G/TBT/N/CAN/523  
 
3 May 2017  
(17-2401) 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 [  ], 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):  Prescription and Ethical 
Drug Pr oducts (ICS: 11.040, 11.120)  
5. Title, number of pages  and language(s)  of the notified document:  Regulations 
Amending the Food and Drug Regulations (Vanessa's  Law) (29 pages, in English; 
29 pages, in French)  
6. Description of content:  On 6 November 2014,  the Protecting Canadians from Unsafe 
Drugs Act (Vanessa's Law) received royal assent and amended the Food and Drugs Act to 
enable Health Canada to effectively and efficiently regulate the approval and safety of 
drugs for Canadians based on a lifecycle app roach.  
This proposal would amend the Food and Drug Regulations by introducing regulations that 
govern the issuance of Ministerial orders to reassess the benefits and harms of a drug, or 
conduct additional tests and studies. The amendment would also requir e therapeutic 
product authorization holders to provide the Department with the foreign risk 
communication(s) undertaken within the jurisdictions of specified foreign authorities. It 
would also repeal the requirement, under Division 8 of the Food and Drug R egulations, to 
provide clinical case reports.  
These regulations would support the coming into force of the new assessment and test and 
studies powers included in Vanessa's Law by establishing the rules needed to structure the 
exercise of those powers. They  would further support post -market drug safety by creating 
new foreign incident reporting rules. Finally, the regulations would reduce unnecessary 
requirements by removing a NDS reporting obligation.  G/TBT/N/CAN/523  
 
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  7. Objective and rationale , including the nature of urg ent problems where applicable: 
Protection of human health or safety  
8. Relevant documents:  Canada Gazette, Part I, 22 April 2017, pages 1749 -1777 (available 
in English and French)  
9. Proposed date of adoption: On the date the amendments are registered. N otification of 
registration will occur through publication in Canada Gazette, Part II, which is anticipated 
to be 12 months following publication in Canada Gazette, Part I.   
Proposed date of entry into force: The proposed ame ndments would come into force 
6 months after the day on which they are published in Canada Gazette, Part II.  
10. Final date for comments:  6 July 2017  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if availabl e, of other body:   
The electronic version of the regulatory text can be downloaded at:   
http://www.gazette.gc.ca/rp -pr/p1/2017/2017 -04-22/html/reg4 -eng.php  (anglais) 
http://www.gazette.gc.ca/rp -pr/p1/2017/2017 -04-22/html/reg4 -fra.php  (français)