G/TBT/N/CAN/428
21 October 2014 
(14-6036)  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 telephon e 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 SPS & TBT 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 
E-mail: 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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Synthetic drug (ICS: 
11.120, 71.060) 
5. Title, number of pages and language(s) of the notified document: 
• Order Amending Schedule I to the Controlled Drugs and Substances Act 
(Tapentadol)  
• Regulations Amending the Narcotic Control Regulations (Tapentadol) (1 page, 
English and French) 
6. Description of content: The purpose of this initiative is to add the substance 
Tapentadolto Schedule I to the Controlled Drugs and Substances Act  (CDSA) and to the 
Schedule to the Narcotic Control Regulations  (NCR).  
Tapentadol is a synthetic opioid used for pain relief that has been marketed under the 
brand name NUCYNTA® since 2011 in immediate and controlled/extended-release (IR and 
CR/ER) formulations that, due to its opioid properties, may pose health and safety risks. 
While opioids like tapentadol are generally safe and effective, they can lead to physical and/or psychological dependence, abuse and/or addiction. 
Studies have shown that tapentadol has abuse liability potential comparable to 
hydromorphone, and is five times more potent for pain relief than intravenously-injected 
morphine.  Both hydromorphone and morphine  are already listed in Schedule I to the 
CDSA and the schedule to the NCR due to their diversion and abuse potential. 
In February 2011, a Notice to Interested Parties  proposed to add tapentadol, its salts and 
its related analogues under Schedule I of the CDSA and to the NCR. The proposed wording for the addition to the schedules has been modified since the NOI was published. As such, G/TBT/N/CAN/428 
 
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  the proposed amendment wouldadd tapentadol (3-[(1R, 2R)-3-(dimethylamino)-1-ethyl-2-
methylpropyl]-phenol), its salts, derivatives and isomers, and salts of derivatives and isomers to Schedule I to the CDSA  and the Schedule to the NCR. 
Scheduling tapentadol under the CDSA and the NC R will mitigate the risk of the potential 
diversion of tapentadol to an illicit market or use while allowing access for legitimate medical purposes. This proposed amendment is supported by the sole manufacturer and 
importer  of tapentadol in Canada and is consistent with the Government of Canada's 
continued commitment to address prescription drug abuse. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health 
8. Relevant documents:  Canada Gazette , Part I, 26 February 2011, Pages 656-657 
(available in English and French) 
9. Proposed date of adoption:   The date of adoption will be the date of entry into force 
Proposed date of entry into force:   Canada is proposing a delayed coming into force 
period of 90 days. This 90 day period will allow licensed dealers time to apply to add tapentadol to their licences and take the steps necessary to come into compliance by the 
coming into force date. Health Canada consulted with the association representing 
pharmaceutical manufacturers and distributors, as well as the market authorisation holder of tapentadol in Canada. These parties indicated they are supportive of this 90 day coming into 
force transition period. 
10. Final date for comments: 21 November 2014. A 30-day period is deemed to be sufficient 
given the following: Health Canada  published a Notice to Interested Parties in February 2011 
soliciting comments on the proposed amendment. Comments received indicated that 
stakeholders were fully supportive of this regulatory initiative, including the sole manufacturer of tapentadol for the Canadian market. No significant trade impacts are 
anticipated. The global developer/manufacture r has requested that tapentadol be placed 
under international control by having it scheduled under the UN Single Convention on Narcotic Drugs, 1961 as a precautionary measure.   
11. Texts available from: Nati onal enquiry point [X] 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://canadagazette.gc.ca/rp-pr/p 1/2011/2011-02-26/pdf/g1-14509.pdf  
http://canadagazette.gc.ca/rp-pr/p1/20 11/2011-02-26/h tml/notice-avis-eng.html   
http://canadagazette.gc.ca/rp-pr/p1/20 11/2011-02-26/h tml/notice-avis-fra.html