| 通报号: G/TBT/N/KOR/616 |
ICS号: 11.120.10
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发布日期: 2015-11-13
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截至日期: 2016-01-12
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通报成员: 韩国
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目标和理由: 产品或技术安全要求
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内容概述: 扩大包含存在安全和功效问题成分的指定产品：包含聚六亚甲基胍（PHMG）和寡(2-(2-乙氧基)乙氧基乙基氯化胍)（PGH）的吸入剂及其它类型产品，包含氯化十六烷吡啶（CPC）超过0.05%的产品，包含驱蝇定的产品。 通过仅允许在外用制剂中使用低于0.0015%的甲基氯异噻唑啉酮和甲基异噻唑啉酮调整准药品防腐剂使用范围。 对于与已经过再评估的准药品相同（成分、规格、剂型、类型、功效等）的产品，强制提交安全和功效数据（临床、毒性）。
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正文:
| 世界贸易组织 |
G/TBT/N/KOR/616
2015-11-13
15-6030
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| 技术性贸易壁垒 |
原文：英语
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通 报
以下通报根据TBT协定第10.6条分发
| 1. |
通报成员: 韩国
如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
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| 2. |
负责机构：韩国食品药品安全部（MFDS）
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| 3. |
通报依据条款：
[X] 2.9.2
[ ] 2.10.1
[X] 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： 准药品
HS编码：30 ICS编码：11.120.10
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| 5. |
通报标题： “准药品核准、通报和审议法规”修订提案
语言：韩国语 页数：36 链接网址：
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| 6. |
内容简述： 扩大包含存在安全和功效问题成分的指定产品：包含聚六亚甲基胍（PHMG）和寡(2-(2-乙氧基)乙氧基乙基氯化胍)（PGH）的吸入剂及其它类型产品，包含氯化十六烷吡啶（CPC）超过0.05%的产品，包含驱蝇定的产品。
通过仅允许在外用制剂中使用低于0.0015%的甲基氯异噻唑啉酮和甲基异噻唑啉酮调整准药品防腐剂使用范围。
对于与已经过再评估的准药品相同（成分、规格、剂型、类型、功效等）的产品，强制提交安全和功效数据（临床、毒性）。
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| 7. |
目标与理由：为了平衡准药品核准的审议、通报和检查及加强安全管理。
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| 8. |
相关文件： 韩国食品药品安全部（MFDS）公告No.2015-352(2015年11月9日)
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| 9. |
拟批准日期：待定
拟生效日期：待定
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| 10. |
意见反馈截止日期： 通报之后60天
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| 11. |
文本可从以下机构得到：
[ ] 国家通报机构
[ ] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
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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: Republic of Korea
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 Food and Drug Safety
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:
International Cooperation Office
Ministry of Food and Drug Safety
187 Osongsaengmyeong2-ro, Osong-eup
Heungdoek-gu Cheongju-si
Chungcheongbuk-do, 363-700
Republic of Korea
Tel: (+82) 43 719-1564
Fax: (+82) 43-719-1550
Email: wtokfda@korea.kr
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3.
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Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 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): Quasi-drugs
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5.
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Title, number of pages and language(s) of the notified document: Proposed amendments to the "Regulation on Quasi-Drug Approval, Notification and Review" (36 pages, in Korean)
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6.
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Description of content: Expand the designation of products containing problematic ingredients regarding safety and efficacy: inhalants and other types of products containing polyhexamethylene guanidine hydrochloride (PHMG), Oligo (2-(2-ethyoxy) ethoxyethylguanidium chloride (PGH), products containing more than 0.05% of Cetylpyridinium chloride (CPC), and products containing dipropylisocinchomeronate.
Adjust the allowed range of use for preservatives in quasi-drug by only allowing the use of methylchloro-isothiazolinone and methylisothia-zolinone for external preparations and under 0.0015%.
For products that are same (in ingredient, specification, dosage, type, efficacy, etc.) as a quasi-drug that has undergone re-evaluation, mandate the submission of safety and efficacy data (clinical, toxicity).
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7.
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Objective and rationale, including the nature of urgent problems where applicable: For balanced review of quasi-drug products' approval, notification and examination and strengthened safety management.
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8.
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Relevant documents: MFDS Notification No. 2015-352 (9 November 2015)
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9.
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Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined
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10.
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Final date for comments: 60 days from notification
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11.
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Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:
Technical Barriers to Trade(TBT) Division
Korean Agency for Technology and Standards (KATS)
93, Isu-ro, Maengdong-myeon
Eumseong-gun
Chungcheongbuk-do
Republic of Korea, 369-811
Tel.: (+82) 43 870 5525
Fax: (+82) 43 870 5682
E-mail: tbt@kats.go.kr
Website: http://www.knowtbt.kr
https://members.wto.org/crnattachments/2015/TBT/KOR/15_4566_00_x.pdf
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