. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/299 
10 February 2010  
 (10-0758) 
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 governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Department of Health 
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 :  Canadian Enquiry 
Point, 200-270 Albert Street, Ottawa, Onta rio, Canada, K1P 6N7 Tel:  +1 613 238 3222, 
Fax:  +1 613 569 7808, E- mail:  enquirypoint@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 ve terinary 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. 1621 — Schedule F) (4 pages, available in 
English and French)  
6. Description of content:  This notification announces the availa bility of a letter that provides 
an opportunity to comment on the proposed addition of four medicinal ingredients to Part I of 
Schedule F to the Food and Drug Regulations.  
Description of the medicinal ingredients: 1.  Dirlotapide is a microsomal triglyceride tr ansfer protein inhibitor that is used to treat 
obesity in dogs.  Direct supervision by a pr actitioner and routine laboratory monitoring are 
required. Dirlotapide has the poten tial for undesirable side effect s at normal therapeutic doses. 
2.  Firocoxib is a COX-2 (cyclooxygenase) inhi bitor type of nonsteroidal anti-inflammatory 
drug (NSAID) that is used to control pain and inflammation associated w ith osteoarthritis in 
dogs. Firocoxib has the potential for undesirable side effects at normal therapeutic doses. 
There is a narrow margin of safety between the therapeutic and toxic dosages in younger and 
older dogs. 
3.  Ibafloxacin is a fluoroquinolone antibiotic that  is used to treat bact erial infections in dogs 
and cats.  Ibafloxacin has the potential for unde sirable side effects at  normal therapeutic 
doses.  A practitioner must provide individualize d instructions and supervision. Ibafloxacin 
may contribute to the development of resistant strains of micro-organisms. G/TBT/N/CAN/299 
Page 2  
 
  4.   Maripotant and its salts is a selective ne urokinin one (NK1) receptor antagonist that is 
used to treat and prevent acute vomiting in dogs.  Individualized instructions, direct 
practitioner supervision and routine laboratory monitoring are required.  Maripotant and its 
salts is used in serious disease states and its use may mask other ailments. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each medi cinal ingredient.  Oversight by a practitioner is 
necessary to ensure that appropriate risk/benef it information is considered before the drug 
containing the medicinal ingredient is administ ered and that the drug therapy is properly 
monitored. 
Schedule F is a list of medicinal ingredients, th e 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 huma n 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 Di rectorate (TPD) web site http://www.hc-
sc.gc.ca/dhp-mps/prodph arma/legislation/noti ce-avis/index-eng.php , Project No. 1621, letter 
posted:  1 February 2010   
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:  17 April 2010 
11. Text available from: National enquiry po int [ X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:   The electronic 
version of Project No. 1621 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1621-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1621-fra.php  
(French)