. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/175 
30 August 2006 
 (06-4130) 
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. 1511 — Schedule F) (3 pages, in English;
4 pages, in 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 a medicinal ingredient to 
Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredient: Pregabalin and its salts and derivatives  - is used for the management of neuropathic pain 
(chronic pain that arises from damage to senso ry nerves) associated with diabetic peripheral 
neuropathy (pain caused by nerve damage associ ated with diabetes) and post herpetic 
neuralgia (pain following an outbreak of herpes zoster, known as "shingles").  Neuropathic 
pain generally does not respond to treatment w ith narcotic analgesics or non-steroidal anti-
inflammatory drugs.   G/TBT/N/CAN/175 
Page 2  
 
  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 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. 
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 No. 1511, letter posted: 18 August 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the letter 
on the TPD web site. 
Proposed date of entry into force:  On the date the measure is adopted.      
10. Final date for comments:   1 November 2006 
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. 1511 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1511_e.html