. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/219 
29 October 2007 
 (07-4675) 
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) 61 3238 3222 
Fax.: (+1) 61 3569 7808 E-mail: 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. 1576 - Schedule F)  (available in English, 3 
pages; and French, 4 pages). 
6. Description of content:    
This notification announces the availability of a letter that provides an opportunity to 
comment on the proposed addition of two medicinal ingredients to Part I of Schedule F to 
the Food and Drug Regulations . 
 Description of the medicinal ingredients:  
- Oxaliplatin  is used to treat patients with advan ced colorectal cancer. Oxaliplatin is 
used in combination with other medicati ons and should be administered under the 
supervision of a practitioner experienced in  the use of anti-cancer drugs. Oxaliplatin 
may cause undesirable or severe side effect s at normal therapeutic dosage levels. 
  G/TBT/N/CAN/219 
Page 2  
 
  - Ranibizumab  is used to treat damage to the eye associated with abnormal blood 
vessel growth in the retina. This conditio n can occur in diseases such as age-related 
macular degeneration (AMD). Treatment with ranibizumab must be administered by a 
qualified ophthalmologist experienced in performing injections into the eye. 
Ranibizumab may have undesirable or severe side effects at normal therapeutic dosage 
levels.  
 The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associat ed with each medicinal 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 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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. 
8. Relevant documents:   
Therapeutic Products Directorate (TPD) website  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html, 
Project No. 1576, letter posted: 3 October 2007. 
 
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 website. 
On the date the measure is adopted. 
10. Final date for comments:   17 December 2007 
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. 1576 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1576_e.html