| 通报号: G/TBT/N/CAN/468 |
ICS号: 11.120
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发布日期: 2015-10-08
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截至日期: 2015-10-08
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通报成员: 加拿大
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目标和理由: 保护人类安全和健康
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内容概述: 本评议通知的目的是提供机会，评议通过修订人用处方药清单（PDL）将埃索美拉唑的某些用途转变为人用非处方药的提案。
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正文:
| 世界贸易组织 |
G/TBT/N/CAN/468
2015-10-08
15-5234
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| 技术性贸易壁垒 |
原文：英语/法语
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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: 加拿大
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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负责机构:卫生部
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| 3. |
通报依据条款:
[ ] 2.9.2
[ ] 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： 人用处方药药物成分。其它。 ICS: 11.120 HS: 3004.90、300490
HS编码:300490 ICS编码:11.120
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| 5. |
通报标题： 评议通知－处方药清单（PDL）：埃索美拉唑
语言：英语和法语 页数：2 链接网址：
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| 6. |
内容简述： 本评议通知的目的是提供机会，评议通过修订人用处方药清单（PDL）将埃索美拉唑的某些用途转变为人用非处方药的提案。
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| 7. |
目标与理由:保护人类健康安全
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| 8. |
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| 9. |
拟批准日期:-
拟生效日期:-
[ ] 通报日后6个月，及/或(年月日)： 2015/12/16 [ ] 贸易促进措施
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| 10. |
意见反馈截止日期：
[ ] 通报发布日起60天，及/或(年/月/日):
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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: Canada
If applicable, name of local government involved (Article 3.2 and 7.2):
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2.
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Agency responsible: Department of Health
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:
Canada's Notification Authority and Enquiry Point
Foreign Affairs, Trade and Development Canada
Technical Barriers and Regulations Division (TIB)
111 Sussex Drive
Ottawa, ON K1A 0G2
Canada
Telephone: (343) 203-4273
Fax: (613) 943-0346
Email: enquirypoint@international.gc.ca
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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): Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90). – Other (HS: 300490)
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5.
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Title, number of pages and language(s) of the notified document: Notice of Consultation ? Prescription Drug List (PDL): Esomeprazole (2 pages, in English and French)
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6.
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Description of content: The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch certain uses of Esomeprazole to non?prescription status for human use by modifying the Human Prescription Drug List (PDL).
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7.
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Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety
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8.
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Relevant documents: Health Canada website: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/lead_pdl_ldo_consult_esomeprazole-eng.php, posted: 2 October 2015 (available in English and French)
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9.
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Proposed date of adoption: ?
Proposed date of entry into force: ?
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10.
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Final date for comments: 16 December 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:
The electronic version of the notice can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/lead_pdl_ldo_consult_esomeprazole-eng.php
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/lead_pdl_ldo_consult_esomeprazole-fra.php
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