WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/218 
29 October 2007 
 (07-4674) 
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. 1540 - Schedule F)  (4 pages, available in 
English and French). 
6. Description of content:    
This notification announces the availability of a letter that provides an opportunity to 
comment on the proposed addition of five medicinal ingredients to Part I of Schedule F to 
the Food and Drug Regulations . 
 Description of the medicinal ingredients:  
- Dasatinib  is indicated for the treatment of adults with chronic myeloid leukemia 
(CML) who are no longer benefitting from other available therapies for CML. Dasatinib 
should be given under the supervision of a practitioner experienced in the use of anti-
cancer drugs. Dasatinib may cause undesirable or severe side effects at normal therapeutic dosage levels. The patient may al so require routine laboratory monitoring. 
 G/TBT/N/CAN/218 
Page 2  
 
  - Deferasirox  is used to treat chronic iron overloa d caused by blood transfusions for the 
treatment of anemia. Therapy with deferasi rox should be initiated and maintained by a 
practitioner experienced in the treatment of chronic iron overload due to blood transfusions. Individualized instructions a nd/or direct supervision by a practitioner is 
required for treatment with deferasirox. The patient may also require routine laboratory 
monitoring. 
 
- Lumiracoxib  is a non-steroidal anti-inflammatory drug (NSAID) that is used to treat 
pain and swelling in adults, such as oste oarthritis of the knee. Treatment with 
lumiracoxib requires individualized instructions  or direct supervision by a practitioner, 
particularly in patients with heart or liver disease. The patient may also require 
treatment with other drugs and routine la boratory monitoring. Lumiracoxib may cause 
undesirable or severe side effects at normal therapeutic dosage levels. 
 
- Posaconazole  is an antifungal agent that kills or stops the growth of some types of 
fungi that can cause infections in humans. Posaconazole is indicated for adult patients 
who have weakened immune systems due to other medicines or diseases. Individualized instructions or direct supervision by a pr actitioner are required. Posaconazole may have 
undesirable or severe side effects at normal therapeutic dosage levels.  
- Telbivudine  is indicated for the treatment of Hepatitis B in adults with chronic 
hepatitis B infection and active liver inflamma tion. Treatment with telbivudine requires 
practitioner supervision and routine lab monito ring particularly in patients with kidney 
disease. Telbivudine 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 appropriate risk/ben efit information is considered 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. 1540, 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 web site. 
On the date the measure is adopted. 
10. Final date for comments:   17 December 2007  G/TBT/N/CAN/218 
 Page 3 
 
 
  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. 1540 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1540_e.html