G/TBT/N/CAN/587  
 
14 May 2019  
(19-3336) 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:  Health Canada  
Name and address (including telephone 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 Barri ers and Regulations Division  
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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drug 
products, biologics, and veterinary drugs (ICS:11.120)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug 
for Emergency Treatment) and Regulations Amending Certain Regulations Concerning the 
Sale of Drug s (Public or Canadian Armed Forces Health Emergencies) (43 pages, available 
in English and French)  
6. Description of content:  The Food and Drug Regulations (FDR) contains 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 administered through the Special Access Program (SAP), 
for human drugs and through the Emergency Drug Release Progra m (EDR) for veterinary 
drugs.  
There is a need for the FDR to clearly address the stockpiling of drugs by public health 
officials and requests for immediate use in a public or military health context. The 
proposed regulations would provide clarity on the ap plication requirements for public 
health officials, as well as reporting, record keeping and drug labelling requirements.    
Sale of a New Drug for Emergency Treatment  
This regulatory proposal seeks to make amendments to the "Sale of New Drug for 
Emergency Treatment " provisions in Division 8 of the FDR. The proposed amendments G/TBT/N/CAN/587  
 
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  would better reflect current operations and provide enhancements to the current 
processes administered by Health Canada 's SAP and EDR program.  
Public or Canadian Armed Forces Health E mergencies — Drugs for Immediate Use or 
Stockpiling  
A proposed new regulatory framework in Division 11 (Public or Canadian Armed Forces 
Health Emergencies — Drugs for Immediate Use or Stockpiling ) would allow public health 
officials at all levels of govern ment to request a specific quantity of an unauthorized drug 
in the following two scenarios:  
1. for immediate use in a military or public health emergency or event or incident;  
2. for the purposes of stockpiling in anticipation of a public or military health 
emergency or event or incident.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this proposal 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; and facilitating access to 
unauthorized drugs to address public or military health emergencies through an 
appropriate regulatory mechanism.  
8. Relevant documents:   
• Canada Gazette , Part I, 11 May 2019, pages 1806 -1849 (available in English and 
French)   
9. Proposed date of adoption:  It is anticipated that these regulations would be adopted 
12 months after publication in the Canada Gazette, Part I.  
Proposed date of entry into force:  The proposed regulatory amendments would come 
into force on the day on which the regulations are registered, which is anticipated to be 
12 months after Canada Gazette, Part I.  
10. Final date for comments:  19 July 2019  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic version of the regulatory text can be downloaded at:  
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -05-11/html/reg1 -eng.html   
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -05-11/html/reg 1-fra.html  
http://www.gazette.gc.ca/rp -pr/p1/2019/2019 -05-11/html/reg2 -eng.html  
http:/ /www.gazette.gc.ca/rp -pr/p1/2019/2019 -05-11/html/reg2 -fra.html