. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/138 
2 September 2005 
 (05-3829) 
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 (Project No. 1370 — Schedule F) (4 pages, in English and French) 
6. Description of content:   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 the Food and Drugs Act  to remove nicotine from Schedule F, when administered by an 
oral lozenge containing 4 mg or less of nico tine per lozenge.  The lozenge containing 4 mg 
or less of nicotine is an alternative to ex isting nicotine replacement therapies (NRTs), 
intended to assist in the cessation of smoking.  
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.  G/TBT/N/CAN/138 
Page 2  
 
Schedule F includes nicotine and its salts for hum an use as a medicinal ingredient, with the 
following exceptions:  
(a) in natural substances;  
(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit;  
(c) in the form of a transdermal patch with a de livery rate of 22 mg or less of nicotine per 
day; or  
(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or 
less of nicotine per dosage unit.  
Products in gum, patch and inhaler form ar e commonly used in smoking cessation therapy 
to relieve nicotine withdrawal symptoms.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 30 July 2005 
 
Therapeutic Products Directorate (TPD) web site:  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html, 
Project 1370, letter posted 4 August 2005 
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 6 to 8 months from the 
posting of the letter on the TPD web site. 
On the date the measure is adopted. 
10. Final date for comments:   18 October 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 Project No. 1370 can be downloaded at:   http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1370_e.html