Skip to content

WTO notification · TBT

UkraineProposed measure, may since have been adopted

Pharmaceutical products – Ukraine

Official title

Draft Order of the Ministry of Health of Ukraine 'On Approval of the Procedure for Confirming the Compliance of Medicine Manufacturing Facilities Located Outside Ukraine with the Good Manufacturing Practice Requirements Established in Ukraine'

Ukraine notified this proposed TBT measure to the WTO on 5 May 2026. The comment period closed on 19 June 2026.

Expodite puts notifications like this one in your Updates centre, matched to the HS codes of your products and the markets you export to. Opens the requirements check for Ukraine in your Expodite account.

Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

Medicines

Notifying member
Ukraine
Status
Proposed measure, may since have been adoptedNotified as a draft on 5 May 2026. Check WTO ePing or Ukraine for its current status.
Objectives
  • Quality requirements
  • Harmonization
  • Reducing trade barriers and facilitating trade
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/UKR/382
ICS classification
  • 11.120 Pharmaceutics

Key dates

Distributed by the WTO
Comment deadline
Closed on 19 June 2026
Proposed adoption
To be determined
Proposed entry into force

How to comment

The comment period closed on 19 June 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/382; it can take them up with Ukraine.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

The draft Order has been developed in accordance with the requirements of Articles 47 and 108 of the Law of Ukraine 'On Medicines' No. 2469-IX of 28 July 2022, taking into account relevant European Union legislation. In accordance with Article 47(4) of the Law, confirmation of compliance of medicine manufacturing with the Good Manufacturing Practice requirements established in Ukraine, including for manufacturing facilities located outside Ukraine, shall be carried out by the state control authority through the inspection of manufacturing facilities conducted in a manner aligned with European Union legislation, taking into account the inspection procedures and information exchange practices applied in the European Union for the manufacture and distribution of medicines, and based on a risk-based planning approach (except for imported active pharmaceutical ingredients). The draft Order establishes the legal and organisational framework for the procedure for confirming compliance of manufacturing conditions of medicines at manufacturing facilities located outside Ukraine with the Good Manufacturing Practice (GMP) requirements established in Ukraine. In particular, it provides for: the inspection of medicine manufacturing facilities located outside Ukraine; the recognition of official GMP compliance documents issued by competent authorities of countries with Stringent Regulatory Authorities (SRAs); the issuance by the state control authority of documents confirming GMP…

All updates from Ukraine
  1. WTO notificationTBTProposed measure, open for comments

    Law of Ukraine of 13 October 2026 No. 5013 'On Amendments to the Tax Code of Ukraine and Certain Other Laws of Ukraine Regarding the Postponement of the Introduction of…

    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

  2. WTO notificationSPSIn force, according to its latest notice

    The draft Order of the Ministry of Economy and Environment of Ukraine 'On Amendments to the List of food products of non-animal origin and feedstuffs of non-animal origin, the…

    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

  3. WTO notificationTBTProposed measure, open for comments

    Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of Detailed Rules for Organic Production and Circulation of Organic Products and Repeal of Certain…

    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

All export regulation updates

Get these automatically for your products and markets.

Expodite matches each notification to the markets you export to and the HS codes of your products, and puts the ones that concern you in your Updates centre, with the date comments close.