. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/125 
25 May 2005 
 (05-2107) 
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. 1451 — Schedule F) (4 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 prop osed addition of 3 medicinal ingredients to 
Part I of Schedule F to the Food and Drug Regulations  to the Food and Drugs Act . 
Description of the medicinal ingredients: 
1. Bortezomib  - is an antineoplastic agent for human  use in the treatment of multiple 
myeloma.  It belongs to a new pharmacological class called proteasome inhibitors. Bortezomib is administered intravenously for the treatment of recurring bone marrow 
tumours that are resistant to treatment.  
2. Memantine and its salts  - is an N-methyl-D-aspartate (N MDA) receptor antagonist.  It 
is used for the symptomatic treatment of pa tients with moderate to severe dementia of 
the Alzheimer's type.  G/TBT/N/CAN/125 
Page 2  
 
3. Nicotinic acid and its salts and its deriva tives in an extended release formulation 
providing 500 mg or more per dosage form or per daily dose - a lipid metabolism regulating agent used for the treatment of patients with abnormally high levels of 
cholesterol in the blood.  
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. 
The Drug Schedule Status Committee determined the necessity for prescription status for 
each of the medicinal ingredients in this pr oposed amendment on th e basis of established 
and publicly available criteria.  These crite ria include, but are not limited to, concerns 
related to toxicity, pharmacological pr operties 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 1451, letter posted: 
13 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:  27 July 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. 1451 can be downloaded at:   
http://www.hc-sc.gc.ca/hpfb-dgpsa/t pd-dpt/project_projet_1451_e.pdf