. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/207 
25 July 2007 
 (07-3185) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Canadian Enquiry Point  
200-270 Albert Street Ottawa, Ontario Canada, K1P 6N7  
Tel.:  +1 613 238 3222 
Fax.: +1 613 569 7808 E-mail: info@scc.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 and lang uage(s) of the notified document:    
Proposed Order Amending Schedule I to the Controlled Drugs and Substances Act.  
Proposed Amendment to the Narcotic Control Regulations. 
(8 pages, in English and French) 
6. Description of content:   The purpose of this initiative is to add the substance tramadol to 
Schedule I to the Controlled Drugs and Substances Act  (CDSA) and to the Schedule to the 
Narcotic Control Regulations  (NCR).  
 Manufacturers will also be required to change their product labels as all drugs regulated 
under the NCR must display an "N" on the outside  labels as dictated by section C.01.004 of 
the FDR.  The incremental costs associated with the change in regulatory status of tramadol 
is expected to be minimal for these manufacturers, and reasonable transition periods will be 
established to minimize the cost associ ated with these labelling changes.  
 G/TBT/N/CAN/207 
Page 2  
 
  Description of the substance 
Tramadol is a centrally acting synthetic anal gesic and an opioid agonist of the morphine 
type.  It is currently being sold in Canada in two formulations: as a low-dose combination 
product containing 37.5 mg of tramadol a nd 325 mg of acetaminophen, and as a single 
entity extended release formulation containi ng between 150 mg and 400 mg of tramadol.  
 
Scheduling 
The CDSA provides a legislative framework that prohibits and penalizes illicit activities 
with controlled substances unless otherwise aut horized by regulations for medical, industrial 
or scientific purposes. Substances regulated under the CDSA can alter mental processes and 
may produce harm to the health of an individua l or to society when diverted or misused. 
The substances controlled under the CDSA are grouped into six schedules, and each 
schedule is associated with sp ecific offences and punishments described in Part I of the Act. 
The NCR regulates the activities of producers, distributors, importers, exporters, health care 
professionals, and hospitals as they pertain to  narcotic drugs.  The NCR does not prevent 
practitioners from prescribing a substance when  it is required for the medical condition for 
which their patient is being treated.  Advertis ing to the general public is not possible under 
the NCR.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety 
8. Relevant documents:   Canada Gazette, Part I, 7 July  2007, Pages 2000-2007 (available in 
English and French). 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months from the 
posting of the letter on the TPD web site 
On the date the measure is adopted 
10. Final date for comments:   20 September 2007 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
The electronic version of the regulat ory text can be downloaded at: 
http://canadagazette.gc.ca/partI/2007/20070707/pdf/g1-14127.pdf