   
  
IP/N/1/CAN/39  
IP/N/1/CAN/P/25  
 
7 March 2024  
(24-2091)  Page: 1/2 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English/French  
 
NOTIFICATION OF LAWS AND REGULATIONS  
UNDER ARTICLE 63.2 OF THE TRIPS AGREEMENT  
CANADA : PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS  
Notifying Member  CANADA  
 
Details of the notified legal text  
 
Title Patented Medicines (Notice of Compliance) Regulations  
Subject matter  Patents (including plant variety protection)  
Nature of 
notification  [X] Main dedicated intellectual property law or regulation  
[  ] Other law or regulation  
Link to legal text* https://ip -documents.info/2024/IP/CAN/24_01314_00_e.pdf   
https://ip -documents.info/2024/IP/CAN/24_01314_00_f.pdf  
Notification status  [  ] First notification  
[  ] Amendment or revision to notified legal text  
[X] Replacement or consolidation of notified legal text(s)  
Previous 
notification(s) 
referred to  IP/N/1/CAN/P/24  
Brief description of the notified legal text  
 
The 25 March 2011 amendments to the Patented Medicines (Notice of Compliance) (PM(NOC)) 
Regulations provide that the pathway by which Health Canada reviews and authorizes extraordinary 
use new drugs under the Food and Drug Regulations, such as military medical countermeasures and 
pandemic influenza vaccines, is reflected in the PM(NOC) Regulations.  
 
Language(s) of 
notified legal text English /French  
Entry into force  25 March 2011  
Other date    IP/N/1/CAN/39 • IP/N/1/CAN/P/25  
 
- 2 - 
 
   
Notification details  
 
Submission date 
of notification  5 February 2024  
Other information  PM(NOC) Regulations:  
https://laws -lois.justice.gc.ca/eng/regulations/sor -93-
133/20110325/P1TT3xt3.html   
 
Agency or 
authority 
responsible  Innovation, Science and Economic Development Canada  
Patent Policy Directorate  
235 Queen Street  
Ottawa  
Ontario K1A 0H5  
Canada  
 
 
 
* Links are provided to texts of laws and regulations notified under the TRIPS Agreement in the form 
supplied by the Member concerned; the WTO Secretariat does not endorse or revise their content.  