WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/206 
24 July 2007 
 (07-3148) 
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 . 1528 — Schedule F) (6 pages, available 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 proposed correction to one current listing on 
Schedule F, Part I to the  Food and Drug Regulations  and the proposed addition of seven 
medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations . 
 Correction of one current Schedule F, Part I listing
 
The current listing in Schedule F, Part I: Botulinum Toxin Type A Antitoxine botulinique, Type A 
is revised to: 
Botulinum toxin Type A  
Toxine botulinique, type A  G/TBT/N/CAN/206 
Page 2  
 
  Additions to Schedule F, Part I
 
 
Description of the medicinal ingredients: 
 1. Alglucosidase alfa  is a synthetic protein produced by recombinant DNA technology 
that is used to treat individuals with Pomp e disease. Pompe disease is a rare, but serious, 
genetic disorder in which a person's muscl e and respiratory function are drastically 
reduced.  
 2. Ciclesonide  is a corticosteroid for oral inhalation that can help to ease breathing 
problems in adult asthma patients. Asthma is a chronic inflammatory disease of the 
lungs. Ciclesonide relieves swelling and irrita tion in the small air passages in the lungs.  
 3. Darunavir  is a protease inhibitor that is used  to treat Human Immunodeficiency Virus-
1 (HIV-1) infection in adults. Darunavir is administered in combination with another 
anti-HIV medication.  
 4. Natalizumab is a monoclonal antibody used to treat patients with the relapsing-
remitting form of multiple sclerosis (MS), a disease of the central nervous system. 
Natalizumab is generally recommended in MS  patients who have had an inadequate 
response to, or are unable to tolerate, other therapies for multiple sclerosis. Natalizumab 
should not be administered in combination w ith other immune system modifying drugs.  
 5. Rasagiline and its salts  is a monamine oxidase inhibitor (MAOI) used to treat the signs 
and symptoms of Parkinson's disease, a disorder of the central nervous system.  
 
6. Sorafenib and its salts  is used to treat advanced kidney  cancer in adults for whom other 
anti-cancer therapies have failed or are considered unsuitable. Sorafenib acts by slowing down the rate of tumor growth and cutting off the blood supply that keeps tumors growing.  
 
7. Tigecycline  is an antibiotic that is administer ed intravenously to treat complicated 
infections of the skin and abdominal organs.  
 
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 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 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. 1528, letter posted: 6 July 2007  G/TBT/N/CAN/206 
 Page 3 
 
 
  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:   19 September 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. 1528 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1528_e.html