. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/213 
25 September 2007 
 (07-4041) 
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. 1575 — 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 
Part I of Schedule F to the Food and Drug Regulations . 
 Description of the medicinal ingredient: 
 
Inhaled human insulin  is used for the treatment of a dult patients with diabetes for the 
control of high blood sugar. Inhaled human insulin  is a rapid-acting form of insulin that may 
be used alone or in combination with oral an tidiabetic agents and/or  long or intermediate 
acting injectable insulins to optimize blood sugar control. Although injectable forms of insulin are not listed on Schedule F, it is reco mmended that the inhaled form be added to 
Schedule F. Inhaled human insulin has a rapid onset following administration. In addition, 
absorption of inhaled human insulin is dependa nt on adequate lung function in the patient. 
Lung function must be measured by a practiti oner before beginning treatment and then 
monitored routinely thereafter. The starting and subsequent dosage must be determined 
individually by a practitioner and adjusted according to the patient's lung function and G/TBT/N/CAN/213 
Page 2  
 
  response to the drug dosage in relation to diet and activity level. The long-term effects of 
inhaled insulin are unknown at this time as ther e has not been a sufficient period of use to 
clarify the effects in humans.  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 consid ered 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/legi slation/acts-lois/notice-avis/index_e.html 
Project No. 1575, letter posted: 17 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 web site. 
On the date the measure is adopted. 
10. Final date for comments:   1 December 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. 1575 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1575_e.html