. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/133 
24 June 2005 
 (05-2714) 
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. 1439 — Schedule F), (5 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 5 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. Adalimumab - is a synthetic protein that binds to tumor necrosis factor alpha and 
blocks its inflammatory effects in rheuma toid arthritis.  It reduces inflammation, 
tenderness and swelling of joints  in patients with rheumatoid arthritis, and slows or 
prevents the progressive destruction of joints in those patients.  
2. Cinacalcet and its salts  - is a calcimimetic. It activates calcium receptors and 
decreases the secretion of parathyroid hormone.  Cinacalcet is used to treat high 
serum calcium levels in patients with sec ondary over-activity of the parathyroid 
gland resulting from chronic kidney failure.  G/TBT/N/CAN/133 
Page 2  
 
3. Eletriptan and its salts - is a serotonin r eceptor agonist used for the acute treatment 
of severe migraine headaches.  Eletri ptan should only be used where a clear 
diagnosis of migraine has been establish ed and it should not be used to prevent 
migraine headaches.  
4. Frovatriptan and its salts  - is a serotonin receptor agonist and is used for the acute 
treatment of severe migraine headaches.  
5. Voriconazole  - is a triazole antifungal agent used  to treat life-threatening fungal 
infections in immune-compromised pa tients following chemotherapy or organ 
transplant.  Voriconazole is indicated fo r the treatment of a serious, often fatal 
fungal infection, which, due to the presence of flu like symptoms, could be easily 
mis-diagnosed by the public. 
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 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_r egulations_e.html, Project 1439, letter posted : 20 June 
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:   3 September 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. 1439 can be downloaded at:   
http://www.hc-sc.gc.ca/hpfb-dgpsa/t pd-dpt/project_projet_1439_e.pdf