| 通報號: G/TBT/N/JPN/497 |
ICS號: 71.100.70,11.120,11.040
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發(fā)布日期: 2015-08-06
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截至日期: 2015-08-06
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通報成員: 日本
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目標(biāo)和理由: 保護(hù)人類安全和健康
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內(nèi)容概述: 藥事法規(guī)定的指定物質(zhì)（4種指定物質(zhì)）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/497
2015-08-06
15-4058
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| 技術(shù)性貿(mào)易壁壘 |
原文：英語
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通 報
以下通報根據(jù)TBT協(xié)定第10.6條分發(fā)
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通報成員: 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)機構(gòu):厚生勞動?。∕HLW）
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| 3. |
通報依據(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:30、90、9823、33 ICS編碼:71.100.70,11.120,11.040
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| 5. |
通報標(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）。
語言：英語 頁數(shù)：1 鏈接網(wǎng)址：
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| 6. |
內(nèi)容簡述： 藥事法規(guī)定的指定物質(zhì)（4種指定物質(zhì)）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?。∕HLW）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)人類健康安全。
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| 8. |
相關(guān)文件: 批準(zhǔn)時指定物質(zhì)及其正確用途公布在官方公報上
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| 9. |
擬批準(zhǔn)日期:2015/07/29
擬生效日期:2015/08/08
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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 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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