. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/212 
25 September 2007 
 (07-4040) 
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. 1550 — Schedule F) (4 pages, in English 
and French). 
6. Description of content:    
This notification announces the availability of a letter that provides an opportunity to 
comment on the proposed addition of two medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations . 
Description of the medicinal ingredients: 
1. Acamprosate and its salts  is indicated for the maintenance of abstinence from 
alcohol in patients with alcohol dependence.  The safe and effective use of this drug 
requires that a practitioner evaluate the warnings and precautions associated with acamprosate use, particularly in patients with kidney or liver disease. The patient may also require continuous follow-up a nd support by a practitioner. Acamprosate 
may have undesirable or severe side effects at normal therapeutic dosage levels. 
 
2. Varenicline and its salts  is indicated as a smoking cessation aid in adults. The safe 
and effective use of this drug requires that a practitioner evaluate the warnings and G/TBT/N/CAN/212 
Page 2  
 
  precautions associated with varenicline use,  particularly in patients who might also 
use other nicotine replacement therapies, a nd in patients with a serious illness such 
as epilepsy or heart disease.  
 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.  
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/acts-lois/notice-avis/index_e.html, 
Project No. 1550, 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. 1550 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1550_e.html