. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/126 
25 May 2005 
 (05-2108) 
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. 1445 — Schedule F) (3 pages, in English and French) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the proposed addition of Alefacept to Part I of 
Schedule F to the Food and Drug Regulations  to the Food and Drugs Act . 
Alefacept is a selective immunomodulating agent.  It is used for the treatment of patients 
with moderate to severe chronic plaque psoriases who are candidates for light therapy or systemic treatment.  
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. G/TBT/N/CAN/126 
Page 2  
 
The Drug Schedule Status Committee determined the necessity for prescription status for 
the medicinal ingredient in this proposed  amendment on the basis of established and 
publicly available criteria.  These 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 health 
8. Relevant documents:   Therapeutic Products Directorate (TPD) web site 
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_ regulations_e.html, Project 1445, letter 
posted:  18 May 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:  1 August 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. 1445 can be downloaded at:   
http://www.hc-sc.gc.ca/hpfb-dgpsa/t pd-dpt/project_projet-1445_e.pdf