. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/256 
26 January 2009  
 (09-0349) 
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 governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Department of Health 
Name and address (including telephone and fax numbers, email and website 
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, Ontari o, Canada, K1P 6N7 Tel.:  +1 613 238 3222, 
Fax.: +1 613 569 7808, Email: enquirypoint@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. 1591 — Schedule F)  (7 pages, available in 
English and French).  
6. Description of content:  The purpose of this letter is to provide an opportunity for comment 
on the proposed addition of eight medicinal ingred ients to Part I of Schedule F to the Food 
and Drug Regulations.  
Description of the medicinal ingredients: 
1. Ambrisentan is an endothelin  receptor antagonist that is us ed to treat pulmonary arterial 
hypertension (PAH), a condition characterize d by high blood pressure in the pulmonary 
artery.  
2. Etravirine and its salts is an HIV non-nucleoside reverse tr anscriptase inhibitor (NNRTI). 
Etravirine and its salts is used in the trea tment of human immunodeficiency virus type 1 
(HIV-1) infection in patients for whom other HIV treatments are not effective.  
3. Methoxy polyethylene glycol-epoetin beta  is a polymer-based erythropoietic compound 
that increases the number of red blood cells and hemoglobin level in the blood. Methoxy 
polyethylene glycol-epoetin beta is used for the treatment of anemia in patients with chronic 
kidney disease.  
4. The current listing for 'naltrexone and its salt s' is revised to 'naltr exone and its salts and 
derivatives'. The revised listing is necessar y to include the new medicinal ingredient, G/TBT/N/CAN/256 
Page 2  
 
  methylnaltrexone bromide, a derivative of nalt rexone. Naltrexone and its salts and derivatives 
are opioid receptor antagonists, which block or  lessen the action of opioid drugs such as 
morphine without causing a biol ogical response of their own.  Methylnaltrexone bromide acts 
by reducing the effect of opioid drugs on the intest inal tract and is used to treat constipation in 
patients with advanced illness such as incu rable cancer who are receiving opioid drugs on a 
continuous basis to alleviate pain. Methylnaltr exone bromide is admini stered by injection 
under the skin. 
5. Nepafenac is a nonsteroidal anti-inflammator y drug (NSAID) that is used for management 
of eye pain and inflammation associated with cataract surgery.  
6. Panitumumab is a monoclonal antibody that acts on certain types of cancer cells and may 
prevent the cancer cells from growing or dividing.  Panitumumab is used to treat cancer of the 
colon or rectum that has spread to other parts of the body.  
7. Retapamulin is a topical antibiotic ointment th at is used to treat bacterial skin infections 
such as impetigo and small infected cuts, abrasions and sutured wounds.  
8. Sitagliptin and its salts is a member of a ne w class of medicines called dipeptidyl peptidase-
4 (DPP-IV) inhibitors used to treat type II di abetes. Sitagliptin is us ed to improve blood sugar 
level in patients with type 2 diabetes mellitus in addition to diet and exercise.  
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each medi cinal ingredient. Oversight by a practitioner is 
necessary to ensure that appropriate risk/benef it information is considered before the drug 
containing the medicinal ingredient is administ ered and that the drug therapy is properly 
monitored. 
Schedule F is a list of medicinal ingredients, th e sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulatio ns. Part I of Schedule F lists ingredients 
that require a prescription for human use and fo r veterinary use. Part II of Schedule F lists 
ingredients that require a prescription for hu man 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  
8. Relevant documents:   Therapeutic Products  Directorate (TPD) we b site http://www.hc-
sc.gc.ca/dhp-mps/prodphar ma/legislation/notice-avis/index-e ng.php, Project No. 1591, letter 
posted: 31 December 2008   
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:  16 March 2009 
11. Text available from: National enquiry po int [ X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of Project No. 1591 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/notice-avis/project_projet_1591-eng.php