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乌克兰卫生部“关于批准国际贸易药品质量认证程序和出口活性药物成分确认”的命令草案

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世界贸易组织	G/TBT/N/UKR/386 2026-06-08 26-4181

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：乌克兰卫生部“关于批准国际贸易药品质量认证程序和出口活性药物成分确认”的命令草案；语言：乌克兰语页数：30 链接网址：
6.	内容简述：该命令草案提议通过更新术语并使其与2022年7月28日“关于药品”的第2469-IX号法律保持一致，为用于国际贸易的药品质量认证程序和用于出口的活性药物成分的确认建立法律和组织框架。乌克兰卫生部2022年7月25日第1310号命令“关于批准国际贸易药品质量认证程序和出口活性药物成分确认”（在文件G/TBT/N/UKR/216和G/TBT/N/UKR/216/Add.1中通知）将被废除。该命令草案还规定，在本命令生效前已经启动但尚未完成的任何用于国际贸易的药品质量认证和用于出口的活性药物成分确认程序，应根据卫生部2022年7月25日第1310号命令批准的程序完成，为了完成此类程序，应适用自本命令生效之日起生效的版本。完成该程序后通过的任何决定应以本命令批准的形式发布。
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-IX号《药品法》欧洲议会和欧盟理事会2001年11月6日关于人用药品共同体法典的第2001/83/EC号指令相关通报： G/TBT/N/UKR/301 G/TBT/N/UKR/216 G/TBT/N/UKR/216/Add.1 G/TBT/N/UKR/282 G/TBT/N/UKR/282/Add.1
9.	拟批准日期：待定拟生效日期：2027年1月1日；该命令将与乌克兰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。
10.	意见反馈截止日期： 2026年7月23日（自通报之日起45天）负责处理与本通报相关评议意见的主管机构联系方式：乌克兰内阁秘书处国际贸易政策司地址：基辅，赫鲁舍夫斯基大街12/2号，邮编01008 电话：+(38 044) 256 65 07 电子邮箱：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_03000_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_01_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_02_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_03_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_05_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_06_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_08_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_07_x.pdf https://moz.gov.ua/uk/gromadske-obgovorennya-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-pro-zatverdzhennya-poryadku-sertifikaciyi-yakosti-likarskih-zasobiv-dlya-mizhnarodnoyi-torgivli-ta-pidtverdzhennya 乌克兰内阁秘书处国际贸易政策司地址：基辅，赫鲁舍夫斯基大街12/2号，邮编01008 电话：+(38 044) 256 65 07 电子邮箱：ep@kmu.gov.ua 网站：https://www.kmu.gov.ua/



	G/TBT/N/UKR/386
	8 June 2026
(26-4181)
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 Order of the Ministry of Health of Ukraine "On Approval of the Medicines Quality Certification Procedure for International Trade and Confirmation for Exported Active Pharmaceutical Ingredients"; (30 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_03000_00_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_01_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_02_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_03_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_04_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_05_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_06_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_08_x.pdf https://members.wto.org/crnattachments/2026/TBT/UKR/26_03000_07_x.pdf https://moz.gov.ua/uk/gromadske-obgovorennya-proyektu-nakazu-ministerstva-ohoroni-zdorov-ya-ukrayini-pro-zatverdzhennya-poryadku-sertifikaciyi-yakosti-likarskih-zasobiv-dlya-mizhnarodnoyi-torgivli-ta-pidtverdzhennya 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 Order proposes to establish the legal and organizational framework for the procedure of quality certification of medicines for international trade and confirmation of active pharmaceutical ingredients intended for export through the updating of terminology and aligning it with the Law No. 2469-IX "On Medicines" of 28 July 2022. The Order of the Ministry of Health of Ukraine of 25 July 2022 No. 1310 "On Approval of the Medicines Quality Certification Procedure for International Trade and Confirmation for Exported Active Pharmaceutical Ingredients" (notified in documents G/TBT/N/UKR/216 and G/TBT/N/UKR/216/Add.1) shall be repealed. The draft Order also establishes that any procedure for quality certification of medicines for international trade and confirmation of active pharmaceutical ingredients intended for export, which has been initiated but not completed prior to the entry into force of this Order, shall be completed in accordance with the Procedure, approved by the Order of the Ministry of Health of 25 July 2022 No. 1310, which, for the purposes of completing such procedure, shall apply in the version effective as of the date of entry into force of this Order. Any decisions adopted following the completion of such procedure shall be issued in the forms approved by this Order.
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-IX "On Medicines" of 28 July 2022 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/216 G/TBT/N/UKR/216/Add.1 G/TBT/N/UKR/282 G/TBT/N/UKR/282/Add.1
9.	Proposed date of adoption: To be determined Proposed date of entry into force: 1 January 2027; This Order 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.
10.	Provision of comments Final date for comments: 23 July 2026 (45 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 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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