. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/172 
23 August 2006 
 (06-3981) 
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 . 1441 — Schedule F) (4 pages, in English; 5 
pages, in French) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the propo sed addition of a medicinal ingredient to 
Part I of Schedule F to the Food and Drug Regulations . 
Description of the medicinal ingredient: Zaleplon  belongs to a class of drugs referred to as non-benzodiazepine hypnotics.  Other 
members of this class include zopiclone and zolpidem.  Zaleplon has been shown to decrease the time to sleep onset, however, it has not been shown to increase total sleep time 
or decrease the number of awakenings.  Zale plon is used for short-term treatment of 
insomnia, which is a disorder experienced wh en individuals find it difficult to fall asleep. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated  with this medicinal ingredient.  Oversight by a practitioner is G/TBT/N/CAN/172 
Page 2  
 
  necessary to ensure that adequate risk/benef it information is available before the drug 
containing the medicinal ingredient is administered and that the drug therapy is properly monitored. 
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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   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 No. 1441, letter posted: 15 August 2006 
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:   29 October 2006 
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. 1441 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1441_e.html