| 通報(bào)號(hào): G/TBT/N/JPN/486 |
ICS號(hào): 11
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發(fā)布日期: 2015-05-11
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截至日期: 2015-05-11
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通報(bào)成員: 日本
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目標(biāo)和理由: 產(chǎn)品或技術(shù)安全要求
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內(nèi)容概述: 藥事法規(guī)定的指定物質(zhì)（827種指定物質(zhì)：這些物質(zhì)具有共同的化學(xué)結(jié)構(gòu)，1-苯基-1-丙酮為基本框架）及其“正確用途”提案。
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正文:
| 世界貿(mào)易組織 |
G/TBT/N/JPN/486
2015-05-11
15-2471
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| 技術(shù)性貿(mào)易壁壘 |
原文：英語(yǔ)
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通 報(bào)
以下通報(bào)根據(jù)TBT協(xié)定第10.6條分發(fā)
| 1. |
通報(bào)成員: 日本
如可能，列出涉及的地方政府名稱 ( 3.2條和7.2 條)：
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| 2. |
負(fù)責(zé)機(jī)構(gòu):厚生勞動(dòng)省（MHLW）
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通報(bào)依據(jù)條款:2.10.1
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| 4. |
覆蓋的產(chǎn)品： 可能影響中樞神經(jīng)系統(tǒng)的物質(zhì)
HS編碼:9802 ICS編碼:11
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| 5. |
通報(bào)標(biāo)題： 指定物質(zhì)，基于關(guān)于藥品、醫(yī)療器械、再生細(xì)胞治療產(chǎn)品、基因治療產(chǎn)品和化妝品質(zhì)量保證、功效和安全的法案規(guī)定（以下稱為“法案”）（1960，法案No.145）
語(yǔ)言：英語(yǔ) 頁(yè)數(shù)：1 鏈接網(wǎng)址：
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| 6. |
內(nèi)容簡(jiǎn)述： 藥事法規(guī)定的指定物質(zhì)（827種指定物質(zhì)：這些物質(zhì)具有共同的化學(xué)結(jié)構(gòu)，1-苯基-1-丙酮為基本框架）及其“正確用途”提案。
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| 7. |
目標(biāo)與理由:為防止濫用可能影響中樞神經(jīng)系統(tǒng)的物質(zhì)，及依照藥事法澄清法規(guī)，厚生勞動(dòng)省（MHLW）指定此類物質(zhì)為“指定物質(zhì)”。禁止生產(chǎn)、進(jìn)口、銷售、擁有及使用“指定物質(zhì)”，除依照藥事法規(guī)定的“正確用途”以外。保護(hù)人類健康。
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| 8. |
相關(guān)文件: 批準(zhǔn)時(shí)指定物質(zhì)及其正確用途公布在官方公報(bào)上
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| 9. |
擬批準(zhǔn)日期:2015/05/01
擬生效日期:2015/05/11
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| 10. |
意見反饋截止日期： 不適用
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| 11. |
文本可從以下機(jī)構(gòu)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 pages, in English).
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Description of content: Proposed "Shitei Yakubutsu" (designated 827 substances: All of these substances have a common chemical structure, 1-Phenyl-propan-1-one, as the basic frame.), 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.
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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: 1 May 2015
Proposed date of entry into force: 11 May 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_1918_00_e.pdf
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