. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/169 
8 August 2006 
 (06-3811) 
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. 1510 — Schedule F) (Available in English and French; 4 pages) 
6. Description of content:   Ranitidine is currently listed on Part I of Schedule F as 
“Ranitidine and its salts (except when sold in  a dosage form containing not more than the 
equivalent of 75 mg of ranitidine)”.  The wording of the current listing means that all 
strengths of ranitidine greater than 75 mg requi re a prescription in order to be sold for any 
condition of use in Canada. 
This Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to 
amend Part I of Schedule F to the Food and Drug Regulations to revise the listing for 
ranitidine and its salts to, “Ranitidine and its sa lts, except when sold in concentrations of 
150 mg or less per oral dosage unit and indicat ed for the treatment of heartburn”.  All 
strengths of ranitidine and its salts would have  prescription status when sold for conditions 
of use that require the intervention of a prac titioner, such as treatment of ulcers and gastro 
esophageal reflux disease. G/TBT/N/CAN/169 
Page 2  
 
  The non-prescription availability of a 150 mg strength of ranitidine provides a dose option 
to those heartburn sufferers who find that a 75 mg dose 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 prescription for human use, but 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 2247-2250 (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