G/SPS/N/CAN/1040  
 
14 July 2016  
(16-3774)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English/French  
 
  NOTIFICATION 
1. Notifying Member: CANADA 
If applicable, name of local government involved:   
2. Agency responsible: Health Canada 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Veterinary health produc ts (ICS Code: 11.220) 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Proposed changes to Food and Drug Regulations  to 
address Antimicrobial Resistance (AMR) related to veterinary drugs  Language(s): 
English and French  Number of pages: 51 
6. Description of content: Health Canada is proposing changes to the Food and Drug 
Regulations  (FDR) to address the problem of antimicrobial resistance related to 
veterinary drugs. Currently the FDR do not pr ovide adequate controls to help mitigate 
the risks of AMR.  
Canada is seeking comments on proposed changes to:  
 restrict the importation of certain veterinary drugs; 
 require manufacturers and importers to follow stricter rules with regards to the 
quality of the active ingredients used in the fabrication of antimicrobials; 
 require manufacturers to provide sales information so that Health Canada can better 
monitor the use of antimicrobial drugs; and 
 introduce an easier way to access low-risk veterinary health products. 
Canada has also notified this measure to the TBT Committee (G/TBT/N/CAN/491). 
7. Objective and rationale: [ ] food safety, [ ] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pe st or disease, [ ] protect territory 
from other damage from pests. The overall objective of this proposal is to limit risks 
to human health by reducing the likelihood of resistance to antimicrobials in humans as 
a result of the use of antimicrobials for veterinary purposes. 
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None G/SPS/N/CAN/1040 
 
- 2 - 
 
  Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [X] No If no, describe, whenever possible, how and why it deviates from the 
international standard: There are no international standards; however the proposed 
regulations align with the International Conference on Harmonisation (ICH) Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 
(APIs). The Guideline, which has international adoption and acceptance, provides 
guidance regarding good manufacturing prac tice (GMP) for the manufacturing of APIs 
und e r an app rop riate  s yste m for manag ing  q uality . I t is  als o i nte nd ed  to he lp  e ns ure  
that APIs meet the requirements for qua lity and purity that they purport or are 
represented to possess. 
9. Other relevant documents and language (s) in which these are available:  
Food and Drug Regulations 
http://laws-lois.justice.gc.ca/eng/r egulations/c.r.c.,_c._870/index.html  (English) 
http://laws-lois.justice.gc.ca/fra/reg lements/C.R.C.%2C_ch._870/index.html  (French)  
Canada Gazette , Part I, 2 July 2016, Pages 2357-2407 (available in English and French)   
10. Proposed date of adoption (dd/mm/yy) : Normally approximately twelve months 
following publication in the Canada Gazette , Part I. 
Proposed date of publication (dd/mm/yy) :   
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : These Regulations would come into force six months after the 
day on which they are published in Canada Gazette  Part II. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 15 September 2016 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:   
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
The electronic version of the proposed policy document can be downloaded at:  
http://www.gazette.gc.ca/rp-pr/p1/ 2016/2016-07-02/pd f/g1-15027.pdf   
http://www.gazette.gc.ca/rp-pr/p1/ 2016/2016-07-02/html/reg2-eng.php  (English) 
http://www.gazette.gc.ca/rp-pr/p1/ 2016/2016-07-02/html/reg3-eng.php   
http://www.gazette.gc.ca/rp-pr/p1/ 2016/2016-07-02/html/reg2-fra.php  (French) 
http://www.gazette.gc.ca/rp-pr/p1/ 2016/2016-07-02/html/reg3-fra.php