. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/244 
4 July 2008 
 (08-3226) 
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, Onta rio, Canada, K1P 6N7 Tel.:  +1 613 238 3222, 
Fax.: +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 . 1590 — Schedule F) (4 pages, available in 
English and French) 
6. Description of content:    
The purpose of this letter is to provide an op portunity for comment on the proposed addition 
of one medicinal ingredient to Part I of Schedule F to the Food and Drug Regulations . 
 
Description of the medicinal ingredient: 
Lenalidomide is used in the treatment of patients with certain types of myelodysplastic 
syndromes (MDS) who require red blood cell tr ansfusions to manage low red blood cell 
counts (anemia). MDSs are a group of diseases of the blood and bone marrow in which the 
bone marrow does not make enough healthy bloo d cells. Individualized instructions or 
direct supervision by a practitioner is requi red. The patient may also require routine 
laboratory monitoring. Lenalidomide may cause und esirable 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 administered and that the drug therapy is properly monitored. G/TBT/N/CAN/244 
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) website: 
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/notice-avis/index-eng.php, Project 
No. 1590, letter posted: 26 June 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 website.On the date the measure is adopted. 
10. Final date for comments:   9 September 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. 1590 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/notice-avis/project_projet_1590-
eng.php