. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/268 
28 May 2009  
 (09-2574) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
  
NOTIFICATION 
 
The following notification is being circulated 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, Ontario, Canada, K1P 6N7 Tel.:  +1 613 238 3222, Fax.: +1 613 569 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 language(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Project No. 1595 — Schedule F) (5 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 four medicinal ingredients to Part I of Schedule F 
to the Food and Drug Regulations.  
Description of the medicinal ingredients: 1. Dabigatran and its salts and derivatives is an anticoagulant (blood thinner) agent used 
to prevent the formation of blood clots in the veins of the legs or lungs in patients who have undergone elective total hip replacement or total knee replacement surgery. 
Individualized instructions and direct supervision by a practitioner are required. The 
patient may also require treatment with other drugs and routine laboratory monitoring. Dabigatran and its salts and derivatives may cause undesirable or severe side effects at normal therapeutic dosage levels.  2. Nelarabine is used to treat specific types of cancer called T-cell acute lymphoblastic 
leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed following treatment with at least two 
chemotherapy regimens. Nelarabine should be administered under the supervision of a 
practitioner experienced in the use of anti-cancer drugs. Nelarabine may cause undesirable or severe side effects at normal therapeutic dosage levels. G/TBT/N/CAN/268 
Page 2  
 
  3. Nilotinib and its salts is used to treat a type of blood cancer called Philadelphia 
chromosome positive chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy. Individualized instructions and direct supervision by a practitioner are required. The patient may also require routine laboratory monitoring. Nilotinib and its salts may cause undesirable or severe side 
effects at normal therapeutic dosage levels.   
4. Rivaroxaban is an anticoagulant (blood thinner) agent used to prevent the formation 
of blood clots in the veins of patients who have undergone elective total hip replacement or total knee replacement surgery. Individualized instructions and direct supervision by a practitioner are required. The patient may also require treatment with other drugs 
and routine laboratory monitoring. Rivaroxaban may cause 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 associated with each medicinal ingredient. Oversight by a practitioner is necessary to ensure that appropriate risk/benefit 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 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  
8. Relevant documents:   Therapeutic Products Directorate (TPD) web site http://www.hc-
sc.gc.ca/dhp-mps/prodpharma/legislation/notice-avis/index-eng.php, Project No. 1595, letter posted: 20 May 2009   
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 August 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. 1595 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1595-eng.php