. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/230 
7 March 2008 
 (08-1005) 
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 St reet, Ottawa, Ontario, 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 (Notice of Intent — Project No. 1584 — Schedule F) (available in English and French, 3 pages). 
6. Description of content:    
This Notice of Intent (NOI) is to provide an opportunity to comment on the proposal to 
amend Part I of Schedule F to the Food and Drug Regulations  to revise the listing for 
naproxen and its salts to allow non-prescription st atus when sold for oral use with a daily 
dose of 440 mg.  “Naproxen and its salts” is currently listed in  Part I of Schedule F without any qualifying 
phrases or exceptions. This means that all stre ngths of naproxen and its salts currently 
require a prescription in order to be sold in Canada. 
 The availability of a non-prescription naproxen a nd its salts with a 440-mg daily dose would 
provide consumers with another option for sel f-treatment of mild to moderate pain. 
 
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. G/TBT/N/CAN/230 
Page 2  
 
  Description: 
 Naproxen and its salts is a non- steroidal anti-inflammatory drug (NSAID) that is used to 
treat inflammation and pain. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 1 Ma rch 2008, Pages 490-492 (available in 
English and French). 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months of publication 
in the Canada Gazette, Part I. 
On the date the measure is adopted. 
10. Final date for comments:   15 May 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 the Notice of  Intent can be downloaded at:  
http://canadagazette.gc.ca/partI/2008/20080301/pdf/g1-14209.pdf  (Canada Gazette) 
or http://canadagazette.gc.ca/partI/2008/20080301/html/notice-e.html#d103  (English)
 
http://canadagazette.gc.ca/partI/2008/20080301/html/notice-f.html#d103   (French)