. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/348 
19 October 2011  
 (11-5199) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  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):  Non-Medicinal 
Ingredients (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 (1470 - Non-Medi cinal Ingredients) (13 pages, available in 
English and French)  
6. Description of content:  Applications for drugs regulated sole ly under Part C, Division 1, of 
the Food and Drug Regulations  (those drugs that have been sold in Canada for a sufficient 
time and in sufficient quantity to establish safety  and effectiveness, i.e. the majority of non-
prescription drugs) are not  required to include information on the non-medicinal ingredients 
(NMIs) present in the formulation of the drug. As a result, Health Canada generally does not 
receive a complete quantitative list of NMIs for Division 1 drugs, unless voluntarily provided 
by the manufacturer of the drug. Therefore, if a health risk to Canadians is posed by a specific 
NMI, Health Canada is limited in its capacity to develop risk management strategies since it 
would be challenging to identify the Divisi on 1 drugs on the market which contain the 
ingredient in question.  
The proposed regulatory amendment would appl y to prescription and non-prescription drugs 
intended for human and animal use that are sole ly regulated under Part C, Division 1, of the 
Food and Drug Regulations . The amendment would not affect drugs that are regulated under 
Division 8 of the Food and Drug Regulations  (i.e. new drugs) as they are already subject to 
similar requirements. 
The proposed changes to the Food and Drug Regulations  would introduce the following 
requirements:  G/TBT/N/CAN/348 
Page 2  
 
  (1) The submission of a full quantitative list of all the NMIs present in a drug as part of a 
 Drug Identification Number  (DIN) application.  
(2) That sponsors of currently marketed Division 1 drugs submit their full product 
 formulations to Health Canada. 
(3) That subsequent changes to the formul ation of a drug holding a DIN and present on 
 the market, be submitted to Health Ca nada within 30 days of the change.  
The proposed regulatory amendment would be complementary to Proj ect 743 addressing 
NMI labelling recently published in the Canada Gazette , Part II (G/TBT/N/CAN/271/Add.1), 
which requires sponsors to list the NMIs on the out er labels of drugs, with some exceptions. 
Those Regulations, which will come into fo rce on May 13, 2012, will provide consumers 
with label information about NMIs which will assist them in avoiding allergens and agents for which they have a history of adverse reactio ns. The current proposal would provide Health 
Canada with NMI information that may enhanc e risk management ac tivities should issues 
arise post-market. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety  
8. Relevant documents:   Canada Gazette , Part I, 8 October  2011,  Pages 3212-3224 (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. 
One year after the date the measure is adopted. 
10. Final date for comments:  22 December 2011 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of the regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-pr/ p1/2011/2011-10-08/pdf/g1-14541.pdf#page= 92 (Canada 
Gazette) 
or  http://www.gazette.gc.ca/rp-pr/ p1/2011/2011-10-08/html/reg4-eng.html  (English) 
http://www.gazette.gc.ca/rp-pr/ p1/2011/2011-10-08/html/reg4-fra.html  (French)