draft Resolution establishes Detailed Rules for the organic production and circulation of organic products and in-conversion products. The Rules set out requirements for various categories of organic production, including plant production, livestock production, aquaculture and the production…
Symbol: G/TBT/N/UKR/421Comments until 22 November 2026
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