| 1. | 通报成员:中国 |
| 2. | 负责机构:National Medical Products Administration |
| 3. |
通报依据的条款:Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ]
通报依据的条款其他:
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| 4. | 覆盖的产品:Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products (HS 3002); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Medicaments (ICS 11.120.10)
ICS:[] HS:[] |
| 5. |
通报标题:Administrative Measures for Lot Release of Biological Products (Revised Draft for Comments)页数:22 使用语言:英语 链接网址: |
| 6. |
内容简述: In order to strengthen the management of lot release of biological products, and ensure the quality and safety of biological products. |
| 7. | 目的和理由:Protection of human health or safety; Quality requirements |
| 8. | 相关文件: |
| 9. |
拟批准日期:
To be determined 拟生效日期: To be determined |
| 10. | 意见反馈截至日期:60 days from notification |
| 11. |
文本可从以下机构得到:
WTO/TBT National Notification and Enquiry Center of the People's Republic of China https://members.wto.org/crnattachments/2020/TBT/CHN/20_0025_00_x.pdf |
In order to strengthen the management of lot release of biological products, and ensure the quality and safety of biological products.