G/TBT/N/CAN/585  
 
24 April 2019  
(19-2767) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English/French  
 
  
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:  Health Canada  
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  
Global Affairs Canada  
Technical Barri ers and Regulations Division  
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):  The 
substance tramadol (ICS: 11.120)  
5. Title, number of pages a nd language(s) of the notified document:  Regulations 
Amending the Narcotic Control Regulations (Tramadol) (29 pages, available in English 
and French) Order Amending Schedule I to the Controlled Drugs and Substances Act 
(Tramadol) (2 pages, available in Eng lish and French)  
6. Description of content:  Tramadol is a synthetic opioid analgesic that has been marketed 
in Canada since 2005. It is regulated under the Food and Drugs Act, and is available by 
prescription only. Like other opioid analgesics, while tramadol can provide effective pain 
relief for some patients, it has potential for problematic use, and chronic use of tramadol 
can lead to tolerance and dependence.   Tramadol can also cause harmful adverse effects 
that pose risks to human health, which ca n be fatal in some cases.  
Unlike most opioid analgesics, tramadol is not scheduled under the Controlled Drugs and 
Substances Act or regulated under the Narcotic Control Regulations. Controlling tramadol 
would strengthen Health Canada’s oversight of legitim ate activities with tramadol, and 
facilitate detection and prevention of diversion. It would also enable Canadian law 
enforcement agencies to take enforcement action against a broader range of unauthorized 
activities with tramadol. This would help to mitig ate the risk of problematic tramadol use 
emerging as a significant threat to the health and safety of Canadians.  G/TBT/N/CAN/585  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  To prevent diversion of tramadol, and protect the health  and safety of 
Canadians  
8. Relevant documents:   
• Canada Gazette, Part I, 20 April 2019,  pages 1568 to 1598  (available in English 
and French)  
9. Proposed date of adoption:  Adoption is anticipated for Fall 2020.  
Proposed date of entry into force:  Entry into force is anticipated for Fall 2021.  
10. Final date for comments:  18 June 2019  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic version of the regulatory text can be downloaded at:  
 http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -04-20/html/reg2 -eng.html  
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -04-20/html/reg2 -fra.html  
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -04-20/html/reg3 -eng.html   
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -04-20/html/reg3 -fra.html