. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/211 
25 September 2007 
 (07-4029) 
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.:  +(613) 238 3222 Fax.: +(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. 1536 — 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 pr oposed addition of two medicinal ingredients 
to Part I of Schedule F to the Food and Drug Regulations . 
 Description of the medicinal ingredients: 
 
1. Micafungin and its salts  is an antifungal drug that is indicated for the treatment 
and prevention of fungal infections of th e esophagus in patients undergoing stem 
cell transplantation. Direct supervision by a practitioner is required. Micafungin and 
its salts is known to have undesirable or severe side effects at normal therapeutic 
dosage levels. Frequent laboratory mon itoring is required while using micafungin 
and its salts. 
 
2. Sitaxentan and its salts  is indicated for the treatment of pulmonary arterial 
hypertension (PAH), a rare progressive disease that is characterized by high blood pressure in the blood vessels leading to th e lungs. Diagnosis by a specialist in the G/TBT/N/CAN/211 
Page 2  
 
  area of PAH is required. Close medical supervision and routine laboratory 
monitoring are required due to the potential for adverse effects involving the liver. Sitaxentan and its salts may have undesi rable side effects at normal therapeutic 
dosage levels.  
 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associat ed with each medicinal ingredient. Oversight by a practitioner 
is necessary to ensure that ad equate risk/benefit information is available 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 huma n 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) website:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html, 
Project No. 1536, letter posted: 14 September 2007 
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:   28 November 2007 
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. 1536 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1536_e.html