. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/120 
4 April 2005  
 (05-1341) 
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):   Medicinal ingredients 
which require a prescription 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 (1184 - Modafinil - Schedule F) (pages 966-969, in English and French) 
6. Description of content:   The Therapeutic Products Directorate (TPD) of Health Canada 
proposes to add the medicinal ingredient modafin il and its salts to Part I of Schedule F to 
the Food and Drug Regulations. 
Modafinil is a non-amphetamine central nervous system stimulant that increases levels of 
alertness in patients whose level of alertness is be low normal. It is used for the treatment of 
excessive daytime sleepiness in patients with na rcolepsy, a medical condition in which there 
are recurrent, uncontrollable, brief episodes of sleep. Modafinil should not be used for the 
treatment of normal fatigue states. There is no evidence that normal levels of alertness can be heightened by modafinil. 
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.046 of the Food and Drug Regulations. Part I of Schedule F lists medicinal ingredients which require a prescrip tion for both human and veterinary use.  G/TBT/N/CAN/120 
Page 2  
 
The Drug Schedule Status Committee reviews th e status of chemical entities proposed for 
marketing as medicinal ingredients in drug pr oducts. The decision regarding the necessity 
for prescription versus non-prescription status was made on the basis of established and 
publicly available criteria. These criteria include, but are not limited to, concerns relating to toxicity, pharmacologic properties, and ther apeutic applications. The recommended degree 
of regulatory control is based on the risk fact ors associated with each specific drug and each 
drug's potential for abuse. Prescription status will help to ensure that consumers receive 
adequate risk/benefit information from a medi cal practitioner before taking the medication. 
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 2005 
9. Proposed date of adoption: 
Proposed date of entry into force:   } Not stated. 
10. Final date for comments:    9 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 these do cuments can be downloaded at: 
 http://canadagazette.gc.ca/partI/2005/20050326/pdf/g1-13913.pdf