. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/160/Rev.1 
12 April 2011 
 (11-1828) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
NOTIFICATION 
 
Revision  
 
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, Ontario 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):  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. 1431 — Schedule F) 
(4 pages, available in English and French). 
6. Description of content:  The purpose of this Notice of Intent (NOI) is to provide an 
opportunity to comment on the revised proposal  to amend Part I of Schedule F to the Food 
and Drug Regulations  to add quinine, its salts and derivativ es except in oral dosage form that 
provides 50 mg or less of quinine base per dosage  unit or per daily dose.  This would result in 
affected products being regulated as  prescription drug products under the Food and Drug 
Regulations .  Since quinine meets the definition of a natural health product, products sold that 
contain an oral dosage form of 50 mg or less per unit dose or per daily dose would continue to 
be regulated under the Natural Health Products Regulations , and would not require a 
prescription.  
Sections C.01.041 to C.01.049 of the Food and Drug Regulations  control the sale of 
medicinal ingredients that are listed in Sche dule F. Part I of Sche dule F lists medicinal 
ingredients that require a prescription for huma n use and for veterinary use.  Part II of G/TBT/N/CAN/160/Rev.1 
Page 2  
 
  Schedule F lists medicinal ingred ients that require a prescripti on for human use, but do not  
require a prescription for veterinary use if so la belled or if in a form unsuitable for human use.  
Description of the medicinal ingredient:  Quinine is a medicinal ingredient that was origin ally made from the bark of several species of 
the cinchona tree and was used for centuries as the primary treatment for malaria.  The use of 
quinine as a malaria treatment declined over the years as new synthetic derivatives of the drug 
such as chloroquine and mefloquine were devel oped and used.  However, with increasingly 
drug-resistant strains of malaria appearing, there has been renewed interest in the use of quinine to treat malaria.  Quinine is now being used in combination with other drugs such as 
antibiotics to treat non-severe malaria infections caused by specific organisms that are 
resistant to other anti-malarial drugs. 
A review of the available scientific literature on quinine indicates that the use of quinine to 
treat malaria requires individualized instructions and/or direct practitione r supervision.  There 
is a narrow margin of safety between the therap eutic and toxic doses of quinine, especially in 
populations such as seniors, children, preg nant women or nursing mothers.  There are 
potential or known undesirable or severe side ef fects at normal therapeu tic dosage levels that 
would need to be managed by a practitioner.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette , Part I, 26 March 2011, Pages 1083-1086 
(available in English and French)   
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:  9 June 2011 
11. Text 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 regulator y text can be downloaded at:    
http://canadagazette.gc.ca/rp -pr/p1/2011/2011-03-26/pdf/g1-14513.pdf  (Canada Gazette) 
or  
http://canadagazette.gc.ca/rp-pr/p1/2011 /2011-03-26/html/notice-avis-eng.html#d110   
(English)  http://canadagazette.gc.ca/rp-pr/p1/2011/ 2011-03-26/html/notice- avis-fra.html#d110
  
(French)