| 1. | 通報(bào)成員：日本 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Ministry of Health, Labour and Welfare |
| 3. |
通報(bào)依據(jù)的條款：Technical Regulation (Article 2.9.2)
通報(bào)依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Pharmaceutical Products (HS:30)
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：
頁(yè)數(shù)：5 page(s) 使用語言：in English 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡(jiǎn)述： Under Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.
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| 7. | 目的和理由：To regulate the properties and quality of pharmaceuticals.; Protection of human health or safety; Quality requirements |
| 8. | 相關(guān)文件： The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. http://www.japaneselawtranslation.go.jp/law/detail/?ft=1&re=01&dn=1&co=01&ia=03&x=19&y=15&ky=the+law+on+securing+quality,+efficacy+and+safety+of+products+including+pharmaceuticals+medical+devices&page=1 This amendment will be published in "KAMPO" (Official? Gazette) when adopted. |
| 9. |
擬批準(zhǔn)日期：
The end of May 2019 (planned) 擬生效日期： The end of May 2019 (planned) |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)得到：
Japan Enquiry Point International Trade Division, Economic Affairs Bureau, Ministry of Foreign Affairs Fax: (+81 3) 5501 8343 E-mail: enquiry@mofa.go.jp
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Under Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.
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