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乌克兰与药品进口和质量控制有关的法规草案

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世界贸易组织	G/TBT/N/UKR/384 2026-06-04 26-4112

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：乌克兰卫生部
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：药品 HS编码：　　ICS编码：
5.	通报标题：乌克兰内阁决议草案"与药品进口和质量控制有关的某些问题"；语言：乌克兰语页数：60 链接网址：
6.	内容简述：制定该决议草案是为了规范药品（活性药物成分除外）进口到乌克兰领土的程序、进口到乌克兰的药品的国家质量控制、在国家实验室或国家控制机构授权的实验室对药品的质量控制测试以及某些生物药品（免疫药品和源自人血或血浆的药品）的正式批量放行。该决议草案提议修改乌克兰内阁2025年3月14日第287号决议“关于批准向乌克兰领土进口药品的程序”，以建立统一的药品进口程序和对进口到乌克兰领土的药品的国家质量控制。决议草案还规定批准在国家实验室或国家管制当局授权的实验室进行的国家药品质量管制程序；某些生物药品（免疫药品和源自人血或人血浆的药品）的正式批放行程序；制定药品抽样年度方案（计划）的标准，并废除乌克兰内阁的某些决议，包括2005年9月14日“关于批准进口到乌克兰的药品国家质量控制程序”的第902号决议和2010年2月3日“药品国家质量控制的某些问题”的第260号决议。
7.	目标与理由：质量要求；协调；减少贸易壁垒，促进贸易
8.	相关文件：乌克兰2022年7月28日第2469号《药品法》；乌克兰内阁2005年9月14日第902号决议“关于批准进口到乌克兰的药品的国家质量控制程序”（经乌克兰内阁2012年8月8日第793号决议修订）；乌克兰内阁2025年3月14日第287号决议“关于批准向乌克兰境内进口药品的程序”；欧洲议会和理事会2001年11月6日关于人用药品共同体法规的第2001/83/EC号指令。相关通知：G/TBT/N/UKR/301G/TBT/N/UKR/315G/TBT/N/UKR/315/Add.1G/TBT/N/UKR/ 258G/TBT/N/UKR/310G/TBT/N/UKR/340
9.	拟批准日期：待定拟生效日期：待定；本决议应与乌克兰2022年7月28日第2469-IX号“关于药品”的法律同时生效，即2027年1月1日。但是，本决议批准的某些生物药品（免疫药品和源自人血或血浆的药品）正式批放行程序第10段第6分段应于2028年1月1日生效。
10.	意见反馈截止日期： 2026年7月4日（距通报30天）；指定处理有关通报意见的机构或当局的详细联系方式：乌克兰内阁秘书处国际贸易政策部12/2 Hrushevskoho 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): https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_01_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_02_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_03_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_05_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_06_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_07_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_08_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_09_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_10_x.pdfhttps://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_11_x.pdfhttps://moz.gov.ua/uk/gromadske-obgovorennya-proyektu-postanovi-kabinetu-ministriv-ukrayini-deyaki-pitannya-vvezennya-ta-kontrolyu-yakosti-likarskih-zasobiv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/



	G/TBT/N/UKR/384
	4 June 2026
(26-4112)
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 Health 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): Medicines
5.	Details of notified document(s) (title, number of pages and languages, means of access): Draft Resolution of the Cabinet of Ministers of Ukraine "Certain Issues Related to the Importation and Quality Control of Medicines"; (60 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_02947_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_01_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_02_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_03_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_05_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_06_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_07_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_08_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_09_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_10_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_02947_11_x.pdf https://moz.gov.ua/uk/gromadske-obgovorennya-proyektu-postanovi-kabinetu-ministriv-ukrayini-deyaki-pitannya-vvezennya-ta-kontrolyu-yakosti-likarskih-zasobiv 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 has been developed to regulate the procedures for imports of medicines (except active pharmaceutical ingredients) into the territory of Ukraine, the state quality control of medicines imported into Ukraine, quality control testing of medicines in a state laboratory or a laboratory authorised by a state control authority and the official batch release of certain biological medicines (immunological medicinal products and medicinal products derived from human blood or plasma). The draft Resolution proposes to amend the Resolution of the Cabinet of Ministers of Ukraine No. 287 of 14 March 2025 "On Approval of the Procedure for Importation of Medicines into the Territory of Ukraine" in order to establish a unified procedure for the importation of medicines and the state quality control of medicines imported into the territory of Ukraine. The draft Resolution also provides for the approval of the Procedure for State Quality Control of Medicines Conducted in a State Laboratory or a Laboratory Authorized by the State Control Authority; the Procedure for Official Batch Release of Certain Biological Medicines (Immunological Medicinal Products and Medicinal Products Derived from Human Blood or Human Plasma); the Criteria for Establishing the Annual Programme (Plan) for Sampling of Medicines and repeal certain resolutions of the Cabinet of Ministers of Ukraine, including Resolution No. 902 of 14 September 2005 "On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine" and Resolution No. 260 of 3 February 2010 "Certain Issues of State Quality Control of Medicinal Products".
7.	Objective and rationale, including the nature of urgent problems where applicable: Quality requirements; Harmonization; Reducing trade barriers and facilitating trade
8.	Relevant documents: Law of Ukraine No 2469 "On Medicines" of 28 July 2022; Resolution of the Cabinet of Ministers of Ukraine No. 902 "On approval of the Procedure for state quality control of medicines imported into Ukraine" of 14 September 2005 (as amended by the Resolution of the Cabinet of Ministers of Ukraine of 08 August 2012 No. 793); Resolution of the Cabinet of Ministers of Ukraine No. 287 "On Approval of the Procedure for Imports of Medicines into the Territory of Ukraine" of 14 March 2025; 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. Relevant notifications: G/TBT/N/UKR/301 G/TBT/N/UKR/315 G/TBT/N/UKR/315/Add.1 G/TBT/N/UKR/258 G/TBT/N/UKR/310 G/TBT/N/UKR/340
9.	Proposed date of adoption: To be determined Proposed date of entry into force: To be determined; This Resolution shall enter into force simultaneously with the enactment of the Law of Ukraine of 28 July 2022 No. 2469-IX "On Medicines", i.e. 1 January 2027. However, subparagraph 6 of paragraph 10 of the Procedure for the Official Batch Release of Certain Biological Medicines (Immunological Medicinal Products and Medicinal Products Derived from Human Blood or Plasma), approved by this Resolution, shall enter into force on January 1, 2028.
10.	Provision of comments Final date for comments: 4 July 2026 (30 days from notification) [ ] 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 Hrushevskoho Str. Kyiv 01008 Tel: +(38 044) 256 65 07 Email: ep@kmu.gov.ua Website: https://www.kmu.gov.ua/

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