. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/168 
8 August 2006 
 (06-3813) 
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):   Prescription status of 
medicinal ingredients for human use (ICS : 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Notice of Intent — Project No. 1496 — Schedule F) (Available in English and French, 3 pages) 
6. Description of content:   Famotidine is currently listed on Part I of Schedule F as 
"Famotidine and its salts (except in preparati ons for oral use containing 10 mg or less of 
famotidine per dosage unit)".  The wording of th e current listing means that all strengths of 
famotidine greater than 10 mg require a prescripti on in order to be sold for any condition of 
use in Canada.  
This Notice of Intent (NOI) is to provide an opportunity to comment on the proposal to 
amend Part I of Schedule F to the Food and Drug Regulations  to revise the listing for 
famotidine and its salts to "Famotidine and its salts, except when sold in preparations for 
oral use containing 20 mg or less of famotidine per dosage unit and indicated for the 
treatment of heartburn".  All strengths of famotidine and its salts would have prescription 
status when sold for conditions of use that re quire the intervention of a practitioner, such as 
treatment of ulcers and gastro esophageal reflux disease. G/TBT/N/CAN/168 
Page 2  
 
 The availability of a nonprescription 20 mg strength of famotidine will provide an option to 
those heartburn sufferers who find that a 10 mg dose of famotidine is not sufficiently effective. 
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations . Part I of Schedule F lists 
ingredients that require a prescription for human use and for veterinary use.  Part II of 
Schedule F lists ingredients that require a prescr iption for human use but that do not require 
a prescription for veterinary use if so labelled or if in a form unsuitable for human use.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:   Canada Gazette, Part I, 29 July  2006, Pages 2245-2247 (available in 
English and French) 
Proposed date of adoption:   
 Normally within 6 to 8 months of publication 
in the Canada Gazette, Part I. 9. 
Proposed date of entry into force:    
On the date the measure is adopted. 
10. Final date for comments:   12 October 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 Notice of Intent can be downloaded at:  
http://canadagazette.gc.ca/partI/2006/20060729/pdf/g1-14030.pdf