G/TBT/N/CAN/528  
 
20 June 2017  
(17-3282) 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 [ X], 2.10.1 [   ], 5.6.2 [ X], 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 - 
Opioids (ICS: 1 1.040, 11.120)  
5. Title, number of pages  and language(s)  of the notified document:  Regulations 
Amending the Food and Drug Regulations (Opioids) (34 pages, available in English and 
French)  
6. Description of content:  The potential for harm associated with opioid drugs and the 
growing related public health crisis is the subject of increasing concern for Canadians and 
other levels of government in Canada. Health Canada has identified the need for 
strengthened post -market oversight of opioids to help monitor a nd mitigate their risks, and 
the need for patients to receive additional, clear information about the safe use of opioids 
and the ri sks associated with their use.  
The proposed amendments to the Food and Drugs Regulations  would expressly permit the 
Minister  of Health to add or amend terms and conditions to an authorization for the sale of 
an opioid. This authority could then be used by the Minister to compel an opioid 
authorization holder to develop and implement a risk management plan to appropriately 
monit or, quantify, characterize and mitigate the risks associated with post -market use of 
these products. The proposed amendments would also require that a patient information 
handout and warning sticker accompany prescription opioids at the time of sale.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
The proposed amendments are necessary to protect Canadians from the serious and 
growing public health threat presented by the opioid crisis. Providing the Minister with an 
ability to impose enforceable terms and conditions for opioids will significantly improve G/TBT/N/CAN/528  
 
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  Health Canada' s post -market oversight of these drugs so that their risks can be better 
identified and mitigated. Requiring a warning sticker and patient information han dout for 
prescription opioids at time of sale will provide key information to patients about the safe 
use of opioids and their associated risks of dependency, addiction and potentially fatal 
overdose.  
8. Relevant documents:  Canada Gazette , Part I, 17 June  2017, pages 2655 -2688 (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 12 months followin g publication in Canada Gazette, Part I.  
Proposed date of entry into force: The proposed regulatory amendments in respect of 
terms and conditions to increase post -market oversight of opioids would come into force on 
the day on which the regulations are reg istered to address an urgent public health crisis.  
The proposed regulatory amendments in respect of the patient information handout and 
warning sticker would come into force six months after the day on which the regulations are 
registered to allow stakehol ders time to effectively implement the new requirements.  
10. Final date for comments:  31 August 2017  
11. Texts available 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 regulatory text can be downloaded at:  
http://www.gazette.gc.ca/rp -pr/p1/2017/2017 -06-17/html/reg8 -eng.php  
http://www.gazette.gc.ca/rp -pr/p1/2017/2017 -06-17/html/reg8 -fra.php