. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/200 
11 June 2007 
 (07-2420) 
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. 1551 — 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 propo sed addition of one medicinal ingredient to 
Schedule F, Part I to the Food and Drug Regulations . 
Description of the medicinal ingredient: 
Lanthanum salts when sold for th e treatment of hyperphosphatemia  are phosphate 
binders used to reduce blood levels of phos phate in patients with kidney disease who are 
receiving dialysis treatment. Lanthanum salts act in the digestive system to prevent absorption of phosphate that is rel eased from food during digestion.  
 The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated  with this medicinal 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 admini stered and that the drug therapy is properly 
monitored. G/TBT/N/CAN/200 
Page 2  
 
  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/aNcts-lois/notice-
avis/index_e.html 
Project No. 1551, letter posted: 25 May 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 web site. 
On the date the measure is adopted 
10. Final date for comments:   8 August 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. 1551 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1551_e.html