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乌克兰内阁“关于批准兽药产品国家注册条例和废除乌克兰内阁某些决议”的决议草案

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世界贸易组织	G/TBT/N/UKR/375 2026-03-30 26-2499

技术性贸易壁垒	原文：英语

通报

以下通报根据TBT协定第10.6条分发

1.	通报成员: 乌克兰如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
2.	负责机构：乌克兰经济、环境和农业部
3.	通报依据条款： [X] 2.9.2 [ ] 2.10.1 [X] 5.6.2 [ ] 5.7.1 [ ] 3.2 [ ] 7.2 通报依据的条款其他：
4.	覆盖的产品：兽药产品 HS编码：30　　ICS编码：
5.	通报标题：乌克兰内阁“关于批准兽药产品国家注册条例和废除乌克兰内阁某些决议”的决议草案；语言：乌克兰语页数：179 链接网址：
6.	内容简述：该决议草案旨在规定将工业生产或通过涉及工业过程的方法生产的兽药产品投放市场的国家注册要求。决议草案规定：兽药产品国家注册程序，包括以电子形式提交申请和所需文件；审查乌克兰国家食品安全和消费者保护局的申请；决策时间表；暂停处理申请的理由；授权（指定）机构评估注册档案材料的程序、时间表和费用；就国家登记或拒绝这种登记作出决定的理由；-申请、注册档案和申请所附的其他文件、包装传单、兽药产品标签的要求；-中止、恢复和终止国家登记的条件；-在暂停处理申请的通报中规定的补救缺陷的时限。该决议草案还提议为某些条款设立过渡期，同时考虑到乌克兰“兽医和动物福利”法的相关过渡条款，特别是：不适用提交文件确认生产场所符合GMP要求的要求（至2027年7月1日）；以纸质形式提交申请和其他文件的可能性（截至2030年3月1日）；不适用关于转基因生物研究、测试和风险评估的注册档案和支持文件的要求（截至2026年9月16日），不适用确认符合注册档案中相关良好实践的要求（截至2032年7月1日）。该决议草案旨在使动物健康和福利领域的国家立法与欧盟法律保持一致。它也是根据SPS协议通知的。
7.	目标与理由：消费者信息、标签；保护人类健康或安全；保护动物或植物的生命或健康；质量要求；协调
8.	相关文件：乌克兰《兽医和动物福利法》、《行政程序法》；欧洲议会和理事会2018年12月11日关于兽药产品和废除指令2001/82/EC的第2019/6号(EU)条例。相关通知：G/TBT/N/UKR/289
9.	拟批准日期：待定拟生效日期：决议自公布之日起生效。
10.	意见反馈截止日期： 2026年5月29日；[X]距通报60天；指定处理有关通报意见的机构或当局的联系方式：乌克兰内阁秘书处国际贸易政策部12/2 M.Hrushevskogo str.kyiv 01008 电话：+(38 044)256 65 07 电子邮件：ep@kmu.gov.ua网站：https://www.kmu.gov.ua/
11.	文本可从以下机构得到： [ ] 国家通报机构 [X] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供): 国家咨询点[X] https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_02_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_05_x.pdf https://me.gov.ua/Documents/Detail/20efed90-1e32-4c8e-995e-189390213e29?lang=uk-UA&title=ProktPostanoviKabinetuMinistrivUkrainiproZatverdzhenniaPolozhenniaProDerzhavnuRestratsiiuVeterinarnikhLikarskikhZasobivTaViznanniaTakimi-SchoVtratiliChinnistDeiakikhPostanovKabinetuMinistrivUkraini 乌克兰内阁国际贸易政策部12/2 M.hrushevskogo str.kyiv 01008 电话：+(38 044)256 65 07 电子邮件：ep@kmu.gov.ua 网站：https://www.kmu.gov.ua/



	G/TBT/N/UKR/375
	30 March 2026
(26-2499)
Committee on Technical Barriers to Trade		Original: English

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

1.	Notifying Member: UKRAINE If applicable, name of local government involved (Articles 3.2 and 7.2):
2.	Agency responsible: Ministry of Economy, Environment and Agriculture 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): Veterinary medicinal products
5.	Details of notified document(s) (title, number of pages and languages, means of access): Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Regulation on State Registration of Veterinary Medicinal Products and Repealing Certain Resolutions of the Cabinet of Ministers of Ukraine"; (179 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_01733_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_01_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_02_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_03_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_01733_05_x.pdf https://me.gov.ua/Documents/Detail/20efed90-1e32-4c8e-995e-189390213e29?lang=uk-UA&title=ProktPostanoviKabinetuMinistrivUkrainiproZatverdzhenniaPolozhenniaProDerzhavnu RestratsiiuVeterinarnikhLikarskikhZasobivTaViznanniaTakimi-SchoVtratiliChinnistDeiakikhPostanovKabinetuMinistrivUkraini 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 Resolution aims to establish state registration requirements for placing veterinary medicinal products manufactured industrially or by a method involving an industrial process on the market. The draft Resolution provides for: - procedures for state registration of veterinary medicinal products, including submission of applications and the required documents in electronic form; examination of applications by the State Service of Ukraine on Food Safety and Consumer Protection; timelines for decision-making; grounds for suspending the processing of applications; procedures, timelines and fees for assessment of registration dossier materials by the authorized (designated) authority; grounds for taking a decision on the state registration or refusal of such registration; - requirements for applications, registration dossiers and other documents attached to the application, package leaflet, labelling of veterinary medicinal products; - conditions for the suspension, restoration and termination of the state registration; - time limits for remedying deficiencies specified in the notification of suspension of the application processing. The draft Resolution also proposes to establish transitional periods for certain provisions, taking into account the relevant transitional provisions of the Law of Ukraine "On Veterinary Medicine and Animal Welfare", in particular: non-application of the requirement to submit documents confirming compliance of manufacturing sites with GMP requirements of (until 1 July 2027); possibility to submit applications and other documents in paper form (until 1 March 2030); non-application of requirements for the registration dossier and supporting documents regarding the research, testing, and risk assessment of genetically modified organisms (until 16 September 2026) and non-application of requirements for confirming compliance with relevant good practices in the registration dossier (until 1 July 2032). The draft Resolution is developed to align national legislation in the field of animal health and welfare with EU law. It is also notified under the SPS Agreement.
7.	Objective and rationale, including the nature of urgent problems where applicable: Consumer information, labelling; Protection of human health or safety; Protection of animal or plant life or health; Quality requirements; Harmonization
8.	Relevant documents: Laws of Ukraine "On Veterinary Medicine and Animal Welfare", "On Administrative Procedure"; Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. Relevant notifications: G/TBT/N/UKR/289
9.	Proposed date of adoption: To be determined Proposed date of entry into force: The Resolution will enter into force on the date of its publication.
10.	Provision of comments Final date for comments: 29 May 2026 [X] 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/

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