. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/297 
21 January 2010  
 (10-0316) 
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, 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 : 11.220) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Project No. 1627 — Schedule F) (5 pages, available in 
English and French)     
6. Description of content:  This notification announces the availa bility of a letter that provides 
an opportunity for comment on the proposed additi on of three medicinal ingredients to Part I 
of Schedule F to the Food and Drug Regulations.  
Description of the medicinal ingredients: 
1.  Golimumab is a human monoclonal antibody that acts on the immune system and is used 
to treat adults with active forms of rheumatoid  arthritis, psoriatic arthritis (inflammatory 
diseases of the joints), and ankylosing spondylitis  (inflammatory disease of the spine). Direct 
supervision by a practitioner is required during tr eatment and routine laboratory monitoring is 
required. Golimumab may cause undesirable or severe side effects at normal therapeutic 
dosage levels. 
2. Lapatinib and its salts is an anti-cancer dr ug that is used to treat patients with HER2+ 
(receptor positive) breast cancer  that is advanced or has spread to other parts of the body. 
Direct supervision by a practitioner is re quired during treatment and routine laboratory 
monitoring is required. Lapatinib and its salts ma y cause undesirable or se vere side effects at 
normal therapeutic dosage levels. G/TBT/N/CAN/297 
Page 2  
 
   3. Vorinostat is an anti-cancer drug that is us ed to treat patients with advanced cutaneous T-
cell lymphoma (a cancer of the immune system ) in whom the disease has persisted, become 
worse or returned following treatment with othe r drugs. Individualized in structions and direct 
supervision by a practitioner are required during treatment and routine laboratory monitoring 
is required. Vorinostat 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 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. 1627, letter 
posted: 11 January 2010   
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:  27 March 2010 
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. 1627 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1627-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1627-fra.php  
(French)