. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/128 
20 June 2005 
 (05-2605) 
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 (Notice of Intent  — Project No. 1421 — Schedule F) (pages 2051-2053, in English and French) 
6. Description of content:   This Notice of Intent (NOI) is to provide an opportunity to 
comment on the proposal to amend Part II of Schedule F to the Food  and Drug Regulations 
to provide an exemption to allow non-prescr iption status for 0.05 percent clobetasone 
butyrate in a cream formulation for topical use on the skin.  
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.  All 
strengths and dosage forms of clobetasone are currently included in Part II of Schedule F 
within the group listing:  Adrenocortical horm ones and their salts and derivatives (except 
hydrocortisone or hydrocortisone acetate, when so ld as a single medicinal ingredient in a  G/TBT/N/CAN/128 
Page 2  
 
 concentration that provides 0.5 percent hydrocor tisone in preparations for topical use on the 
skin)  
The proposed non-prescription product has the identical strength (0.05 percent), dosage 
form and route of administration to the prescr iption product;  however, certain restrictions 
on its use have been proposed to help ensure that consumers would use the product 
appropriately.  These restrictions would be included in the labelling. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 11 June 2005 
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:    25 August 2005 
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/2005/20050611/pdf/g1-13924.pdf