. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/145 
20 October 2005 
 (05-4836) 
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. 1476 — 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 prop osed addition of 2 medicinal ingredients to 
Part I of Schedule F to the Food and Drug Regulations  to the Food and Drugs Act . 
Description of the medicinal ingredients: 
1. Erlotinib and its salts  is an epidermal growth factor  receptor (EGFR) tyrosine kinase 
inhibitor, which is a relatively new therapeutic class.  It is indicated for the treatment of 
patients with locally advanced or metast atic non-small cell lung cancer (NSCLC) after 
failure of at least one prior chemotherapy regimen.  
2. Lutropin alfa  for injection is a recombinant human luteinizing hormone (r-hLH).  It is 
used together with follitropin alpha for in jection (GONAL-F) for fertility treatment in 
hypogonadotropic hypogonadal (HH) women w ith profound luteinizing hormone (LH) 
deficiency. HH is a rare endocrine deficiency.  G/TBT/N/CAN/145 
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 human 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. 
The Drug Schedule Status Committee determines the necessity for prescription status for 
medicinal ingredients on the basis of estab lished and publicly available criteria. These 
criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients. 
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/legisl ation/acts-lois/notice-avis/index_e.html 
Project 1476, letter posted:  4 October 2005. 
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:   18 December 2005 
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. 1476 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpha rma/legislation/acts-lois/notic e-avis/project_projet_1476_e.html