. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/309 
15 April 2010  
 (10-1931) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  CANADA   
If applicable, name of local governme nt 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 :   
Canadian Enquiry Point 
200-270 Albert Street Ottawa Ontario 
Canada, K1P 6N7  
Tel.:  +1 613 238 3222 Fax:  +1 613 569 7808 E-mail:  enquirypoint@scc.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):   
New Drugs for Extraordinary Use (ICS : 11.120) 
5. Title, number of pages and language(s) of the notified document:   
Proposed Amendment to the Food and Drug Regulations (1319 – New Drugs for 
Extraordinary Use) (23 pages, in English and French) 
Proposed Amendment to the Patented Medici nes (Notice of Compliance) Regulations 
(2 pages, in English and French) 
6. Description of content:   
The current regulations for the authorization for sale of a new drug in Canada include a 
requirement to provide substantial evidence demo nstrating the safety and efficacy of the drug 
for the purpose of and under the recommended conditions of use. While this standard is 
appropriate for most new drugs, there are ethi cal and/or logistical challenges in designing 
appropriate clinical trials for a small number  of emergency-use drugs, such as anthrax and 
pandemic influenza vaccines. These drugs are collectively referred to as Extraordinary Use 
New Drugs (EUNDs).   G/TBT/N/CAN/309 
Page 2  
 
  The current practice of using the Special Access Programme (SAP) to authorize the sale of 
EUNDs for broad distribution has already been determined to be  inappropriate by the Office 
of the Auditor General of Canada (OAG). The proposed regulatory amendment would create 
a new type of drug submission for an EUND within the Food and Drug Regulations (the Regulations). The inclusion criteria for EUNDs are provided, and the regulations also outline 
the requirements for EUND submissions, labelli ng, plans for post-market safety and efficacy 
studies and annual reporting. Exis ting regulations that apply to other drugs including, but not 
limited to, those regarding adverse drug re action reporting, establishment licensing, good 
manufacturing practices, and da ta and patent protection w ould also apply to EUNDs. 
7. Objective and rationale, including the nature of urgent problems where applicable:   
Protection of human health and safety  
8. Relevant documents:    
Canada Gazette, Part I, 3 April 2010, Page s 685-709 (available in English and French) 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 5 to 8 months of publication in 
the Canada Gazette, Part I 
On the date the measure is adopted 
10. Final date for comments:  17 June 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
The electronic version of the regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-p r/p1/2010/2010-04-03/pdf/g1-14414.pdf  (Canada Gazette) 
or  http://www.gazette.gc.ca/rp-pr/ p1/2010/2010-04-03/html/reg3-eng.html
 (Reg_English) 
http://www.gazette.gc.ca/rp-pr/ p1/2010/2010-04-03/html/reg3-fra.html  (Reg_French) 
http://www.gazette.gc.ca/rp-pr/ p1/2010/2010-04-03/html/reg4-eng.html  (Notice_English) 
http://www.gazette.gc.ca/rp-pr/ p1/2010/2010-04-03/html/reg4-fra.html  (Notice_French)