. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/275 
25 June 2009  
 (09-3114) 
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, Ontari o, 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):  Drugs for human use and 
veterinary drugs (ICS : 11.120, 11.220) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Adverse Drug Reaction Reporting)  (13 pages, available in 
English and French).  
6. Description of content:  The Adverse Drug Reaction (ADR) reporting section of the current 
Food and Drug Regulations requi res manufacturers to  analyze adverse drug reaction data for 
safety concerns and prepare an annual summary report. However, the Minister of Health (the 
Minister) has a limited ability to require the results of this report to be provided. This 
limitation does not support Health  Canada’s role in protecting and promoting the health and 
safety of all Canadians.  
The objective for government action is to strengt hen the current ADR reporting section of the 
Regulations in a way that benefits Canadian s while aligning it with other regulatory 
jurisdictions. The proposed amendment will requ ire manufacturers to notify the Minister 
when there has been a significant change in a drug’s risk-benefit profile. It will also permit the Minister to obtain the manufacturers’ analyses that led to these conclusions. This will permit 
the Minister to better moni tor the safety of the drug. 
These amendments pertain to drugs for human use, including biologics and pharmaceuticals, 
as well as veterinary drugs. They will require all drug manufacturers to notify the Minister if 
they conclude from their annual summary report that there has been a significant change in a drug’s risk-benefit profile. The amendments w ill also permit the Minister to direct 
manufacturers to provide summary reports or ca se reports whenever the Minister decides to 
examine the safety and effectiveness of a drug. The Minister will be able to impose a deadline G/TBT/N/CAN/275 
Page 2  
 
   of less than 30 days for submitting these reports  if a shorter deadline is necessary to respond 
to a serious and imminent risk to health. Manuf acturers will also be required to maintain 
individual ADR reports, case reports, annual summary re ports, and issue-related summary 
reports over a specified retention period, and to provide these record s to the Minister upon 
request.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and sa fety; protection of animal health  
8. Relevant documents:   Canada Gazette, Part I, 13 Ju ne 2009, Pages 1748-1760 (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:  12 August 2009 
11. Text available from: National enquiry po int [ X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
La version électronique du  texte réglementaire peut être téléchargée à :  
http://www.gazette.gc.ca/rp-p r/p1/2009/2009-06-13/pdf/g1-14324.pdf  (Gazette du Canada) 
ou http://www.gazette.gc.ca/rp-pr/p1/ 2009/2009-06-13/html/reg3-fra.html  
 (français) 
http://www.gazette.gc.ca/rp-pr/p1/ 2009/2009-06-13/html/reg3-eng.html  (anglais)