. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/166 
26 July 2006 
 (06-3590) 
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 veterinary use (ICS:  11.220). 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Project No . 1491 — Schedule F) (3 pages; English and 
French). 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the proposed addition of deracoxib to Part I of 
Schedule F to the Food and Drug Regulations . 
Description of the medicinal ingredient: 
 
Deracoxib  is a cox-2 inhibitor belonging to the NSAID (non-steroidal anti-
inflammatory) class of drugs.  Deracoxib is indicated for the relief of pain and 
inflammation associated with orthopedic  surgery and osteoarthritis in dogs. 
Deracoxib is the first coxib class NSAID for use in animals.  The human NSAID drugs are not very useful for dogs as metabo lism of the drugs is not predictable in 
individual dogs.  Deracoxib has a predic table duration of action and dose response 
in dogs.  G/TBT/N/CAN/166 
Page 2  
 
   
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with this medi cinal ingredient.  Oversight by a veterinarian 
is necessary to ensure that appropriate risk/ben efit information is considered before the drug 
containing the medicinal ingredient is administered and that the drug therapy is properly 
monitored. 
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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of animal 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 No. 1491, letter posted: 14 July 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:   27 September 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. 1491 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1491_e.html