. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/150 
23 November 2005 
 (05-5546) 
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 government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
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:  info@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-prescription drugs 
and natural health products (ICS:  11.120) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to Certain Regulations Made under the Food and Drugs Act (Project No. 1474) 
(pages 3828-3836 in English and French) 
6. Description of content:   This regulatory amendment proposes to amend the  Food and Drug 
Regulations and the Natural Health Products Regulations to exempt drugs not listed on 
Schedule F to the  Food and Drug Regulations from the preventative and treatment 
prohibitions in subsections 3(1) and 3(2) of the Food and Drugs Act . Drugs not listed on 
Schedule F include non-prescription drugs under the Food and Drug Regulations and 
natural health products (NHPs) under the Natural Health Products Regulations .  
Prescription drugs, those with ingredients liste d on Schedule F, would still be required to 
comply with section C.01.044 of the Food and Drug Regulations  which restricts the 
advertising of prescription drugs, as well as  subsections 3(1) and 3(2) of the Food and 
Drugs Act .  
Non-prescription drugs and NHPs that have been  granted market authorization by Health 
Canada will be permitted to carry claims rega rding prevention and treatment for Schedule A G/TBT/N/CAN/150 
Page 2  
 
 diseases, disorders or abnormal physical states.  As is the case now, if any of the criteria 
used to place a drug on Schedule F is met duri ng the course of the review by Health Canada 
of any drug or NHP submission, then the submission would be reviewed as a potential Schedule F drug.  
The proposed regulatory amendment would a llow the Canadian public to be informed 
through advertising and labelling about benefits  associated with all self-care products that 
have been granted market authorization by Health Canada. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 19 November 2005 
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 6 to 8 months of publication 
in the Canada Gazette, Part I. 
On the date the measure is adopted 
10. Final date for comments:   2 February 2006 
11. Texts 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 regulatory text can be downloaded at:  
http://canadagazette.gc.ca/partI/2005/20051119/pdf/g1-13947.pdf