. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/231 
26 March 2008 
 (08-1320) 
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, Fa x.: +(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 . 1578 — Schedule F) (4 pages, available in 
English and French). 
6. Description of content:    
This notification announces the availability of a letter that provides an opportunity to 
comment on the proposed addition of four medicinal ingredients to Schedule F, Part I to the 
Food and Drug Regulations . 
 Description of the medicinal ingredients:  
1. Aliskiren and its salts  is the first of a new pharmalogical class of medicines called renin 
inhibitors. It is used to treat mild to mode rate hypertension (high blood pressure). Aliskiren 
and its salts may be used alone or togeth er with other blood pressure medications. 
Individualized instructions and direct superv ision by a practitioner are required. Aliskiren 
and its salts may have undesirable or severe si de effects at normal therapeutic dosage levels. 
 
2. Anidulafungin  is an antifungal medication that is indicated for the treatment of serious, 
often fatal fungal infections. Direct practitione r intervention is required for diagnosis, 
supervision of drug administration and o ngoing assessment of treatment. Anidulafungin 
requires specialized non-routine laboratory t esting and monitoring procedures to ensure 
maximum benefit from therapy.  G/TBT/N/CAN/231 
Page 2  
 
  3. Lanreotide and its salts  is used for the long-term treatment of excessive growth 
(acromegaly) due to pituitary tumors in patie nts who have had inadequate response to or 
cannot be treated with surgery and/or radiation. Lanreotide and its salts must be administered by deep injection under the skin and requires laboratory monitoring during treatment. Lanreotide and its salts may have undesirable or severe side effects at normal 
therapeutic dosage levels. 
 
4. Raltegravir and its salt s is an antiretroviral agent that is used in combination with other 
antiretroviral drugs to treat HIV-1 infection.  Administration of raltegravir and its salts 
requires direct practitioner supervision and routine laboratory monitoring, including 
assessment of treatment efficacy. Raltegravir and its salts may have 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 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 admini stered 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) web site  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma /legislation/notice-avis/index_e.html , Project 
No. 1578, letter posted: 13 March 2008. 
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 May 2008 
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. 1578 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/notice-
avis/project_projet_1578_e.html