. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/174 
30 August 2006 
 (06-4133) 
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. 1478 — Schedule F) (Available in English 
and French, 3 pages) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the proposed addition of resocortol and its 
derivatives to Part I of Schedule F to the Food and Drug Regulations . 
 Description of the medicinal ingredient: 
Resocortol and its derivatives  - is a corticosteroid that is used topically in veterinary 
medicine for the treatment of pyotraumatic dermatitis ("Hot Spots") in dogs. Resocortol 
butyrate should be used only under the supe rvision of a veterinarian since professional 
veterinary expertise is required to diagno se and treat pyotraumatic dermatitis. This 
medicinal ingredient also possesses the potentia l for undesirable side effects at normal 
therapeutic dosage levels, further reinforci ng the need for veterinary supervision. G/TBT/N/CAN/174 
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 adequate risk/benef it 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 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 Directorate (TPD) web site  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html 
Project No. 1478, letter posted: 18 August 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the letter 
on the TPD web site. 
Proposed date of entry into force:  On the date the measure is adopted.  
10. Final date for comments:   1 November 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. 1478 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1478_e.html