WTO notification · TBT
UkraineProposed measure, not in force yet
Official title
Draft Order of the Ministry of Health of Ukraine 'Certain Issues Concerning the Assessment of Registration Dossier Materials'
Ukraine notified this proposed TBT measure to the WTO on 17 June 2026. The comment period closed on 17 July 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Medicines
The comment period closed on 17 July 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/UKR/389; it can take them up with Ukraine.
Find your country's enquiry point on WTO ePing (opens in a new tab)The draft Order has been developed in accordance with the requirements of the Law of Ukraine 'On Medicines' No. 2469-IX of 28 July 2022, taking into account the relevant European Union legislation. The main objective of the draft Order is to align the procedures for medicine registration with the Law of Ukraine 'On Medicines' and to establish a unified and modern framework for the submission and assessment of registration dossier materials. The draft Order establishes new procedures for the assessment of medicine registration dossier materials in relation to: • state registration and re-registration of medicines; • indefinite extension of state registration; • submission and assessment of variations (changes) to the registration dossier during the validity of the registration. The draft Order approves: • the procedure for the assessment of registration dossier materials; • application forms for registration, re-registration and variations; • requirements for the content and scope of the registration dossier; • requirements for the submission of variations to the dossier; • requirements for the Summary of Product Characteristics, package leaflet and labeling; • templates for clinical and non-clinical study reports; • the procedure for providing scientific advice to applicants; • the procedure for determining the significance of the clinical benefit of new therapeutic indications for reference medicines registered in Ukraine; • the list of herbal substances, herbal…
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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