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加拿大關(guān)于處方藥清單(PDL):埃索美拉唑的評議通知

嘉峪檢測網(wǎng)        2015-10-22 23:35

通報(bào)號: G/TBT/N/CAN/468
ICS號: 11.120
發(fā)布日期: 2015-10-08
截至日期: 2015-10-08
通報(bào)成員: 加拿大
目標(biāo)和理由: 保護(hù)人類安全和健康
內(nèi)容概述: 本評議通知的目的是提供機(jī)會(huì),評議通過修訂人用處方藥清單(PDL)將埃索美拉唑的某些用途轉(zhuǎn)變?yōu)槿擞梅翘幏剿幍奶岚浮?br />
正文: 
世界貿(mào)易組織
G/TBT/N/CAN/468
2015-10-08
15-5234
 
技術(shù)性貿(mào)易壁壘
原文:英語/法語
 
通 報(bào)


                   以下通報(bào)根據(jù)TBT協(xié)定第10.6條分發(fā)

1.
通報(bào)成員: 加拿大
如可能,列出涉及的地方政府名稱 ( 3.2條和7.2 條):
2.
負(fù)責(zé)機(jī)構(gòu):衛(wèi)生部
3.
通報(bào)依據(jù)條款:
[ ] 2.9.2
[ ] 2.10.1
[ ] 5.6.2
[ ] 5.7.1
通報(bào)依據(jù)的條款其他:
4.
覆蓋的產(chǎn)品: 人用處方藥藥物成分。其它。 ICS: 11.120 HS: 3004.90、300490
HS編碼:300490   ICS編碼:11.120
5.
通報(bào)標(biāo)題: 評議通知-處方藥清單(PDL):埃索美拉唑

語言:英語和法語 頁數(shù):2 鏈接網(wǎng)址:
 
6.
內(nèi)容簡述: 本評議通知的目的是提供機(jī)會(huì),評議通過修訂人用處方藥清單(PDL)將埃索美拉唑的某些用途轉(zhuǎn)變?yōu)槿擞梅翘幏剿幍奶岚浮?/div>
7.
目標(biāo)與理由:保護(hù)人類健康安全
8.
相關(guān)文件: 加拿大衛(wèi)生部網(wǎng)站: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/lead_pdl_ldo_consult_esomeprazole-eng.php ,2015年10月2日(英語和法語)
9.
擬批準(zhǔn)日期:-
擬生效日期:-
[ ] 通報(bào)日后6個(gè)月,及/或(年月日): 2015/12/16 [ ] 貿(mào)易促進(jìn)措施
10.
意見反饋截止日期:
[ ] 通報(bào)發(fā)布日起60天,及/或(年/月/日):
11.
文本可從以下機(jī)構(gòu)得到:
[ ] 國家通報(bào)機(jī)構(gòu)
[ ] 國家咨詢點(diǎn),或其他機(jī)構(gòu)的聯(lián)系地址、傳真及電子郵件地址(如能提供):

正文(英): 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: Canada

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

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

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

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)

5.

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)

6.

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).

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

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)

9.

Proposed date of adoption: ?

Proposed date of entry into force: ?

10.

Final date for comments: 16 December 2015

11.

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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