. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/282 
9 October 2009  
 (09-4914) 
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 : 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Project No. 1597 — 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 to 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.  Idebenone is a benzoquinone derivative that is used to manage symptoms of Freidreich’s 
Ataxia. Freidreich’s Ataxia is an inherited disease that causes progressive damage to the nervous system, resulting in symptoms rangi ng from difficulty walking to speech problems 
and also frequently leads to heart disease. Idebenone should only be prescribed by, or 
following consultation with, practitioners w ho are experienced in the diagnosis and 
management of Freidreich’s At axia. Direct supervision by a practitioner is required during 
treatment. 
2. Idursulfase is an enzyme that is manufa ctured using recombinant deoxyribonucleic acid 
(DNA) technology. Idursulfase is used to treat deficiency ofthe enzyme, iduronate-2-
sulfatase, in patients with Hunter syndrome, a seriousprogressive gene tic disorder that can 
result in permanent damage such as visi onand hearing loss, heart disease, breathing 
difficulties and joint stiffness. Direct supe rvision by a practitioner and routine laboratory 
monitoring are required. G/TBT/N/CAN/282 
Page 2  
 
  3.  Nesiritide belongs to a new drug clas s that is manufactured using recombinant 
deoxyribonucleic acid (DNA ) technology. Nesiritide is used to  treat patients in hospital who 
have symptoms of heart failure and have not re sponded to treatment with other drugs. Direct 
supervision by a practitioner is required. Nesiri tide 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. 1597, letter 
posted: 30 September 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 website. 
On the date the measure is adopted. 
10. Final date for comments:  14 December 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. 1597 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1597-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1597-fra.php  
(French)