| 通報號: G/TBT/N/JPN/499 |
ICS號: 11
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發布日期: 2015-09-16
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截至日期: 2015-09-24
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通報成員: 日本
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目標和理由: 保護人類安全和健康
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內容概述: 部分修訂放射性藥品最低要求，增加了最近批準的放射性藥品標準。
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正文:
| 世界貿易組織 |
G/TBT/N/JPN/499
2015-09-16
15-4742
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| 技術性貿易壁壘 |
原文：英語
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通 報
以下通報根據TBT協定第10.6條分發
| 1. |
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. |
負責機構:厚生勞動省（MHLW）
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通報依據條款:2.9.2
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| 4. |
覆蓋的產品： 藥品。 HS: 30
HS編碼:30 ICS編碼:11
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| 5. |
通報標題： 部分修訂放射性藥品最低要求
語言：英語 頁數：1 鏈接網址：
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| 6. |
內容簡述：部分修訂放射性藥品最低要求，增加了最近批準的放射性藥品標準。
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| 7. |
目標與理由:為了公眾健康和衛生規定了藥品必須特別注意的生產加工、特性、質量、存儲標準及其它標準（放射性藥品）。
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| 8. |
相關文件: 關于藥品、醫療器械、再生細胞治療產品、基因治療產品和化妝品質量保證、功效和安全的法案。批準時本修訂公布在官方公報上。
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| 9. |
擬批準日期:放射性藥品批準之日
擬生效日期:放射性藥品批準之日
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| 10. |
意見反饋截止日期： 2015/09/24
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| 11. |
文本可從以下機構得到:
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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
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 [X], 2.10.1 [ ], 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): Pharmaceutical products (HS: 30)
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5.
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Title, number of pages and language(s) of the notified document: Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 pages, in English)
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6.
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Description of content: The minimum requirements for radiopharmaceuticals are to be partially amended to add the standards for a radiopharmaceutical to be newly approved.
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7.
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Objective and rationale, including the nature of urgent problems where applicable: To establish the standard for manufacturing process, properties, quality, storage and others of drugs to which special attention must be paid for the attainment of public health and sanitation (radiopharmaceuticals).
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8.
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Relevant documents: The act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics. This amendment will be published in "KAMPO" (Official Gazette) when adopted.
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9.
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Proposed date of adoption: The same day as the approval of the radiopharmaceutical
Proposed date of entry into force: The same day as the approval of the radiopharmaceutical
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10.
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Final date for comments: 24 September 2015
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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_3631_00_e.pdf
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