. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/257/Rev.1 
24 April 2009  
 (09-1956) 
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, 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):  Prescription status of 
medicinal ingredients fo r 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. 1594 — Schedule F)  
(4 pages, in English and French). 
6. Description of content:  This revised Notice of Intent (NO I) is to provide an opportunity for 
comment on the proposal to amend Part I of Sc hedule F to the Food and Drug Regulations to 
revise the listing for fluconazo le to allow nonprescription stat us for fluconazole 150 mg for 
oral use for the treatmen t of vaginal candidiasis.  
An initial NOI was published in the Canada  Gazette, Part I, on 10 January 2009 
(G/TBT/N/CAN/257), that requires modification.  The 10 January 2009, NOI stated that the 
amendment would come into force on the date  of registration. As there are multiple 
manufacturers of products containing flucon azole 150 mg for the treatment of vaginal 
candidiasis, a coming into force at a date later than the date of publication of the amendment 
in the Canada Gazette, Part II, is needed to allow these manufacturers the opportunity to have 
nonprescription labelling approved for their pro ducts. This revised NOI reflects these 
considerations. 
Fluconazole is currently listed in Part I of Schedule F without any qualifying phrases or 
exceptions. This means that al l strengths of fluconazole curr ently require a prescription in 
order to be sold in Canada. G/TBT/N/CAN/257/Rev.1 
Page 2  
 
  Schedule F is a list of medicinal ingredients, th e sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulatio ns. Part I of Schedule F lists ingredients 
that require a prescription for human use and fo r veterinary use. Part II of Schedule F lists 
ingredients that require a prescription for hu man use, but do not require a prescription for 
veterinary use if so labelled or if  in a form unsuitable for human use. 
Fluconazole is a triazole antifungal agent i ndicated for the treatm ent of vaginal yeast 
infections due to Candida. Vagi nal candidiasis is a common vagi nal yeast infection affecting 
many women. The proposed nonprescription fl uconazole 150 mg would have exactly the 
same indications for use as the currently available prescription fluconazole 150 mg. Single-dose orally administered flucona zole 150 mg has been available in Canada as a prescription 
drug for treatment of vaginal candidiasis since 1994. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette, Part I, 11 Ap ril 2009, Pages 940-943 (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. 90 days after the date of publication of the NOI in the Canada Gazette, Part II. 
10. Final date for comments:  25 June 2009 
11. Text available from: National enquiry po int [ 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 Notice of Intent can be downloaded at:  
http://www.gazette.gc.ca/rp-p r/p1/2009/2009-04-11/pdf/g1-14315.pdf  (Canada Gazette) 
or  
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-04-11/html/notice-avis-eng.html#d110  
(English) http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-04-11/html/notice- avis-fra.html#d110
 (French)