. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/156 
21 March 2006 
 (06-1264) 
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):   Prescription status of 
medicinal ingredients for human use (ICS: 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Project No . 1490 — Schedule F) (5 pages in English and 
French) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the propo sed addition of a medicinal ingredient to 
Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredient: 
1. Tramadol and its salts  is a centrally acting synthetic opioid (narcotic) analgesic that is 
indicated for the short-term (five days or l ess) management of pain.  Although its mode 
of action is not completely understood at least two complementary mechanisms appear 
applicable: binding of parent and M1 me tabolite to µ-opioid receptors and weak 
inhibition of re-uptake of norepinephrine and serotonin.  It is not recommended for minor pain that may be treated adequately  through lesser means where benefit does not 
outweigh the possible opioid-related side effects.  Tramadol and its salts is 
contraindicated in any situation where opi oids are contraindicated, including acute 
intoxication with alcohol, hypnotics, narcoti cs, centrally acting analgesics, opioids or G/TBT/N/CAN/156 
Page 2  
 
  psychotropic drugs.  
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations .  Part I of Schedule F lists 
ingredients that require a prescription for human use and for veterinary use.  Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. 
The Drug Schedule Status Committee determines the necessity for prescription status for 
medicinal ingredients on the basis of established and publicly available criteria.  These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Therapeutic Products Directorate (TPD) web site  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html 
Project 1490 letter posted:  8  March 2006 
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:   22 May 2006 
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 Project No. 1490 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1490_e.html