. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/289 
18 December 2009  
 (09-6624) 
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, Ontari o, 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. 1596 — Schedule F) (4 pages,  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 additi on of three medicinal ingredients to Part I 
of Schedule F to the Food and Drug Regulations. 
Description of the medicinal ingredients: 
1.  Imidapril and its salts and derivatives is an angiotensin converting enzyme (ACE) inhibitor 
that is used to treat high blood pressure in dogs. Practitioner expertise is required to diagnose 
the specific condition causing high blood pres sure. The condition may require additional 
treatment with other prescription drugs and ro utine laboratory monitoring. Imidapril and its 
salts and derivatives possesses the potential for undesirable side effects at normal therapeutic 
doses. 
2. Tepoxalin and its derivatives is a nonsteroida l anti-inflammatory drug (NSAID) that is used 
to control pain and inflammation associated  with musculoskeletal disorders in dogs. 
Tepoxalin and its derivatives has the potenti al for undesirable side effects at normal 
therapeutic doses. There is a narrow margin of safety between the therapeutic and toxic 
dosages in older dogs. G/TBT/N/CAN/289 
Page 2  
 
   3.  Tulathromycin is a macrolide antibiotic th at is used to treat lung infections such as 
pneumonia in cattle and pigs. Di rect practitioner supervision and monitoring are required for 
diagnosis and for the safe use of this pr oduct. Tulathromycin may contribute to the 
development of resistant st rains of micro-organisms. 
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 Regulatio ns. Part I of Schedule F lists ingredients 
that require a prescription for human use and fo r veterinary use. Part II of Schedule F lists 
ingredients that require a prescription for hu man 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) we b site http://www.hc-
sc.gc.ca/dhp-mps/prodphar ma/legislation/notice-avis/index-e ng.php, Project No. 1596, letter 
posted: 7 December 2009   
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 February 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. 1596 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1596-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1596-fra.php  
(French)