G/TBT/N/CAN/491  
 
7 July 2016  
(16-3643)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: CANADA  
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Department of Health 
Name and address (including telephon e 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 : 
Canada's Notification Authority and Enquiry Point 
Global Affairs Canada 
Technical Barriers and Regulations Division (TIB) 111 Sussex Drive, Ottawa, ON K1A 0G2 Canada 
Telephone: (343)203-4273 
Fax: (613)943-0346 E-mail: enquirypoint@international.gc.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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable): Veterinary drugs 
(ICS: 11.220). Veterinary medicine 
5. Title, number of pages and language(s) of the notified document: 
 Regulations amending the Food and Drug Regulations (Veterinary Drugs – 
Antimicrobial Resistance) 
 Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) 
Regulations (51 pages, in English and French) 
6. Description of content: This regulatory proposal seeks to make amendments to the Food 
and Drug Regulations  to improve the regulatory oversight of antimicrobials for veterinary 
use. The proposed regulations would require veterinary active pharmaceutical ingredients 
imported or sold in Canada to be manufactured in accordance with good manufacturing 
practices, require persons that import, fabricate, package, label or test veterinary APIs to do so in accordance with an Establishment Licence, restrict the own use importation of 
unauthorized veterinary drugs, require manufacturers, importers and compounders of 
veterinary antimicrobials to provide sales volume information by species, and would introduce an alternative, less burdensome pathway for manufacturers to legally import and sell certain low risk veterinary drugs, known as veterinary health products, that could 
reduce the need for antimicrobials.  G/TBT/N/CAN/491 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: 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. Relevant documents:  
 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) 
9. Proposed date of adoption: Normally approximately 12 months following publication in 
the Canada Gazette, Part I 
Proposed date of entry into force: These Regulations would come into force six months 
after the day on which they are published in the Canada Gazette, Part II. In addition, a 
transitional provision would allow persons who fabricate, package/label, test and import veterinary active pharmaceutical ingredients would be permitted to continue conducting 
those activities without an establishment licence, provided that they have applied for one 
within six months after the coming into force of the regulations.   
10. Final date for comments: 15 September 2016  
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
The electronic version of the regulatory proposal can be found at: 
http://www.gazette.gc.c a/rp-pr/p1/2016/2016-07 -02/pdf/g1-15027.pdf  
http://www.gazette.gc.c a/rp-pr/p1/2016/2016-07 -02/html/reg2-eng.php   
http://www.gazette.gc.c a/rp-pr/p1/2016/2016-07 -02/html/reg3-eng.php   
http://www.gazette.gc.c a/rp-pr/p1/2016/2016-07 -02/html/reg2-fra.php   
http://www.gazette.gc.c a/rp-pr/p1/2016/2016-07 -02/html/reg3-fra.php