WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/162 
14 June 2006 
 (06-2880) 
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. 1481 - 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 proposed addition of eleven medicinal ingredients to Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredients: 
1. Alemtuzumab  is used for the treatment of B- cell chronic lymphocytic leukemia in 
patients who have been treated with othe r drugs and who have remission (less than 
6 months).  Alemtuzumab should be ad ministered under the supervision of a 
practitioner experienced in cancer therapy. 
2. Azelaic acid  is used in a topical gel for th e treatment of mild to moderate 
inflammatory acne and mild to moderate  rosacea, a chronic inflammatory skin 
disorder.  Azelaic acid helps the skin to  renew itself more quickly and therefore 
reduces pimple and blackhead formation.  It also helps to kill the bacteria that cause 
acne and rosacea. G/TBT/N/CAN/162 
Page 2  
 
  3. Bevacizumab  is a recombinant humanized monoclona l antibody that is used to treat 
cancer.  Bevacizumab slows the growth and spread of cancer cells in the body. 
4. Cetuximab  is a recombinant, chimeric monoclonal antibody that is used to treat 
patients with some types of cancer of the la rge intestine or rectum that have spread 
to other parts of the body. 
5. Darifenacin and its salts  is used for the treatment of overactive bladder associated 
with symptoms of urinary frequency, urin ary urgency, and urinary incontinence. 
Darifenacin relieves spasms of the bladder.  
6. Efalizumab  is a recombinant humanized monoclonal antibody that acts as an 
immunosuppressant, decreasing the activity of the body’s immune system. 
Efalizumab may relieve the signs and symptoms of moderate to severe chronic 
plaque psoriasis in adult patients. 
7. Emtricitabine  is an antiviral medication used to treat the human immunodeficiency 
virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS).  
8. Nitric Oxide  is used to dilate blood vessels in the lungs to treat critically ill 
newborn infants suffering from low levels of oxygen in respiratory failure 
associated with high blood pressure in  the lungs, a serious/life-threatening 
condition. 
9. Palifermin  is a human keratinocyte growth factor produced by recombinant DNA 
technology.  Palifermin is used to reduce the chance of developing sores and ulcers 
in the mouth and to shorten the time w ith sores or ulcers in patients with blood 
cancers who receive high doses of chemothera py and radiation therapy before bone 
marrow transplants.  
10. Pegvisomant  is a manufactured protein simila r to human growth hormone that 
blocks the effects of growth hormone.  Pegvisomant is used to treat acromegaly, a growth disorder caused by too much growth hormone, in patients who have had 
inadequate response to surgery, and/or radiation therapy, and other medical 
therapies, or for whom these th erapies are not appropriate.  
11. Tipranavir and its salts  is a protease inhibitor used to treat the human 
immunodeficiency virus (HIV) which ca uses acquired immunodeficiency syndrome 
(AIDS).  
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each me dicinal ingredient.  Oversight by a practitioner 
is necessary to ensure that ad equate risk/benefit 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  G/TBT/N/CAN/162 
 Page 3 
 
 
  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 1434 letter posted:  31 May 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the 
letter on the TPD website.  
Proposed date of entry into force:  On the date the measure is adopted.  
10. Final date for comments:   14 August 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. 1481 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1481_e.html