   
  
G/TBT/N/CAN/587/Add.1  
 
23 October 2020  
(20-7356) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English, French  
 
NOTIFICATION  
Addendum  
The following communication , dated  23 October 2020 , is being circulated at the request of the 
delegation of Canada . 
 
_______________  
 
 
Title: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New 
Drug for Emergency Treatment)  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[X] Notified measure adopted - date: 14 October 2020  
[X] Notified measure published - date: 14 October 2020  
[X] Notified measure enters into force - date: 28 September 2020  
[X] Text of final measure available from1:  
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -10-14/html/sor -dors212 -eng.html   
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -10-14/html/sor -dors212 -fra.html  
http://www.gazette.gc.ca/rp -pr/p2/2020/2020 -10-14/pdf/g2 -15421.pdf#page=111  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  The proposed regulations notified in G/TBT/N/CAN/587 (dated 14 May 2019) were 
adopted and published on 14 October 2020 as the Regulations Amending Certain Regulations Made 
Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment).  
The Food  and Drug Regulations  (FDR) contain emergency provisions, which can be used in certain 
circumstances to provide Canadians with access to human and veterinary drugs in medical 
emergencies when the drug is not authorized in Canada.   These provisions are admi nistered through 
the Special Access Program (SAP) for human drugs and through the Emergency Drug Release 
Program (EDR) for veterinary drugs.  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  G/TBT/N/CAN/587/Add.1  
 
- 2 - 
 
  The objective of this regulatory change is to facilitate access to drugs for Canadians by modernizing 
the emergency provisions in the FDR to arrive at less burdensome processes for drugs accessed 
through the SAP or EDR program.  
Sale of a New Drug for Emergency Treatment  
The amendments will revise the current emergency provisions of the Food and Drug Regulation s to:  
1. Provide a less burdensome process for a practitioner requesting a drug previously 
authorized through the SAP or the EDR program for use in the emergency treatment of a 
human or animal patient;  
2. Establish a regulatory mechanism for situations when ma nufacturers wish to import drugs 
into Canada in anticipation of a request from a practitioner ("pre -position"); and  
3. Provide required additional amendments.  
__________  
 
 