. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/122 
20 April 2005 
 (05-1618) 
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 and for veterinary use (ICS:  11.120, 11.220) 
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. 1385 — Schedule F) 
(pages 1086-1092; in English and French) 
6. Description of content:    
This Notice of Intent is to provide an opportunity to comment on the proposal to amend 
Part II of Schedule F to the Food and Drug Regulations  to the Food and Drugs Act  to 
provide exemptions to allow nonprescription status for   1. vitamin K
1 and K 2 in products intended for external use in humans; and  
 
2. vitamin K 1 and K 2 in oral dosage forms for u se in humans when the maximum 
 recommended daily dose is equal to or l ess than 120 micrograms (0.120 milligrams).  
 
In a coincident amendment, it is also proposed to add vitamin K 1 and K 2 to Item 3 of 
Schedule 1, Included Natural Health Product Substances, to the Natural Health Products G/TBT/N/CAN/122 
Page 2  
 
 Regulations .  However, the dosage forms and strengths of vitamin K remaining on 
Schedule F would not be considered to be natural health products in accordance with 
subsection 2(2) of the Natural Health Products Regulations .  (The Natural Health Products 
Regulations  were notified under G/TBT/N/CAN/25). 
 
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. 
Vitamin K is presently listed in Part II of  Schedule F without any qualifying phrases.  
 The Drug Schedule Status Committee determined that prescription status is no longer required for the strength and dosage forms in  the proposed amendments on the basis of 
established and publicly available criteria.  Th ese criteria include, but are not limited to, 
concerns related to toxicity, pharmacological  properties, and therapeutic applications. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human and animal health 
8. Relevant documents:   Canada Gazette, Part I, 9 April 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:  23 June 2005 
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/2005/20050409/pdf/g1-13915.pdf 
 
The electronic version of the Natural Health Products Regulations  (final rule to 
TBT/N/CAN/25; SOR/2003-196) can be downloaded at:  
http://canadagazette.gc.ca/partII/2003/20030618/pdf/g2-13713.pdf