. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/154 
14 March 2006 
 (06-1147) 
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 . 1463 - 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 pr oposed addition of two medicinal ingredients 
to Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredients: 
1. Paricalcitol  is a synthetic Vitamin D 2 analogue that is indicated for the prevention 
and treatment of overactivity of the para thyroid glands associated with chronic 
kidney failure in hemodialysis patients. Th e drug is given into the dialysis lines 
during hemodialysis.  
 G/TBT/N/CAN/154 
Page 2  
 
  2. Pegaptanib and its salts  is a selective vascular endothelial growth factor (VEGF) 
antagonist. Pegaptanib and its salts is indicated for slowing vision loss in patients 
with neovascular (wet) age-related macular degeneration (AMD), a leading cause of 
irreversible severe vision loss in patients ol der than 50 years of age. Pegaptanib is 
the first in a new class of ophthalmic drugs  that specifically target VEGF, a protein 
which acts as a signal in triggering the abnormal blood vessel growth and leakage of neovascular AMD.  
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 huma n 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 determines the necessity for prescription status for 
medicinal ingredients on the basis of estab lished and publicly available criteria. These 
criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. 
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 1463 letter posted : 8  March 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:   22 May 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. 1463 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1463_e.html