G/TBT/N/CAN/525  
 
8 May 2017  
(17-2471) 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 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 Barriers 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 [  ], 2.10.1 [ X], 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 
(ICS:  11.040, 11.1 20). Medical equipment (ICS 11.040), Pharmaceutics (ICS 11.120).  
5. Title, number of pages  and language(s)  of the notified document:  Regulations 
Amending the Food and Drug Regulations (Importation of Drugs fo r an Urgent Public 
Health Need)  (17 pages, in E nglish; 17 pages, in French)  
6. Description of content:  The Government of Canada is committed to making treatment 
options available to patients who require them in situations where this is an urgent public 
health need, including the current the opioid cri sis. The Government is taking action in a 
number of areas to address the impacts of problematic substance use, including supporting 
better treatment options for patients.  
To help respond to this need, Health Canada is proposing to allow the importation and  use 
of medications that have been authorized for sale in the United States, the European Union 
or Switzerland, but are not yet authorized in Canada.  
Once this process is implemented, the most immediate need is expected to be for drugs to 
treat opioid use disorder (addiction); however, drugs for other urgent public health needs 
(e.g., pandemics) could also be approved for importation through this new process.  
Health Canada will work with provincial, territorial and federal Chief Medical Officers of 
Health ( "public health officials") to explain the process for requesting access to a drug. To 
access a drug through this new process, public health officials would send a notification to 
Health Canada and provide key information on the drug, the urgent public heal th need, 
and how the drug is expected to help those in need in their jurisdiction. Once approved, 
the name and other details of the drug, such as the countries from which the drug could 
be imported, would be published on Health Canada's website.  G/TBT/N/CAN/525  
 
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  The drug w ould remain active on the list for one year, after which it would be removed 
unless Health Canada received a request for continued access. As with any drug sold in 
Canada, Health Canada would be able to issue a recall or take other necessary actions to 
protect the health and safety of Canadians should a safety concern arise.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
To address urgent public health needs, such as the growing opioid crisis, Health Canada is 
allowin g the importation of medications that have been authorized for sale in the United 
States, European Union or Switzerland, but that are not yet authorized in Canada.  
8. Relevant documents:  Canada Gazette,  Part I, 22 April 2017, pages 1732 -1748 (available 
in English and French)  
9. Proposed date of adoption: On the date the amendments are registered, Notification of 
registration will occur through publication in Canada Gazette, Part II, which is anticipated 
to be 28 June 2017 . 
Proposed date of entry into forc e: As this proposal would result in an enabling 
regulation meant to address a serious and ongoing public health crisis, it is proposed that 
the new regulations would be brought into force immediately upon registration by the Clerk 
of the Privy Council. At the same time, an Order in Council would bring into force the 
sections of Vanessa's Law necessary to implement requirements for serious adverse drug 
reaction reporting by health care institutions.  
10. Final date for comments:  7 May 2017  
11. Texts availab le from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
The electronic version of the regulato ry text can be downloaded at:  
http://www.gazette.gc.ca/rp -pr/p1/2017/2017 -04-22/html/reg3 -eng.php  (English)  
http://www.gazette.gc.ca/rp -pr/p1/2017 /2017 -04-22/html/reg3 -fra.php  (French)