. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/124 
20 May 2005 
 (05-2042) 
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. 1448 — Schedule F) (3 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 prop osed addition of Danofloxacin and its salts 
to Part I of Schedule F to the Food and Drug Regulations  to the Food and Drugs Act . 
Danofloxacin and its salts is a ‘third-g eneration’ fluoroquinolone antibiotic. 
Fluoroquinolones are a group of broad-spectrum an tibiotics that are used to treat bacterial 
infections by preventing bacterial growth.  Danof loxacin is used in veterinary medicine as 
the mesylate salt for the treatment of respir atory diseases in cattle, swine, and chickens. 
Danofloxacin is not intended for use in dair y cattle producing milk for human consumption 
and not in laying hens. 
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  G/TBT/N/CAN/124 
Page 2  
 
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 determined the necessity for prescription status for 
the medicinal ingredient in this proposed  amendment 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 applications. 
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/hpfb-dgpsa/t pd-dpt/index_regulations_e.html 
Project 1448, letter posted : 11 May 2005 
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:  25 July 2005 
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. 1448 can be downloaded at: http://www.hc-sc.gc.ca/hpfb-dgpsa/t pd-dpt/project_projet_1448_e.pdf