| 通报号: G/TBT/N/JPN/497 |
ICS号: 71.100.70,11.120,11.040
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发布日期: 2015-08-06
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截至日期: 2015-08-06
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通报成员: 日本
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目标和理由: 保护人类安全和健康
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内容概述: 药事法规定的指定物质（4种指定物质）及其“正确用途”提案
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正文:
| 世界贸易组织 |
G/TBT/N/JPN/497
2015-08-06
15-4058
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| 技术性贸易壁垒 |
原文：英语
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通 报
以下通报根据TBT协定第10.6条分发
| 1. |
通报成员: 日本
如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
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| 2. |
负责机构:厚生劳动省（MHLW）
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| 3. |
通报依据条款:2.10.1
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| 4. |
覆盖的产品： 可能影响中枢神经系统的物质
HS编码:30、90、9823、33 ICS编码:71.100.70,11.120,11.040
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| 5. |
通报标题： 指定物质，基于关于药品、医疗器械、再生细胞治疗产品、基因治疗产品和化妆品质量保证、功效和安全的法案规定（以下称为“法案”）（1960，法案No.145）。
语言：英语 页数：1 链接网址：
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| 6. |
内容简述： 药事法规定的指定物质（4种指定物质）及其“正确用途”提案
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| 7. |
目标与理由:为防止滥用可能影响中枢神经系统的物质，及依照药事法澄清法规，厚生劳动省（MHLW）指定此类物质为“指定物质”。禁止生产、进口、销售、拥有及使用“指定物质”，除依照药事法规定的“正确用途”以外。保护人类健康安全。
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| 8. |
相关文件: 批准时指定物质及其正确用途公布在官方公报上
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| 9. |
拟批准日期:2015/07/29
拟生效日期:2015/08/08
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| 10. |
意见反馈截止日期： 不适用
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| 11. |
文本可从以下机构得到:
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正文(英):
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
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1.
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Notifying Member: Japan
If applicable, name of local government involved (Article 3.2 and 7.2):
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2.
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Agency responsible: Ministry of Health, Labour and Welfare (MHLW)
Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:
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3.
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Notified under Article 2.9.2 [ ], 2.10.1 [X], 5.6.2 [ ], 5.7.1 [ ], other:
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4.
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Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Substances with probable effects on the central nervous system
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5.
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Title, number of pages and language(s) of the notified document: Designation of "Shitei Yakubutsu" (designated substances), based on the provision of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as the "Act") (1960, Law No.145) (1 page, in English)
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6.
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Description of content: Proposed "Shitei Yakubutsu" (designated 4 substances) and their "proper uses" designated under the Act.
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7.
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Objective and rationale, including the nature of urgent problems where applicable: In order to prevent the abuse of substances with probable effects on the central nervous system and to clarify the regulation under the Act, the MHLW designates such substances as "Shitei Yakubutsu".
Manufacture, import and sale, simple ownership and the use of "Shitei Yakubutsu" are banned except for the "proper uses" designated under the Act.
Protection of human health or safety
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8.
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Relevant documents: When adopted, "Shitei Yakubutsu" (designated substances) and their proper uses will be publicized in the Official Gazette, "KAMPO"
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9.
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Proposed date of adoption: 29 July 2015
Proposed date of entry into force: 8 August 2015
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10.
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Final date for comments: Not applicable
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11.
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Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:
Japan Enquiry Point
International Trade Division, Economic Affairs Bureau, Ministry of Foreign Affairs
Fax: (+81 3) 5501 8343
E-mail: enquiry@mofa.go.jp
https://members.wto.org/crnattachments/2015/TBT/JPN/15_3062_00_e.pdf
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