G/TBT/N/CAN/405/Rev.1/Add.2  
 
13 April 2015  
(15-1967)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
  NOTIFICATION  
Addendum 
The following communication, dated 10 April 2015, is being circulated at the request of the 
delegation of Canada. 
 
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 Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to 
require & disclose information, power to order a label change and power to order a recall) 
This measure was previously notified under G/TBT/N/CAN/405/Rev.1 (dated 26 August 2014) and G/TBT/N/CAN/405/Rev.1/Add.1 (dated 18 November 2014). 
The Amendments to the Food and Drugs Act : Guide to New Authorities was developed to help 
Health Canada implement the new authorities that came into force upon royal assent of Bill C-17, 
the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) , on November 6, 2014, 
including: 
 The Minister's authority to require and disclose information, 
 The Minister's authority to order a label change/package modification, and 
 The Minister's authority to order a recall. 
The guide sets out principles, policy, and standa rds to follow when Health Canada identifies 
situations in which it may be appropriate for the Minister to exercise these new authorities. 
Specifically, the guide:  Sets out guiding principles that should govern all decisions made by Health Canada acting as 
a regulatory decision-maker, 
 Covers "when", "how", and "what" triggers the Minister's ability to make use of these 
authorities and explains to "whom" the authorities apply, 
 Increases the consistency and predictability for both health and industry as to how the 
authorities will be applied, resulting in improved quality of regulatory decision-making and improved compliance. 
The guide is also intended to support the develo pment of the operational tools (e.g., standard 
operations procedures (SOPs), guidance document s, process maps, templates) needed for those 
authorities which came into force immediately upon royal assent. It will also guide future regulatory and operational development for those authorities which require accompanying 
regulations. 
As a guidance document and administrative tool, the guide should be read in conjunction with the 
amended Food and Drugs Act  and the Food and Drug Regulations . 
The Guide to New Authorities is already in use by Health Canada but stakeholder comments on the 
clarity of the document will be consider ed before the document is finalized. 
This consultation is open for comment until 8 June 2015. The consultation document can be found at the Internet addresses below: G/TBT/N/CAN/405/Rev.1/Add.2 
 
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  http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/unsafedrugsact-guide-
lesdroguesdangereuses-eng.php  (English) 
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/unsafedrugsact-guide-
lesdroguesdangereuses-fra.php  (French) 
or requested from: 
Canada's Notification Authority and Enquiry Point 
Foreign Affairs, Trade and Development Canada 
Technical Barriers and Regulations Division 
111, promenade Sussex Drive Ottawa, ON K1A 0G2 Canada 
Tel/Tél: (343) 203-4273 
Fax/Téléc: 613-943-0346 E-mail/Courriel: enquirypoint@international.gc.ca  
 
 
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