WTO notification · TBT
UkraineProposed measure, may since have been adopted
Official title
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Procedure for State Registration (Reregistration) of Medicines'
Ukraine notified a revised version of this proposed TBT measure on 2 February 2026. The measure was first notified on 19 November 2024. The comment period closed on 3 April 2026.
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Published here:
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Medicines
The comment period closed on 3 April 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/318/Rev.1; it can take them up with Ukraine.
Find your country's enquiry point on WTO ePing (opens in a new tab)This draft Resolution of the Cabinet of Ministers of Ukraine revises the previously notified version of the Procedure for the State Registration (Re-registration) of Medicines. The revised draft has been developed by the Ministry of Health of Ukraine in accordance with the Law of Ukraine No. 2469-IX 'On Medicines' and aims to further specify and update the unified procedural framework for the state registration (reregistration) of medicines, including finished medicines and immunobiological medicines, in alignment with 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. The revision introduces mandatory electronic submission of applications and registration dossiers in accordance with the electronic Common Technical Document (eCTD) standard, clarifies procedural steps and timelines for evaluation and decision-making, the procedure for amendments to registration dossier materials, as well as grounds for refusal, suspension, cancellation or termination of state registration. The revised measure also provides for the repeal of certain previous regulatory acts governing the state registration of medicines, in order to ensure consistency with the updated legal framework.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
RevisionG/TBT/N/UKR/318/Rev.1
Comment deadline: Closed on 3 April 2026
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Procedure for State Registration (Reregistration) of Medicines'
This draft Resolution of the Cabinet of Ministers of Ukraine revises the previously notified version of the Procedure for the State Registration (Re-registration) of Medicines. The revised draft has been developed by the Ministry of Health of Ukraine in accordance with the Law of Ukraine No. 2469-IX 'On Medicines' and aims to further specify and update the unified procedural framework for the state registration (reregistration) of medicines, including finished medicines and immunobiological medicines, in alignment with 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. The revision introduces mandatory electronic submission of applications and registration dossiers in accordance with the electronic Common Technical Document (eCTD) standard, clarifies procedural steps and timelines for evaluation and decision-making, the procedure for amendments to registration dossier materials, as well as grounds for refusal, suspension, cancellation or termination of state registration. The revised measure also provides for the repeal of certain previous regulatory acts governing the state registration of medicines, in order to ensure consistency with the updated legal framework.
Regular notificationG/TBT/N/UKR/318
Comment deadline: Closed on 18 January 2025
Draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Procedure for State Registration (Reregistration) of Medicines'
The draft Resolution of the Cabinet of Ministers of Ukraine 'On Approval of the Procedure for State Registration (Reregistration) of Medicines' has been developed to establish a unified mechanism for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products. The draft Resolution proposes to approve a new Procedure for the State Registration (Reregistration) of Medicines, which provides for: - the procedure for the state registration (reregistration) of medicines, including finished medicines, immunobiological medicinal products, and medicinal products under obligations; - the mechanism for amending the registration dossier materials; - the procedure for making decisions on suspension, cancellation and termination of state registration of a medicine and decisions to refuse state registration of a medicine; - the procedure for evaluating periodically updated safety reports on medicines and making appropriate decisions; - the amount of fees for state registration (reregistration) of medicines and the cost of services for the evaluation of registration dossier materials.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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