. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/380 
8 January 2013  
 (13-0062) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  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 St reet, 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 fo r human use (ICS:11.120) 
5. Title, number of pages and language(s) of the notified document:  Proposed amendments 
to the Food and Drug Regulations  (1688 - Arsenic Trioxide) (4 pages, in English and 
French).     
6. Description of content:  The Food and Drug Regulations  (Subsection C.01.040 (b)) prohibit 
manufacturers or importers from selling a drug fo r human use that contains arsenic or any of 
its salts or derivatives. Clinical trials showed that arsenic trioxide is highly effective when 
used as a treatment for patients with relapsed acute promyelocytic leukemia (APL).  
This proposal would exempt the sale of a drug th at contains arsenic trioxide as a medicinal 
ingredient from the prohibition contained in subsection C.01.040 (b) of the Regulations.  
This amendment would also add arsenic trioxide wh en used as a medicinal ingredient to Part I 
of Schedule F to the Regulations.  Schedule F to the Food and Drug Regulations  lists 
medicinal ingredients that are re quired to be sold pursuant to a prescription when sold as a 
drug in Canada.  Arsenic trioxi de is proposed to be sold pursuant to prescription because 
direct supervision by a practitioner is required along with routine medical monitoring. As with 
all antineoplastic agents, there are potential or known undesirable or severe side effects at 
normal therapeutic dosage levels.  
Market approval for arsenic trioxide pursuant to  a prescription has been granted by the United 
States Food and Drug Administration, the Euro pean Medicines Agency  and the Therapeutic 
Goods Administration of Australia. G/TBT/N/CAN/380 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette , Part I, 15 Decembe r 2012, Pages 3539-3542 
(Available in English and French)   
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 8 to 10 months of publication 
in the Canada Gazette , Part I. 
These Regulations come into force on the day on which they are published in the Canada 
Gazette , Part II.  
10. Final date for comments:  28 February 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of the regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-pr/p1/2012 /2012-12-15/pdf/g1-14650.pdf#page=165 ( Canada 
Gazette )  
or 
http://www.gazette.gc.ca/rp-pr/ p1/2012/2012-12-15/html/reg6-eng.html   (English) 
http://www.gazette.gc.ca/rp-pr/ p1/2012/2012-12-15/html/reg6-fra.html   (French)