. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/176 
30 August 2006 
 (06-4134) 
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. 1512 — Schedule F) (4 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 propo sed addition of three medicinal ingredients 
to Part I of Schedule F to the Food and Drug Regulations . 
Description of the medicinal ingredients: 1. Abatacept  is a synthetic protein produced by recombinant DNA technology that is 
used to treat rheumatoid arthritis.  It is used  alone or in combination with other medications 
to treat adults with moderate to severe rheuma toid arthritis who have  not been helped by 
other arthritis medications.  Abatacept is given by intravenous infusion and acts on the 
immune system to prevent activation of the ce lls that cause the destruction of joint tissue 
and cause the signs and symptoms of rheumati od arthritis.  Because abatacept depresses the 
immune system, it can reduce a patient's ability to fight both infection and cancer.  G/TBT/N/CAN/176 
Page 2  
 
  2.  Entecavir  is a nucleoside analogue used to tr eat chronic hepatitis B virus infection 
in adults with evidence of active disease or liver damage.  
3. Sunitinib and its salts  is a highly selective, multi-targeted tyrosine kinase inhibitor. 
It is used to treat patients with gastrointes tinal stromal tumors, a rare type of stomach 
cancer, where other treatments have not worked. It is also used to treat patients with 
advanced kidney cancer.  
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 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 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/legisla tion/acts-lois/notice-avis/index_e.html,  
Project No. 1512, letter posted: 18 August 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the letter 
on the TPD web site. 
Proposed date of entry into force:  On the date the measure is adopted. 
10. Final date for comments:   1 November 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. 1512 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1512_e.html