. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/167 
8 August 2006 
 (06-3815) 
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 . 1508 — Schedule F) (6 pages, in English; 7 
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 one medicinal ingredient to 
Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredient: 
Nicotinic acid  when sold in  
(a) a modified-release oral dosage form providing 500 mg or more per dosage 
unit or per daily dose; or 
(b) an immediate-release oral dosage form  providing more than 500 mg per 
dosage unit or per daily dose. 
Nicotinic acid at these doses acts as a lipid meta bolism regulating agent and is used for the 
treatment of patients with abnormally high levels of cholesterol in the blood.  G/TBT/N/CAN/167 
Page 2  
 
  The proposal to add nicotinic acid to Schedule F was initially part of Project 1451, which 
included proposals for two other medicinal ingredients (G/TBT/N/CAN/125).  The proposal, as part of Project 1451, included only the extended-release dosage form providing 500 mg or more per dosage unit or per daily do se.  In light of comments received during the 
consultation process, the proposal was reconsid ered and has been revised.  The following 
changes have now been incorporated: 
• Expanding the amendment to include immediate-release nicotinic acid 
providing more than 500 mg per dosage unit or per daily dose;  
• Adding oral dosage form;  
• Replacing the term “ extended-release ” by “ modified-release ” for consistency 
with the terminology used by Health Canada, and  
• Removing “ its salts and derivatives ” from the amendment as the salts and 
derivatives are not used to treat high blood cholesterol and do not have the same 
toxicity profile.  
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 adequate risk/benef it information is available 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. 1508, letter posted: 27 July 2006 
Proposed date of adoption:   Normally within 6 to 8 months from the 
posting of the letter on the TPD web site. 9. 
Proposed date of entry into force:    
On the date the measure is adopted. 
10. Final date for comments:   10 October 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. 1508 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1508_e.html