G/TBT/N/CAN/523/Add.1  
 
15 May 2018  
(18-2903) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English/French  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 15 May 2018, is being circulated at the request of the 
delegation of Canada .  
 
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Regulations Amending the Food and Drug Regulations (Vanessa’s Law)  
The proposed regulations notified in G/TBT/N/CAN/523 (dated 3 May 2017) were adopted and 
published on 2  May 2018 as the Regulations Amending the Food and Drug Regulations and the 
Regulations Amending the Food and Drug R egulations (DIN Requirements for Drugs Listed in 
Schedule C to the Food and Drugs Act that are in Dosage Form) . 
The regulations make a number of amendments to the Food and Drugs Regulations:  
1. Assessment and test and study orders made under Vanessa’s Law. In  order to support 
the coming into force of new powers under the Protecting Canadians from Unsafe Drugs 
Act (Vanessa’s Law) ,   new regulatory amendments   further define the scope of sections 
21.31 and 21.32 of Vanessa’s Law. These amendments will come into force when these 
new legislative powers come into force. Together, the new amendments and legislation 
will create and establish the scope of the Minister’s new authorities to order drug 
manufacturers to conduct assessments or to conduct additional tests an d studies. The 
amendments limit the scope of the new powers to drugs regulated under the Food and 
Drug Regulations . 
 
2. Notifying the Department of foreign actions regarding serious risk communications. 
Amendments will require the holder of an authorization ( made through the assignment 
of a Drug Identification Number or the issuance of a Notice of Compliance), for a 
prescription drug or a drug sold without a prescription that is to be administered only 
under the supervision of practitioners, to provide the Min ister of Health with information 
in respect of any serious injury to health the holder becomes aware of and that is 
relevant to the safety of the drug in Canada.  
 
3. Clinical case reports. The amendments repe al the requirement in 
paragraph  C.08.005.1(1)(a) to  provide clinical case reports when a new drug submission 
is filed with the Minister.  
These regulatory amendments were registered on 20 April 2018.  
The regulatory amendments in respect of the assessment and test and study order powers as well 
as the repeal of the requirement to provide clinical case reports came into force at the time these 
regulations were registered on 20 April 2018. The amendments respecting the notification of 
foreign action regarding serious risk come into force six mont hs follow ing registration on 
20 October  2018 to allow stakeholders time to effectively implement the new requirements.    
The full text of the adopted measure can be downloaded from the Internet addresses below:  
http://gazette.gc.ca/rp -pr/p2/2018/2018 -05-02/pdf/g2 -15209.pdf  
http://gazette.gc.ca/rp -pr/p2/2018/2018 -05-02/html/sor -dors84 -eng.html  
http://gazette.gc.ca/rp -pr/p2/2018/2018 -05-02/html/sor -dors84 -fra.html  G/TBT/N/CAN/523/Add.1  
 
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  or requested from:  
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  
 
 
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